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The Nathan S. Kline Institute for Psychiatric Research

Research Studies & Clinical Trials

Current Trials and Research Opportunities Include:

Alzheimer's Disease

ADNI 4 (Alzheimer’s Disease Neuroimaging Initiative)

This study is sponsored by the NIH and will employ cutting-edge techniques to evaluate normal and pathological brain aging which could help change the future of Alzheimer’s disease. Poor memory is often viewed as a simple sign of getting older, complicating our understanding and treatment of Alzheimer's disease. For more than a decade, ADNI researchers have worked tirelessly to better understand the disease and its progression in a way that will help the development of future treatment options, though no experimental medication will be involved in this study.

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Title

ADNI 4 (Alzheimer’s Disease Neuroimaging Initiative)

Description

This study is sponsored by the NIH and will employ cutting-edge techniques to evaluate normal and pathological brain aging which could help change the future of Alzheimer’s disease. Poor memory is often viewed as a simple sign of getting older, complicating our understanding and treatment of Alzheimer's disease. For more than a decade, ADNI researchers have worked tirelessly to better understand the disease and its progression in a way that will help the development of future treatment options, though no experimental medication will be involved in this study.

Study Length
The study is set to run up to 5 years depending on funding.
Inclusion Criteria

The study is open to both male and female subjects, aged 55-90 years.

Open to all ranges of cognitive function:

  • cognitively normal
  • Mild Cognitive Impairment (MCI)
  • Mild dementia due to Alzheimer’s
Contact

Antero Sarreal, MD at 845-398-6532 or asarreal@nki.rfmh.org.

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Alzheimer's disease; Memory evaluation

The Memory Education and Research Initiative (MERI Program)

The MERI program offers a comprehensive memory and cognitive evaluation at no cost, to individuals with memory complaints or a family history of Alzheimer’s disease (AD).

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Title

The Memory Education and Research Initiative (MERI Program)

Description

Goals:

  • To communicate the results of these evaluations to participants and their personal physicians, if requested
  • To allow a baseline cognitive performance to be established for healthy individuals with no memory complaints but with a family history of AD or other dementias
  • To alert community health professionals about ongoing clinical studies for the treatment of memory disorders
  • To bring advances in basic research of Alzheimer’s disease and related disorders to clinical research studies
  • To educate participants about healthy brain aging

The MERI visit: The initial evaluation is usually completed in 1 visit, and lasts approximately 3 hours. Patients are encouraged to bring a family member or caregiver to the appointment.

Benefits of the MERI: Upon completion of the evaluation, all assessments will be scored and entered into a secure database. Results will be discussed among the doctors and psychologists of our team. A summary of this evaluation will be mailed out to you (and/or your physician if you so wish) in approximately 2-3 weeks. This report will contain findings about your general intellectual function, memory, and psychomotor function, as well as brief comments and recommendations.

Contact

To learn more about the MERI Program, visit our website: http://geri.rfmh.org, or call 845-398-5584.

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Alzheimer’s Disease / Mild Cognitive Impairment

Transcranial photobiomodulation for mild cognitive impairment/Alzheimer's Disease (TRAP-AD)

Are you experiencing memory problems? If you are 65+, you may qualify to participate in our study investigating an experimental treatment device for memory problems using near-infrared light therapy at the Nathan Kline Institute! Compensation will be provided for time and transportation.

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Title

Transcranial photobiomodulation for mild cognitive impairment/Alzheimer's Disease (TRAP-AD)

Description

Are you experiencing memory problems? If you are 65+, you may qualify to participate in our study investigating an experimental treatment device for memory problems using near-infrared light therapy at the Nathan Kline Institute! Compensation will be provided for time and transportation.

Study Length
4-6 months
Study Location
Nathan Kline Institute (NKI)
Inclusion Criteria
  • Have memory problems
  • Willing to travel to NKI
Contact

Zamfira Parincu, 845-398-6571 or zamfira.parincu@nki.rfmh.org

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Autism Spectrum Disorder

A Randomized, Double-blind, Parallel Group, Placebo-Controlled Study to Investigate the Efficacy, Safety, and Tolerability of ML-004 in Adolescents and Adults with Autism Spectrum Disorders (ASD)

The primary objective of this study is to evaluate the effectiveness and safety of ML-004-002, a new investigational medication, compared with placebo in improving social communication in autistic individuals.

