Research Studies

The Center for Information and Study on Clinical Research Participation (CISCRP) is currently planning a half-day, in-person patient advisory board meeting among individuals diagnosed with or caring for a loved one with schizophrenia on November 5 in NYC from 9:30 am  to 2:30 pm. CISCRP is a non-profit organization based in Boston, Massachusetts, dedicated to including the patient voice in the clinical research process for it to be more ‘patient-centered’ and to help reduce any barriers for future study volunteers. As part of our mission, we regularly engage with patients through advisory board meetings, global surveys, and workshops to include the patient voice in research endeavors.

We are looking for individuals in the NY area who have experienced an acute episode in the past but are currently stable to share personal experiences and feedback in an open and honest discussion. During this patient advisory board, individuals will be asked to share experiences regarding the impact schizophrenia has had on their personal life; satisfaction with current treatments; interactions with healthcare professionals; perceptions of clinical trials; and feedback on a proposed clinical trial design for schizophrenia.

The goal of the meeting is not to recruit patients for a clinical trial, but rather to obtain insight into the patient/caregiver experience and to help reduce the burdens of future study volunteers by addressing the unique needs of people living with Schizophrenia.

As a thank you for participating, CISCRP will provide an honoraria to those who are eligible and attend the meeting, as well as breakfast, lunch, and reimbursements for travel associated with the meeting. We are also happy to help organize any needed travel arrangements.

If you are interested in this opportunity, please contact Bevin Edwards at 617-725-2750 x402 or email her at bedwards@ciscrp.org for more details! She is more than happy to discuss the project with you and answer any questions you may have!

Looking for voluntary research participants who fit the following criteria:

• male or female between 18 and 65 years old
• diagnosed with schizophrenia or schizoaffective disorder

The purpose of this study is to study the effectiveness, safety and tolerability of different doses and durations of an investigational treatment called TV-46000 given by subcutaneous (under the skin) injection as compared to placebo for use as a potential maintenance treatment. TV-46000 is a risperidone extended-release injectable suspension for subcutaneous (sc) use that will deliver therapeutic levels of risperidone over intervals of 1 month (q1m) or 2 months (q2m) to patients with schizophrenia. TV-46000 is a new formulation of risperidone that uses a sustained-delivery technology. TV-46000 is intended to maintain enough levels of risperidone in your body for 1 or 2 months following a single subcutaneous injection. With the injections, a small “depot” of study medication is created under the skin and then the medication is slowly released over time. This is a potential advantage over the currently available two-week injectable form of risperidone. The purpose of the study is to compare the safety and efficacy of different durations of TV-46000 administered subcutaneously versus placebo.

Noncompliance and high discontinuation rates are particularly problematic in patients with schizophrenia. Premature discontinuation of antipsychotic drug therapy is a common phenomenon; in one large study comparing the best available oral medications, 74% of patients discontinued their antipsychotic drug within 18 months due to either poor tolerability or lack of efficacy. Even among patients who do not explicitly discontinue drug therapy, nonadherence to long-term oral medication regimen is one of the most significant therapeutic issues in the therapy of schizophrenia and related disorder. As a result, many of these patients do not experience the full benefit of antipsychotic drug
therapy and suffer frequent relapses or exacerbations that require rehospitalization, often in the context of psychiatric emergency. Thus, the use of a long-acting injectable (LAI) antipsychotic agent may increase compliance in patients with schizophrenia (PSF).

You will receive oral risperidone for 12 weeks and then be randomized (like flipping a coin) to TV- 46000 or placebo. Whether you receive TV-46000 or placebo is decided by chance. You will not learn during the study whether you received TV-46000 or placebo. The study is divided into 3 main parts: Pretreatment, Double-blind Maintenance, and Follow-up/Exit. Pretreatment Period includes the Screening and Stage 1 (Oral Conversion and Stabilization Stage) which has 5 visits and lasts up to 16 weeks. There is an initial screening visit to assess your medical and psychiatric history and symptoms of schizophrenia. You will have a physical exam and blood and urine will be obtained. After you start the study medication, we will monitor your schizophrenia symptoms and overall health throughout the study. You will have visits every 2 weeks during the Pretreatment Period and every week for 12 weeks and then every four weeks thereafter during the Double-Blind Maintenance Stage (open-ended, variable length). Study exit/follow up consists of two visits over 8 weeks.

