Current Trials and Research Opportunities Include:
Research Studies & Clinical Trials
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.
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
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.
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).
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.
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.
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
Study Location
Inclusion Criteria
- Have memory problems
- Willing to travel to NKI
Contact
Zamfira Parincu, 845-398-6571 or zamfira.parincu@nki.rfmh.org
Autism Spectrum Disorder
A Phase II Multicenter, Randomized, Double-Blind, 12-Week Treatment, 3-Arm, Parallel-Group, Placebo-Controlled Study to Investigate the Efficacy, Safety and Tolerability of RO7017773 in Participants Aged 15 to 45 Years with Autism Spectrum Disorder (ASD)
The primary objective of this study is to evaluate the effectiveness and safety of RO7017773, a new medication, compared with placebo in the improvement of symptoms of ASD.
Title
A Phase II Multicenter, Randomized, Double-Blind, 12-Week Treatment, 3-Arm, Parallel-Group, Placebo-Controlled Study to Investigate the Efficacy, Safety and Tolerability of RO7017773 in Participants Aged 15 to 45 Years with Autism Spectrum Disorder (ASD)
Description
The primary objective of this study is to evaluate the effectiveness and safety of RO7017773, a new medication, compared with placebo in the improvement of symptoms of ASD.
Study Length
Study Location
Inclusion Criteria
Males and Females, ages 15-45 with ASD
Contact
Lucia Tu at Lucia.Tu@NKI.rfmh.org or (845) 398-6620.
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.
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
Study Location
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
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.
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
Study Location
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.
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).
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
Study Location
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
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).
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
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
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.
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
Inclusion Criteria
18-65 years old
Contact
Zamfira Parincu at 845-398-6571 or Zamfira.Parincu@nki.rfmh.org
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.
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
Study Location
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.
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.
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
Study Location
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.
Neurobiology of sensory phenomena in obsessive-compulsive disorder
This project investigates brain function associated with sensory symptoms in patients with obsessive-compulsive disorder (OCD) and their siblings using magnetic resonance imaging (MRI). Participants will have a comprehensive symptom assessment during one visit, and an MRI scan at the second visit.
Title
Neurobiology of sensory phenomena in obsessive-compulsive disorder
Description
This project investigates brain function associated with sensory symptoms in patients with obsessive-compulsive disorder (OCD) and their siblings using magnetic resonance imaging (MRI). Participants will have a comprehensive symptom assessment during one visit, and an MRI scan at the second visit.
Study Length
Study Location
Inclusion Criteria
Men and women between the ages of 18 and 60 who have obsessive-compulsive disorder or have a biological sibling with obsessive compulsive disorder. Participants should be in good general health.
Contact
Nicolette Recchia at 845-398-5590 or pnclab@nki.rfmh.org.
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).
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
Study Location
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.
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.
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
Study Location
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.
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).
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
Study Location
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.
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.
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
Study Location
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,
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.
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
Study Location
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
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.
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
Study Location
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
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.
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)
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).
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.