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Title

A Randomized, Double-blind, Parallel Group, Placebo-Controlled Study to Investigate the Efficacy, Safety, and Tolerability of ML-004 in Adolescents and Adults with Autism Spectrum Disorders (ASD)

Description

The primary objective of this study is to evaluate the effectiveness and safety of ML-004-002, a new investigational medication, compared with placebo in improving social communication in autistic individuals.

Study Length
Approximately 6 months
Study Location
Nathan Kline Institute (Orangeburg, NY)
Inclusion Criteria
  • 18-45 years old
  • Diagnosis of autism spectrum disorder (ASD)
Exclusion Criteria
  • Current use of selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), and/or tricyclic antidepressants (TCAs)
  • History of migraines
Contact

Lucia Tu at Lucia.Tu@NKI.rfmh.org or (845) 398-6620

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Depression

Heterogeneity in OCD and Depression

This project aims to comprehensively characterize heterogeneity in Obsessive-Compulsive Disorder (OCD) and Major Depressive Disorder (MDD) in order to identify behavioral and neural markers that can be used as targets for future treatments.

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Title

Heterogeneity in OCD and Depression

Description

This project aims to comprehensively characterize heterogeneity in Obsessive-Compulsive Disorder (OCD) and Major Depressive Disorder (MDD) in order to identify behavioral and neural markers that can be used as targets for future treatments.

Study Length
3 visits: The first taking 3-4 hours, the second taking 1-2 hours, and the third taking 3-5 hours. The total number of hours will be approximately 7-11 hours.
Study Location
Nathan Kline Institute, Orangeburg, NY and New York University Medical Center, NY, NY
Inclusion Criteria

Men and women between the ages of 18-55 years old who have obsessive-compulsive disorder or major depressive disorder. Participants should be in good general health.

Contact

Nicolette Recchia at 845-398-5590 or pnclab@nki.rfmh.org.

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The ABD Study

The purpose of this research study is to test if a reduction in depressive symptoms in response to treatment with an antidepressant improves levels of certain proteins which have been associated with increased risk for the development of Alzheimer's disease (AD).

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Title

Depression treatment and Aß dynamics: A study of Alzheimer’s disease risk (ABD Study)

Description

The purpose of this research study is to test if a reduction in depressive symptoms in response to treatment with an antidepressant improves levels of certain proteins which have been associated with increased risk for the development of Alzheimer's disease (AD).

Study Length
Approximately 2 months for screening and 8 weeks for treatment.
Study Location
Nathan Kline Institute and NYU Grossman School of Medicine
Inclusion Criteria

You may be eligible for our study if you:

  • Are 60 or older
  • Are diagnosed with depression or have symptoms of depression
  • Feel comfortable completing an MRI
  • Are willing to be treated with Escitalopram (Lexapro) a widely prescribed antidepressant
  • Are willing to have a lumbar puncture procedure
Contact

For questions and concerns regarding any of this information, contact Dr. Antero Sarreal, Study Coordinator, 845-398-6532 or asarreal@nki.rfmh.org

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Depression - Major Depressive Disorder

Biobehavioral Predictors of Illness Progression in Adolescent Depression

Looking for paid research study participants. The participant and a parent will go through a free clinical evaluation with a clinician (remotely or in-person). The participant will have a blood draw and MRI scan. Your child will be compensated for the blood draw and scan and can win up to $60 in a game played in the scanner (totaling about $400).

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Title

Biobehavioral Predictors of Illness Progression in Adolescent Depression

Description

Looking for paid research study participants. The participant and a parent will go through a free clinical evaluation with a clinician (remotely or in-person). The participant will have a blood draw and MRI scan. Your child will be compensated for the blood draw and scan and can win up to $60 in a game played in the scanner (totaling about $400).