You will not receive any payment for taking part in the study. To compensate you for your lost productivity associated with attending study visits, we will provide you with a stipend. You will receive a screening stipend in the amount of $75.00 paid via cash. Starting at visit 2, you will receive $75.00 for each clinic visit to compensate for expenses directly related to participation in the Study (such as transportation, meals and parking fees) and $30 for each telephone contact visit through the Greenphire Debit card reimbursement. The stipend for the clinic visits also will serve as reimbursement for travel expenses related to your participation in this study. You do not have to complete the study in order to receive reimbursement for your travel expenses. You will be reimbursed after each completed visit.

Person to Contact: if you have questions or if you would like to participate in this study call 646-774-8496 or e-mail melissa.conant@nyspi.columbia.edu.

When does the study expire?: Data collection for this study began in September 2018 and is scheduled to end in September 2021.

The study is conducted to determine the effects of initial treatment and re-treatment(s) with SAGE-217 in adults with Major Depressive Disorder (MDD) currently experiencing a major depressive episode (MDE) over a 1-year period. Qualified subjects will self-administer SAGE-217 30 mg orally once daily in the evening with food for 14 days.

Number of site visits required: 5 visits

You could be eligible for this study if:

• You have a diagnosis of MDD as diagnosed by SCID-5-CT, with symptoms that have been present for at least a 4-week period.
• You are in good physical health and have no clinically significant findings, as determined by the Investigator, on physical examination, 12-lead ECG, or clinical laboratory tests

You may not be eligible for the study if:

• You have attempted suicide associated with the current episode of MDD.
• You have a medical history of bipolar disorder, schizophrenia, and/or schizoaffective disorder.
• You have had vagus nerve stimulation, electroconvulsive therapy, or has taken ketamine (including esketamine) within the current major depressive episode.

Will subjects be paid? Include amount and payment schedule.: 80 $ per visit

A person to contact, and a website for more general information:
Anastasiya Drovnyashina
Clinical Research Coordinator at Integrative Clinical Trials, LLC
Direct 718.444.7774 Ext: 117
Anastasiya.Drovnyashina@iclinicaltrials.net
www.iclinicaltrials.net

Post expires: 1 year

The purpose of this study is to evaluate the efficacy of adjunctive pimavanserin compared to placebo in subjects with major depressive disorder who have an inadequate response to antidepressant therapy.

The duration of participation for individual study subjects will be up to 14 weeks, consisting of a screening period of up to 4 weeks, a 6-week double-blind treatment period, and a safety follow-up period of at least 30 days. Patients will be given Pimavanserin 34 mg (provided as 2×17 mg tablets) or matching placebo (2×placebo tablets [size- and color-matched to pimavanserin]) to evaluate the efficacy of the study drug to placebo in patients with major depressive disorder.

Number of site visits required: 9 visits

You could be eligible for this study if:

• A clinical diagnosis of major depressive disorder (MDD)
• Is being treated with one of the following SSRI or SNRI antidepressants:
  • Citalopram
  • Escitalopram
  • Paroxetine
  • Fluoxetine
  • Sertraline
  • Duloxetine
  • Venlafaxine
  • Desvenlafaxine
  • Venlafaxine XR
• Inadequate response to SSRI/SNRI antidepressant treatment is confirmed
• If the subject is female, she must not be pregnant or breastfeeding. She must also be of non-childbearing potential OR must agree to use acceptable methods of contraception

You may not be eligible for the study if:

• Has a history of psychotic disorder or is currently being treated or requires treatment for post-traumatic stress disorder, acute stress disorder, panic disorder, or obsessive compulsive disorder
• Has current evidence of an unstable neurological, cardiovascular, respiratory, gastrointestinal, renal, hepatic, hematologic, or other medical disorder, including cancer or malignancies that would affect the patient’s ability to participate in the program
• Has a known history or symptoms of long QT syndrome
• Is determined to be inappropriate for the study for any reason

Additional inclusion/exclusion criteria apply. Patients will be evaluated at screening to ensure that all criteria for study participation are met. Patients may be excluded from the study based on these assessments (and specifically, if it is determined that their baseline health and psychiatric condition do not meet all pre-specified entry criteria).

Will subjects be paid? Include amount and payment schedule.: 80 $ per visit

A person to contact, and a website for more general information:
Anastasiya Drovnyashina
Clinical Research Coordinator at Integrative Clinical Trials, LLC
Direct 718.444.7774 Ext: 117
Anastasiya.Drovnyashina@iclinicaltrials.net
www.iclinicaltrials.net

Post expires: 1 year

Looking for voluntary research participants who fit the following criteria:

• male or female between 18 and 50 years old
• diagnosed with schizophrenia or schizoaffective disorder
• on a stable dose of antipsychotic medication for at least 2 months prior to screening.