Study Location
Virtual for the clinical visit and in-person at Mount Sinai Hospital for the MRI scan visit.
Inclusion Criteria
  • Teens aged 12-18 years old.
  • Not taking any psychotropic medications
Exclusion Criteria
  • Active suicidal ideation requiring immediate clinical attention or hospitalization.
  • MRI contraindications including pregnancy
  • A positive urine toxicology test for substances besides marijuana/cannabis.
  • Immune-affecting medications or herbal supplements taken in the past two weeks.
  • Any neurological and medical illnesses like epilepsy
  • Psychotropic medication use or neuro-active medications including anti-seizure and over the counter medications within the past month.
  • Current psychotic symptoms.
  • Autism Spectrum Disorder (ASD).
  • Substance-related disorders besides cannabis.
Contact

Chloe Roske, gabbay.lab@einsteinmed.edu, 516-847-2019

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Depression - Major Depressive Disorder (MDD)

Transcranial Near Infrared Radiation and Cerebral Blood Flow in Depression (TRIADE)

Do you have depression? Are you interested in experimental treatments for depression and contributing to depression research? If so, you may qualify to participate in our research study at NKI, IRB Study # i20-00217, that is investigating an experimental treatment device for depression using near-infrared light therapy.

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Title

Transcranial Near Infrared Radiation and Cerebral Blood Flow in Depression (TRIADE)

Description

Do you have depression? Are you interested in experimental treatments for depression and contributing to depression research? If so, you may qualify to participate in our research study at NKI, IRB Study # i20-00217, that is investigating an experimental treatment device for depression using near-infrared light therapy.

Study Length
6-12 weeks
Inclusion Criteria

18-65 years old

Contact

Zamfira Parincu at 845-398-6571 or Zamfira.Parincu@nki.rfmh.org

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Obsessive Compulsive Disorder (OCD)

Heterogeneity in OCD and Depression

This project aims to comprehensively characterize heterogeneity in Obsessive-Compulsive Disorder (OCD) and Major Depressive Disorder (MDD) in order to identify behavioral and neural markers that can be used as targets for future treatments.

X
Title

Heterogeneity in OCD and Depression

Description

This project aims to comprehensively characterize heterogeneity in Obsessive-Compulsive Disorder (OCD) and Major Depressive Disorder (MDD) in order to identify behavioral and neural markers that can be used as targets for future treatments.

Study Length
3 visits: The first taking 3-4 hours, the second taking 1-2 hours, and the third taking 3-5 hours. The total number of hours will be approximately 7-11 hours.
Study Location
Nathan Kline Institute, Orangeburg, NY and New York University Medical Center, NY, NY
Inclusion Criteria

Men and women between the ages of 18-55 years old who have obsessive-compulsive disorder or major depressive disorder. Participants should be in good general health.

Contact

Nicolette Recchia at 845-398-5590 or pnclab@nki.rfmh.org.

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Obsessive-Compulsive Disorder (OCD)

Neural Mechanism of Active Avoidance in Obsessive-Compulsive Disorder

We are looking for individuals with Obsessive-Compulsive Disorder (OCD) for our study at the Nathan Kline Institute! The purpose of this study is to look at clinical symptoms, behavior, and brain function in the disorder.

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Title

Neural Mechanism of Active Avoidance in Obsessive-Compulsive Disorder

Description

We are looking for individuals with Obsessive-Compulsive Disorder (OCD) for our study at the Nathan Kline Institute! The purpose of this study is to look at clinical symptoms, behavior, and brain function in the disorder.

Study Length
Total participation time is 4 to 10 hours over 1 to 3 visits (some may be done remotely).
Study Location
Nathan Kline Institute, Orangeburg, NY
Inclusion Criteria

Men and women between the ages of 18-55 years old who have obsessive-compulsive disorder. Participants should be medically healthy. 

Contact

Jeanmarie Harvey at 845-398-6525 or email us at pnclab@nki.rfmh.org.

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Paid Research Study for OCD at The Nathan Kline Institute

We are looking for individuals with Obsessive-Compulsive Disorder (OCD) for our study at the Nathan Kline Institute! This study investigates the effects of transcranial magnetic stimulation (TMS) on brain function in patients with Obsessive-Compulsive Disorder (OCD).  

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Title

Paid Research Study for OCD at The Nathan Kline Institute

Description

We are looking for individuals with Obsessive-Compulsive Disorder (OCD) for our study at the Nathan Kline Institute! This study investigates the effects of transcranial magnetic stimulation (TMS) on brain function in patients with Obsessive-Compulsive Disorder (OCD).  