Cerevance (CVN058) is an experimental medication that effects the serotonin type 3 receptors in the brain that is being developed for the treatment of cognitive problems in patients with schizophrenia. To date, no specific treatments for cognitive deficits in schizophrenia exist and approved therapies do not satisfactorily improve cognition.

This study will measure naturally occurring brain waves to learn whether CVN058, an investigational drug, may have potential as a new treatment for schizophrenia. This study will also examine whether genetics affects how people respond to CVN058.

The purpose of this study is to determine whether the brain wave patterns are improved after administration of CVN058 compared to placebo in subjects with schizophrenia. The study uses electroencephalography (EEG) to measure naturally occurring brain waves as you listen to recorded sounds. These brain waves can indicate how the brain makes use of auditory information, such as deciding if two tones played one after another are the same or different. Besides MMN, other related brain wave patterns are measured.

Compensation: You will receive a compensation of $50 for the screening visit and $150 for completing each of the 3 treatment periods (that is, $450 for completing all 3 periods). If participating in the optional genetics substudy, you will receive an additional $50. The maximum total amount you may receive for the whole study will be $550. Reasonable and necessary expenses in connection with the study, such as on-site meals, travel and parking, will be reimbursed. A receipt may be required for reimbursement. You will be paid in cash or get a check by mail 4 to 6 weeks after the study.

Person to Contact: if you have questions or if you would like to participate in this study contact Melissa Conant at 646-774-8496 or melissa.conant@nyspi.columbia.edu.

When does the study expire?:  January 2020.

Looking for voluntary research participants who fit the following criteria:

• male or female between 18 and 60 years old
• diagnosed with schizophrenia or schizoaffective disorder
• having side effects or not doing well on current medications

This study plans to learn more about an investigational new drug called ITI-007 (lumateperone tosylate) and may help us to find new types of treatment for schizophrenia and schizoaffective disorder. “Investigational” means that the study drug (ITI-007) has not been approved by the U.S. Food and Drug Administration (FDA), and is considered experimental. There is no placebo (sugar pill) in this study, and everyone will receive ITI-007.

An urgent need exists for new treatments of schizophrenia that are effective against a broad range of symptoms and free of limiting safety issues. ITI-007 (Lumateperone tosylate)is an experimental medication that affects brain proteins that is being developed as a schizophrenia treatment. ITI-007 appeared to work similarly to an FDA approved medication for schizophrenia (risperidone) in a recently published study. The purpose of this study is to offer open label ITI-007 treatment to patients who either poorly respond or poorly tolerate approved medications. A discussion about clozapine will occur during the consent process.

There is no compensation for the study, however you can be reimbursed up to $50 per visit for study related expenses (e.g., travel, food, etc). You may be asked to provide receipts for reimbursement of expenses.

If you have questions or if you would like to participate in this study call 646-774-8496 or e-mail melissa.conant@nyspi.columbia.edu.

Data collection for this study began in March 2019 and is scheduled to end in March 2021.

The purpose of this study is to compare the effects of Mindfulness-Based Stress Reduction (MBSR) with Escitalopram (Lexapro) for treating anxiety disorders, specifically social anxiety disorder, generalized anxiety disorder, panic disorder, and agoraphobia. Participants are randomized into two 8-week treatments: (1) MBSR and (2) escitalopram.

MBSR intervention will include a weekly 2.5 hour class for 8 weeks. The intervention will also include a 1-day (7 hours) retreat on a weekend at the end of the program. Participants will also be asked to engage in 45 minutes of practice at home on a daily basis, as well as informal practice assignments that instruct participants to bring mindfulness to current daily activities.

Participants will receive free treatment no matter which arm they are assigned to. They will need to come to our offices in Midtown East Manhattan for a 3-hour screening visit, a 1-hour baseline visit, and 5-6 study assessment visits. There will also be follow-up visits at 3 months and 6 months.

Participants will receive $20 per study visit, not including screening. If participants complete the study, they will receive $160. We can also reimburse up to $10 in transportation costs for each visit.

For more information, please call 1-888-44-WORRY or email anxietystudy@nyumc.org. This study is run by NYU Langone Health.

This study is recruiting through October 2020.

This study is being conducted by researchers from the Temple University Collaborative on Community Inclusion. The goal of the study is to create guidelines to measure and improve Coordinated Specialty Care (CSC) for psychosis programs. The researchers are interested in how well CSC programs promote and support community participation. To gather this information, they need to hear from people who have been involved with the programs.