You must: 

  • Be 18-60 years old 
  • Be medically healthy 
  • Have OCD 

If eligible: 

  • Participation involves 1 remote screening appointment and 3 in-person appointments to NKI  
  • We will ask you about your health and to fill out some questionnaires about your symptoms 
  • During each in-person appointment, you will perform a computer task while having your brain activity measured using functional magnetic resonance imaging (fMRI; lasting under an hour), and receive a brief administration of transcranial magnetic stimulation (TMS; lasting under a minute) on the 2nd and 3rd in-person appointments 
  • Total time commitment is approximately 11 to 16 hours 
  • You will be reimbursed for your participation at a rate of 25 dollars per hour 
  • We will provide round-trip transportation between NKI and the NYC area  

Total participation time is between 11 to 16 hours and pays at a rate of $25 per hour. 

If you want us to contact you to tell you more about the study, please fill out our study interest form: https://redcap.link/TMSstudy 

For more information, call the Psychiatric Neurocognition Laboratory at 845-398-5590, email us at pnclab@nki.rfmh.org or visit us at psychneurocoglab.com. Please do not disclose any personal or sensitive information via email. 

Study Length
Total participation time is between 11 to 16 hours and pays at a rate of $25 per hour.
Study Location
Nathan Kline Institute, Orangeburg, NY
Inclusion Criteria

You must: 

  • Be 18-60 years old 
  • Be medically healthy 
  • Have OCD 
Contact

For more information, call the Psychiatric Neurocognition Laboratory at 845-398-5590, email us at pnclab@nki.rfmh.org, or visit us at psychneurocoglab.com.

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Schizophrenia

Clozapine for the Prevention of Violence in Schizophrenia: A Randomized Clinical Trial

Two-hundred and eighty individuals with schizophrenia who have a recent history of violent acts will be randomized in this 2-arm, parallel-group, 24-week, open-label, 7-site clinical trial to examine the effects of treatment with clozapine vs. antipsychotic treatment as usual (TAU) for reducing the risk of violent acts in real-world settings.

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Title

Clozapine for the Prevention of Violence in Schizophrenia: A Randomized Clinical Trial

Description

Two-hundred and eighty individuals with schizophrenia who have a recent history of violent acts will be randomized in this 2-arm, parallel-group, 24-week, open-label, 7-site clinical trial to examine the effects of treatment with clozapine vs. antipsychotic treatment as usual (TAU) for reducing the risk of violent acts in real-world settings.

Study Length
24 weeks
Study Location
Manhattan Psychiatric Center, 102 Rivers Edge Road, New York, NY 10035 AND Manhattan Psychiatric Center Outpatient Clinic, 163 West 125th Street, New York, NY 10027
Inclusion Criteria
  • DSM-5 diagnosis of schizophrenia or schizoaffective disorder
  • Committed a minor or serious act of violence as measured by the MCVI in the last six months
  • 18 to 65 years old
  • Appropriate for treatment with either clozapine or TAU
Exclusion Criteria
  • An unstable or serious medical or neurological condition
  • A history of intolerance/allergy to clozapine
  • A history of intellectual impairment
  • Pregnant or lactating women; women who are able to become pregnant but who are not willing to use effective methods of birth control.
Contact

For more information about this study, please contact Seth Eaton, research coordinator, at 646-766-5864 or Seth.Eaton@omh.ny.gov.

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Computerized facial and acoustic analysis during speech as a measurement of negative symptoms in schizophrenia

Dr. Anzalee Khan’s team is investigating an artificial intelligence (AI) enabled vocal and facial analysis, avatar driven software (called Neurological and Mental health Screening Instrument or NEMSI) to show good reliability and validity compared to existing clinician-administered psychiatric interview assessments, like: the Brief Negative Symptom Scale (BNSS), Positive and Negative Syndrome Scale (PANSS) Marder Negative Factor, and the Calgary Depression Scale (CDSS).

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Title

Computerized facial and acoustic analysis during speech as a measurement of negative symptoms in schizophrenia

Description

Dr. Anzalee Khan’s team is investigating an artificial intelligence (AI) enabled vocal and facial analysis, avatar driven software (called Neurological and Mental health Screening Instrument or NEMSI) to show good reliability and validity compared to existing clinician-administered psychiatric interview assessments, like: the Brief Negative Symptom Scale (BNSS), Positive and Negative Syndrome Scale (PANSS) Marder Negative Factor, and the Calgary Depression Scale (CDSS).