Study participants will join a national advisory group to meet via online video conference. Meetings will occur once to twice per month for a period of nine months. The total study period is twenty months. Participants will receive gift cards up to a total value of $600.

This study is seeking three “types” of participants: transition aged-youth, family member, and thought leader.

• Transition aged-youth: aged 18–30, has early psychosis, has been or is involved with a CSC program
• Family member: relative (e.g., parent, sibling, grandparent) or romantic partner of a transition aged-youth who has been or is involved with a CSC program
• Thought leader: program staff (e.g., psychiatrist, social worker, peer specialist), team leader, administrator, director, or trainer who the researchers consider an expert in CSC based on their contributions to the field

The study is seeking 20 total eligible participants.

If you have questions or if you would like to apply to participate in this study, please call the Temple University research staff at (215) 204-1699 or email tucollab@temple.edu.

This study is an online survey for people with mental health conditions and their family members and friends. The goal of the study is to learn more about how people with mental health conditions seek help and the ways that their family and friends may influence and support them. This research will help us understand what makes help-seeking easier or more difficult, allowing us to develop better resources for help-seekers in the future.

The survey has two sets of questions. One set is for people with a mental health condition, and the second set is for family members and friends of people with a mental health condition. Participants will be asked to select the set of questions that best applies to them. The survey takes 15-20 minutes to complete. Participants will have the option to submit the survey anonymously or to provide an email address. If you choose to provide your email address, you will be entered in a raffle to win an Amazon gift card. Contact information will not be stored or used for any purpose other than notifying raffle winners.

Study participants can access the survey using this link: http://elon.co1.qualtrics.com/jfe/form/SV_8cSGs47aJCBOCVv

Participants are eligible for this study if they:

• Are aged 18 and older
• Have a mental health condition, or are the family member or friend of a person with a mental health condition

Approximately 500 people are expected to complete this survey.

If you have questions or would like more information, you may contact the researchers directly. Jordan DeVries and Dr. CJ Fleming are researchers at Elon University in North Carolina and members of NAMI NC.

CJ Fleming can be reached at cfleming6@elon.edu.

Improving Cognition via Exercise in Schizophrenia

The goal of this study is to examine the impact of exercise training on cognition, daily functioning, and biomarkers of cognitive change in people diagnosed with schizophrenia and related disorders.

Following an initial research assessment, participants will be assigned by chance to participate in either aerobic exercise training or stretching-and-toning exercise training. Participants in both groups will take part in a 12-week, 3-times per week, 1-hour training program, in addition to their regular psychiatric and/or medical care. All training will be led by a certified trainer in a small group setting. Participants may continue to be treated by their current psychiatrist and/or other mental health clinicians during the study. 

Research assessments will be administered at baseline, and after 6- and 12-weeks of training.  These include diagnostic, clinical and cognitive assessments (interviews, questionnaires, cognitive tasks); fitness assessments and physical activity monitoring; and providing urine and blood samples.

Additional information is available about the study is available at: https://clinicaltrials.gov/ct2/show/NCT03270098?term=NCT03270098&rank=1

Data collection for the study began in May 2018 and is expected to last ~3 years.

Is the study therapeutic? – Yes.

Is the study funded? – Yes, the study is funded by a federal grant from the National Institute of Mental Health, Bethesda, MD (NIMH, Grant #: R01MH110623)

Would subjects be paid? – Eligible participants may receive up to $260 for the completion of the study procedures and research assessment. Participants will also receive reimbursement for travel expenses associated with attending the research assessments and the weekly exercise sessions. 

Contact Information – Interested participants should contact Dr. Luz Ospina, Study Director, at 212-585-4647 orluz.ospina@mssm.edu .

Post expires May 2021.

The primary objective of this study is to understand how brain anatomy relates to function and health. This study is funded by the National Institute of Mental Health and is conducted at New York University School of Medicine, Departments of Radiology and Psychiatry.

We are recruiting 18-30 year old participants who have been diagnosed with schizophrenia or bipolar disorder in the last five years. An initial telephone screening and clinical interview will establish eligibility for the study.

The study involves:

• Clinical assessment
• MRI scanning
• Blood draw
• Cognitive Assessment

This is a non-therapeutic study that does not involve treatment and does not interfere with any ongoing treatments. If eligibility criteria are met, a compensation of $160 will be provided at the completion of the study.

For more information please contact: mariana.lazar@nyumc.org or 212 263-3348.

There is no expiration date for the post at this time.