Study Length
One week
Study Location
Manhattan Psychiatric Center, Ward's Island Complex, NY
Inclusion Criteria
  • Inpatients with DSM-5 diagnosis of schizophrenia
  • English-speaking
  • WRAT-4 reading ≥ 8th grade level
  • 18-60 years of age
  • Have negative symptoms: which includes diminished vocal expression, decreased or increased vocal production, and difference in intonations when speaking                                                                                                                                                                                                                                                                                                                                                                                          
Exclusion Criteria
  • Have another DSM-5 diagnosis such as schizoaffective disorder, bipolar disorder, major depressive disorder, or tardive dyskinesia that is moderate to severe or requires treatment
  • Significant medical and/or major neurologic disorder
  • Clinically relevant abnormal movement disorders
Contact

For more information about this study, please contact Danyah Nadim, MD, research coordinator, at 646-672-6767 or Danyah.Nadim@omh.ny.gov.

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JOURNEY STUDY: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Valbenazine as Adjunctive Treatment in Subjects with Schizophrenia

The purpose of this Journey Study is to find out how safe the study drug, called valbenazine, is, how well the body handles taking it (tolerability), and how well it works as an add-on therapy in study participants with schizophrenia who did not respond well enough to antipsychotic therapy. This study aims to find out how well the study drug works compared to a placebo as an add-on therapy in participants who still experience symptoms. Placebos are made of a substance that looks just like the study drug being tested, but they contain no active ingredients. The first dose of study treatment will occur when subjects are enrolled (up to 4 weeks after the screening visit), and the follow-up period will be approximately 2 weeks following a participant’s final dose.

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Title

JOURNEY STUDY - "A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Valbenazine as Adjunctive Treatment in Subjects with Schizophrenia” NBI-98854-ATS3019

Description

The purpose of this Journey Study is to find out how safe the study drug, called valbenazine, is, how well the body handles taking it (tolerability), and how well it works as an add-on therapy in study participants with schizophrenia who did not respond well enough to antipsychotic therapy. This study aims to find out how well the study drug works compared to a placebo as an add-on therapy in participants who still experience symptoms. Placebos are made of a substance that looks just like the study drug being tested, but they contain no active ingredients. The first dose of study treatment will occur when subjects are enrolled (up to 4 weeks after the screening visit), and the follow-up period will be approximately 2 weeks following a participant’s final dose.

Study Length
The study will last for approximately 16 weeks (4-week screening period, 10-week study treatment period, 2-week washout/follow-up period) with 7 study visits.
Study Location
Manhattan Psychiatric Center’s 125th Street Clinic, 163 West 125th Street, 11th and 12th Floors, NY, NY 10027
Inclusion Criteria
  • Be male or female aged ≥ 18 years old
  • Be diagnosed with schizophrenia for at least 1 year prior to the start of the research study
  • Be receiving a daily dose of antipsychotic therapy (other than clozapine)
  • Have a history of not responding well to antipsychotic treatment
Contact

For more information about this study, please contact Benedicto Parker at 212-961-8992 or benedicto.parker@nki.rfmh.org,

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Schizophrenia or Schizoaffective Disorder

A pilot study examining integrated virtual reality avatar CBT for treatment refractory auditory hallucinations in individuals with schizophrenia

The aim of the study is to assess the efficacy of integrated virtual reality avatar CBT for improvements in persistent and treatment refractory auditory hallucinations in individuals with psychosis.

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Title

A pilot study examining integrated virtual reality avatar CBT for treatment refractory auditory hallucinations in individuals with schizophrenia

Description

The aim of the study is to assess the efficacy of integrated virtual reality avatar CBT for improvements in persistent and treatment refractory auditory hallucinations in individuals with psychosis.