Do you have a loved one between the ages of 13-17 who has been diagnosed with Schizophrenia or has symptoms of Schizophrenia? Are you interested in joining a clinical research study that may increase our understanding of the disease?

This study is designed to evaluate the safety and efficacy of an investigational drug, called brexpiprazole, for adolescent patients diagnosed with Schizophrenia. The study will compare this medication with an active control (ABILIFY® (aripiprazole)) and placebo.

In order for your child to take part in the clinical research study, you will need to review the full checklist of criteria – found on the eligibility page. Some of the basic criteria that must be met are:

• Be 13-17 years old
• Have a diagnosis or symptoms of schizophrenia that has been confirmed by their doctor
• Do not have a diagnosis of autism, bipolar disorder, schizoaffective disorder, pervasive developmental disorder (PDD), OCD, or PTSD that has been the primary focus of treatment within 3 months of screening.
• Do not have a history of seizures, epilepsy, stroke, or head trauma.

Other requirements will be reviewed in detail with you by the Study Center staff, if your child meets the requirements above and attends a screening visit.

Click here to begin screening.

This study is looking at whether a medication called brexpiprazole is safe and effective in reducing the symptoms of major depressive disorder (MDD) when used together with other antidepressant therapies. The goal of this study is to increase treatment options for adults with MDD who have difficulty managing their symptoms with current antidepressant therapies.

Participants may be eligible for this study if they:

• Are 18-65 years old
• Have a current diagnosis of major depressive disorder (MDD), and are having difficulty managing symptoms
• Are taking one or two antidepressant therapies as recommended by a healthcare provider

There will be approximately 1,500 people participating in this study in the US.

This study will take place at approximately 75 clinic sites across the US. Please visit the study website to view clinic sites in your region.

If you have questions or would like more information, please refer to the study website: https://cli.re/6zEXxZ

Currently there are no medications that are approved for Tourette’s Syndrome in Children and Adolescents. Under the supervision of the FDA we are conducting Clinical Trials that involve the use of medications that are already on the market for a different indication.

Here are links with some more information about these trials:

https://clinicaltrials.gov/ct2/show/NCT03530293 for Ingrezza;

https://clinicaltrials.gov/ct2/show/NCT03567291 for Austedo

In order to participate, the patient has to be 6 – 16 years old and both parents and subjects must agree to participate. Patient must meet criteria for Tourette’s Syndrome, even if they have not been diagnosed with Tourette’s Syndrome. The Screening Visit is at no cost to the patient and includes a thorough/extensive physical and neurologic evaluation as well as ECG, Labs and rating scales to confirm the diagnosis of TS.

Transportation and a stipend are provided to the patient. If the subject qualifies for the protocol, a Baseline visit will be scheduled prior to random assignment to one of the treatment groups. At least one parent must accompany the subject at all visits.

Children who participate in the study will receive either the investigation medication or placebo (inactive substance), study-related medical exams, and study-related laboratory services at no charge. Dr. Faedda and research site staff will closely monitor study participants and the information collected. This may lead to future options for managing TS.

For more general information visit the Mood Disorders Center website at https://mdcnyc.com.

To participate and for more information: Contact Yao Ma, Recruiting Specialist Recruitment@mdcnyc.com

Post expires one year, or longer.

Research has shown that genes can make some people more likely than others to develop OCD or Related Disorders. The goal of our study is to identify these genes.

ELIGIBILITY:

• 7 years old or older
• Have symptoms or a diagnosis of Obsessive Compulsive Disorder and Related Disorders (Hoarding Disorder, Body Dysmorphic Disorder, Hair Pulling Disorder/Trichotillomania, and Skin Picking Disorder/Excoriation Disorder)

STUDY PROCEDURES:

• Complete a screening questionnaire on personal and family health history
• Be interviewed by a clinician about your symptoms
• Give a small blood sample (about 3 tablespoons)
• Be compensated for your time and effort
• This is a one-time participation, no follow-up required. Subjects will be paid $50.

Contact Information: Institute for Genomic Health

• InstituteforGenomicHealth@downstate.edu
• 718-270-8254

More information: https://www.downstate.edu/psychiatry/research/index.html
Post expires 7/6/2019

Research has shown that genes can make some people more likely than others to develop Schizophrenia or Bipolar Disorder. The goal of our study is to identify these genes.

ELIGIBILITY:

• 18 years old or older
• Diagnosis of Schizophrenia or Bipolar Disorder

STUDY PROCEDURES:

• Complete a screening questionnaire on personal and family health history
• Be interviewed by a clinician about your symptoms
• Give a small blood sample (about 3 tablespoons)
• Be compensated for your time and effort
• This is a one-time participation, no follow-up required. Subjects will be paid $50.

Contact Information: Institute for Genomic Health

• InstituteforGenomicHealth@downstate.edu
• 718-270-8254

More information: https://www.downstate.edu/psychiatry/research/index.html
Post expires 7/6/2019

The purpose of this study is to investigate the relationship between aging processes and PTSD, which may help identify novel therapeutic targets to promote healthier aging trajectories for PTSD patients. Chronic PTSD increases mortality risk from medical diseases, promotes aging-associated syndromes such as frailty, and is linked to faster cognitive decline in older adults. One strong possibility is that PTSD leads to these adverse health outcomes by accelerating biological aging in the brain and body.

Participants will be asked to attend a total of 3 visits consisting of: an evaluation, an MRI, and a day of neuropsychological testing.

To compensate for the time required for the eligibility evaluation, we offer $50 cash upon completion. Additionally, you will be paid $300 if you complete all procedures in this study, including the two additional study visits. Payment will take place in the form of a check.

To participate and for more information: Contact Chloe Salzman at 646-774-8655

The purpose of this study is to determine whether treating hearing loss is helpful for depression over and above the known effects of antidepressants. Age-related hearing loss (ARHL) is the third most common health condition affecting older adults after heart disease and arthritis and is the fifth leading cause of years lived with disability worldwide. Many hearing-impaired older adults avoid or withdraw from social contexts in which background noise will make it difficult to communicate, resulting in social isolation and reduced communication with family and friends. Social isolation and loneliness have been linked to numerous adverse physical and mental health outcomes, including dementia, depression, and mortality, and they may also lead to declining physical activity and the development of the syndrome of frailty.

In this research study, participants may be fitted with free hearing aids. They will also receive treatment for depression with an FDA approved medication called escitalopram (Lexapro) or duloxetine (Cymbalta). Escitalopram is a Selective Serotonin Reuptake Inhibitor (SSRI) medication, and duloxetine is a Selective Serotonin-Norepinephrine Reuptake Inhibitor (SSNRI) that both appear to help with symptoms of depression. Participants will attend study visits to monitor progress and ensure safety over the course of participation. Participants may also be offered brain scans using magnetic resonance imaging (MRI).

• To participate, individuals must be 60 years or older.
• We offer $50 for the completion of each MRI scan. We also offer reasonable compensation for travel costs related to study participation. Participants may also receive free hearing aids listed at a price of $6,000.
• To participate and for more information: Contact Alexandra Stein at 646-774-8672

In this research study, participants may receive treatment for depression with an FDA approved medication called escitalopram (Lexapro) or placebo. Escitalopram is a Selective Serotonin Reuptake Inhibitor (SSRI) medication that appears to help with symptoms of depression by increasing the availability of specific chemicals in the brain. A placebo is a sugar pill. This study is looking at treatment response in adults ages 18-75. Participants will attend study visits and receive phone calls from staff to monitor progress and ensure safety over the course of participation.

• Subjects may receive up to $300 in compensation over the course of participation.
• To participate and for more information: Contact Stuart Fine at 646-774-8670

Individuals with Late Life Depression (LLD) often have problems with memory, attention, and problem solving, all of which contribute to antidepressant non-response. Available evidence suggests that declining functionality in the brain’s dopamine system contributes to age-related cognitive and motor slowing. The purpose of this research study is to test whether a medication called carbidopa/levodopa (Sinemet) is helpful for the treatment of depression in older adults. Carbidopa/levodopa is approved by the Food and Drug Administration for the treatment of Parkinson’s Disease. We are using carbidopa/levodopa in this study to see whether it is capable of improving depressive symptoms as well as mental and physical slowing that occur as people age.

• Participants will be prescribed carbidopa/levodopa (Sinemet) by the study psychiatrist, free of charge. Progress will be monitored through weekly visits with the study staff for 8 weeks. Participants may also be offered brain scans using magnetic resonance imaging (MRI) and positron emission tomography (PET).
• To participate, individuals must be 60 years or older.
• Contact Emily Valente at 646-774-6704 for more information or to sign up.

Treatment-resistant depression (TRD) is a major health problem for the growing population of older adults. Unfortunately, there is a lack of evidence-based treatments that establish the benefits vs. risk of medication in this patient population. The purpose of this research study is to find out which antidepressants work best in individuals over the age of 60 who did not respond or were intolerant to at least two antidepressant medications. The study offers treatment with FDA approved medications: aripiprazole, bupropion, lithium, and nortriptyline.