Study Length
6 weeks therapy with week 10 as follow-up
Study Location
Manhattan Psychiatric Center (MPC); Weill Cornell Medical Center Westchester Division (WCMC)
Inclusion Criteria
  • Ages ≥ 18 to ≤ 60
  • Schizophrenia or schizoaffective disorder diagnosis
  • Inpatients in a psychiatric hospital 
  • Auditory hallucinations for at least 3 months at least more than once per week with moderate amount of disturbance.
  • No changes in antipsychotic treatment for 2 weeks prior to enrollment.
  • Participants must have a score at Screening on the PANSS item P3 (Hallucinatory Behavior) of ≥ 4.
Exclusion Criteria
  • Unable to identify a single dominant “voice” of their auditory hallucinations.
  • Participants who answer “Yes” on the C-SSRS Suicidal Ideation or Behavior within the last 6 months of Screening.
  • Unwilling or unable, in the opinion of the Investigator, to comply with study instructions.
Contact

Study coordinator: Ibrahim Bukhari, ibrahim.bukhari@omh.ny.gov, 646-766-5875; Principle Investigator: Jean-Pierre Lindenmayer, MD, jean-pierre.lindenmayer@nki.rfmh.org; Principle Investigator: Anzalee Khan, PhD, anzalee.khan@nki.rfmh.org

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Schizophrenia Registry

The purpose of this project is to create a database, which will allow us to contact participants for active studies as well as other research opportunities within our program.

This database registry project is designed to give an opportunity to interested patients with schizophrenia or schizoaffective disorder to have access to the various research studies that the MPC Research Program has available.

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Title

Schizophrenia Registry

Description

The purpose of this project is to create a database, which will allow us to contact participants for active studies as well as other research opportunities within our program.

This database registry project is designed to give an opportunity to interested patients with schizophrenia or schizoaffective disorder to have access to the various research studies that the MPC Research Program has available.

Study Length
One time registration
Study Location
Manhattan Psychiatric Center’s 125th Street Clinic, 163 West 125th Street, NY
Inclusion Criteria
  • Male and female patients
  • 18-65 years of age
  • Diagnosis: Schizophrenia or Schizoaffective Disorder 
Exclusion Criteria
  • Non-English speaking patients
  • Pregnancy
Contact

Mohan Parak, M.D., Study Coordinator at 212-961-4016 or Mohan.parak@omh.ny.gov

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Other Opportunities

Rockland Sample

This research program offers an opportunity for people of all ages—from 6 to 85—who live in Rockland County and neighboring areas to make a real difference.

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Title

Rockland Sample

Description

The NKI Rockland Sample Initiative is a landmark research program aiming to map the brain, understand how it develops and changes over the course of life, and explore the connections between our brain and behavior.  Studies like this have the potential to change how we treat diseases from depression to Alzheimer’s.

This research program offers an opportunity for people of all ages—from 6 to 85—who live in Rockland County and neighboring areas to make a real difference. Over 1,400 residents have made the call and joined in the Rockland Sample, but we still need hundreds more. Here you can learn about our studies and the science behind them, and find out about the free programs we offer to schools and community organizations.

Find Out More (http://rocklandsample.org)

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Volunteer Recruitment Pool

The Volunteer Recruitment Pool (VRP) is the primary entry point for individuals (ages 6 and up) who are interested in research participation at the Nathan Kline Institute (NKI).  

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Title

Volunteer Recruitment Pool

Description

The Volunteer Recruitment Pool (VRP) is the primary entry point for individuals (ages 6 and up) who are interested in research participation at the Nathan Kline Institute (NKI).  After scheduling an appointment with a staff member in the Clinical Evaluation Center (CEC), interested individuals visit NKI for about 90 minutes.  During this time, they first learn more about the VRP and have their questions answered.  If they remain interested in participating, some basic information is collected (including contact information and basic medical history).  The individual then has an interview (usually about one hour in length) to review past and present mental health symptoms, if any.  For children (under 18 years old), the parent/guardian is also required and the interview is usually about 2 hours.  Feedback is provided to children and their guardian.  Adult VRP participants receive $20 for their time.  The information collected is then stored in a protected and confidential database within CEC.  The CEC then uses this information to match VRP participants with NKI research scientists who are investigating scientific questions.  If there is a match, NKI staff will contact the VRP participant to present the research opportunity.  All research programs, including the VRP, are voluntary at NKI.  If you are interested, please contact us at: 845-398-2184 or vrp@nki.rfmh.org.

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