• Participants will be prescribed medication by the study psychiatrist. Progress will be monitored through biweekly phone calls or visits with the study staff. Participants will be asked to complete neuropsychological assessments, answer questions about their mood, and report medication tolerance.
• To participate, individuals must be 60 years or older.
• Subjects are paid $50 for completing initial evaluation. If found eligible and enrolled into the study, subjects receive $75 at the baseline visit, $75 at the end of 10-weeks of treatment, and $25 at each of 3 follow up visits after completing the initial 10 weeks of acute treatment.
• For more information: Stephanie Gomez at 646-774-8698 or Sandra Sanchez for service in Spanish at 646-774-8692
• Read more here: www.optimumstudy.org/for-participants.html
• This study will continue to recruit for the next 3 years.

Depression affects up to 20% of the population in a given year. We’re asking patients to provide a short speech sample and complete a survey (e.g. a modified PHQ-9 score) so we can determine whether an individual is depressed from acoustic and linguistic features. By being a part of the study as a patient or a control, you will help us build better algorithms to detect depression symptoms from voice samples.

Patients can participate on laptops, tablets, or mobile devices: https://mha.neurolex.ai. You can also try a demo: http://collect.neurolex.ai.

By analyzing short voice samples for unique health characteristics, our technology discovers specific speech variations that indicate different health abnormalities earlier than previously possible. These new, proprietary tools give patients and providers greater visibility into their overall well-being, enabling early action to prevent symptoms from worsening.

At NeuroLex we are empowering patients with tools to measure their overall health through collecting and analyzing speech samples. By fingerprinting health abnormalities early, we equip patients and physicians with insight to prevent symptoms from worsening. In this way, we strive to be the world’s leading platform company to advance linguistics as a tool to characterize psychiatric and neurological health conditions.

Is the study therapeutic (offering treatment)? Non-therapeutic

Is the study funded? This research study is funded internally by NeuroLex Laboratories, a for-profit company. There are no disclosed ties to the pharmaceutical industry. We are actively pursuing government grants like SBIRs to further our work.

Who will be conducting the study? NeuroLex is conducting the study in close collaboration with several academic partners.

Go to NeuroLex to read more about the company and the technology.

The Schizophrenia Research Program at NYU Langone Health, is currently seeking individuals (ages 16-30) with a diagnosis of schizophrenia, schizotypal, or schizophreniform disorder who have not taken antipsychotic medication for at least 4 weeks to participate in our research study funded by the National Institute of Mental Health.

In our study, we are looking for an alternative treatment for individuals with early psychosis. We are trying to see if a single dose of an anticonvulsant medication may be able to quiet down a specific part of the brain.

The study involves:

• Two study visits
• Two brain imaging scans
• One single dose of Keppra (an FDA approved anticonvulsant medication) or placebo.

If eligibility criteria are met, participants will receive $200 for the completion of the study in addition to reimbursement for travel. If you are interested in participating or want more information please call or text our study team at (917) 565-1581 or email us at GoffLab@nyumc.org.

This study is looking at whether an investigational medication called BI 409306 is safe and effective in reducing the early symptoms of psychosis. The goal of this study is to increase treatment options available for people experiencing the early symptoms of psychosis.

Participants may be eligible for this study if they are:

• 16-30 years old
• Experiencing early symptoms of psychosis
• Have not yet experienced a first episode of psychosis

If you have questions or would like more information, please refer to the trial website (https://1289-0032study.com)

This study is an anonymous online survey that looks at tobacco use by people who experience mental health conditions. The goal of this study is to give researchers more information about how many people in this population use tobacco, how many would like to quit using tobacco, and some of the important experiences and feelings involved. Collecting this information is very important to support future research in tobacco cessation.

Participants may be eligible for this study if they:

• Are 18 years or older
• Have been diagnosed with a mental health condition

Please select this link to access the survey: https://uofmississippi.qualtrics.com/jfe/form/SV_0cuRZjHQUM5BZLD

If you have questions about this study, you may contact the research team directly. Dr. Joshua Mann can be reached at jmann4@umc.edu.

We are a behavioral health startup based in New York City.  We are currently developing a self-directed cognitive behavioral therapy app for iOS and Android devices to help individuals better manage their stress, anxiety, and mood.  The app consists of a six-week interactive curriculum written by clinical psychologists.  Through educational material and homework assignments, the app teaches users to differentiate between their thoughts and feelings, and to develop healthy self-care behaviors.

We are currently conducting a consumer-focused product research and are looking for participants to take part in a focus group which would give participants the opportunity to play around with the app and provide feedback.

Participation in our research consists of an in-person interview at a WeWork office in New York City during the month of September.  The interview will take no longer than 60 minutes and participants will be compensated.

To participate individuals must:

• Be 18 years or older
• Have a smartphone
• Have, or have had private health insurance
• And be interested in managing their mood, reducing stress, or increasing their happiness

To see if you qualify, please take this survey: https://digitalhealth1.typeform.com/to/XPSJBW.

For questions, email research.digital.health@gmail.com.

To date, very little is known about client and family experiences following discharge from specialized first episode psychosis/early intervention programs (like OnTrack) or how to best support them. This study aims to better understand what happens after discharge from OnTrack, including in the areas of school or work involvement and access to/use of other mental health services.

Who Is Eligible: Any family member of a former OnTrack client who has been discharged at least one year prior to a scheduled interview is eligible. Former clients will be recruited for the project through the OnTrack sites at which they initially received services.

Study Activity & Time Involved: If interested, you would be asked to participate in an approximately 1.5 hour long oral interview by phone or in person. This is not a treatment study.

Compensation: You will be compensated $75 for your time.

Who to Contact: To ask any questions or get involved, please contact Dr. Jones directly at 773-639-8360 or by email at genevra@usf.edu.

In this study, local doctors are evaluating an investigational drug that is being developed for the treatment of manic episodes. They want to compare the investigational drug to placebo, which looks like the investigational drug, but contains no active medication

The investigational drug is currently approved in Canada and the United States for the treatment of schizophrenia. It is also approved in the United States as an added treatment to antidepressants for major depressive disorder. It has not been approved anywhere to treat manic episodes related to bipolar disorder. The results of this study will help provide more information about the investigational drug and whether it could one day be used as a treatment for manic episodes.

Who is eligible to participate in this study? To pre-qualify for this study, you must:

• Be 18 to 65 years of age
• Have been diagnosed with bipolar I disorder
• Be having symptoms of a manic episode

All study-related visits, tests, and drugs will be provided at no cost. In addition, reimbursement for study-related travel may be provided.

To see if you are eligible for this study, please click here: leapcurebipolardisorder.studies.leapcure.com

A Double-Blind, Placebo-Controlled Study of Brexpiprazole plus Ketamine in Treatment-Resistant Depression (TRD)

Montefiore Medical Center is seeking patients with major depressive disorder (MDD) between the ages of 18 and 65 to participate in a new depression research study.

Dr. Jonathan Alpert is conducting this research to assess if the combination of brexpiprazole and intranasal ketamine can safely and effectively treat depression symptoms when added to stable, ongoing antidepressant treatment.  Ketamine is approved by the U.S. Food and Drug Administration (FDA) to be used with other drugs for anesthesia and as a pain reliever during procedures.  However, ketamine is not approved by the FDA to treat depression.  Brexpiprazole (Rexulti) is approved by the U.S. Food and Drug Administration (FDA) as an add-on treatment to an antidepressant medication to treat adults with major depressive disorder (MDD).  Participants will receive either the active study medication (1/2 chance of receiving brexiprazole) plus 40 mg of ketamine administered intranasally ,  or placebo (1/2 chance of receiving placebo) plus 40 mg of ketamine administered intranasally.  Participants will be monitored by an experienced study physician.  The study requires 12 visits to our research clinic over a period of 5 to 8 weeks, depending on the length of the screening portion.

Participants will receive compensation for their time.  You will be paid $450 if you complete the study.  If you do not complete the study, you will be paid for each visit you complete.

Please contact Jennifer Alexander if you or someone you know is interested in learning more about this study.

Jennifer Alexander
929-429-5644
jealexan@montefiore.org

Does your child struggle to stay organized?

Many children with conditions like Attention-Deficit/Hyperactivity Disorder (ADHD) struggle to stay organized, manage their time, and plan activities. Even when ADHD is being well treated, organizational problems can cause difficulties in school and create headaches at home.

Children in grades 3-5 (who have one main teacher) are being recruited for a therapeutic study on brain function at the NYU Child Study Center funded by the National Institute of Mental Health.

Children must show difficulty with organization, time management or planning.

The study will include

• a brief no-cost assessment
• two brain MRI scans at NYU
• a no-cost weekly individualized treatment for 12 weeks

Participants will be compensated $75 for the initial evaluation and $75 for each of the two MRI scan sessions.

For more information, please contact us at (646) 754-5147 or csc.organizedkids@nyumc.org, or visit our website: bit.ly/organized-kids.