Current Trials and Research Opportunities Include:
Research Studies & Clinical Trials
Alzheimer's Disease
ADNI 3 (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 3 (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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The AZTherapies Study
This study is sponsored by AZTherapies, Inc. The clinical research study AZT-001 is being conducted to assess whether to test the effects of two drugs on memory - cromolyn sodium and ibuprofen - in people with clinical signs and symptoms of early Alzheimer’s disease (AD). Cromolyn sodium is taken using a mouth inhaler device (similar to those used in the treatment of asthma) once a day, and ibuprofen is taken orally (by mouth) as a tablet once a day. Both of these drugs are approved by the FDA for use in the treatment of asthma and inflammation, respectively.
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Title
The AZTherapies Study
Description
This study is sponsored by AZTherapies, Inc. The clinical research study AZT-001 is being conducted to assess whether to test the effects of two drugs on memory - cromolyn sodium and ibuprofen - in people with clinical signs and symptoms of early Alzheimer’s disease (AD). Cromolyn sodium is taken using a mouth inhaler device (similar to those used in the treatment of asthma) once a day, and ibuprofen is taken orally (by mouth) as a tablet once a day. Both of these drugs are approved by the FDA for use in the treatment of asthma and inflammation, respectively.
These two drugs have never been tested as a combination treatment for AD and the use of these drugs, either alone or in combination, is not approved by the FDA for the treatment of AD. This research will investigate whether one drug or the combination of the two has any effect on memory problems associated with AD. Cromolyn has been found to block the production of toxic forms of the Abeta protein which have been implicated in the development and progression of AD. Ibuprofen dampens the neuroinflammation which is also found in the brains of AD patients. Thus, together these drugs may contribute both to the prevention of AD as well as slowing its progression. This study will also examine any side-effects that people may experience.
Study Length
The double-blind phase of the study will last 72 weeks or approximately 1 ½ years.
Inclusion Criteria
The study is open to both male and female subjects aged 55-79 years diagnosed with early stage AD.
Contact
Raymundo Hernando, MD at 845-398-5578 or hernando@nki.rfmh.org
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The EARLY Study (Janssen)
The EARLY Trial is being conducted to evaluate the safety and effectiveness of an investigational medication called JNJ-54861911, to determine whether it can prevent memory loss associated with Alzheimer’s disease.
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Title
The EARLY Study (Janssen)
Description
The EARLY Trial is being conducted to evaluate the safety and effectiveness of an investigational medication called JNJ-54861911, to determine whether it can prevent memory loss associated with Alzheimer’s disease. JNJ-54861911 has been designed to reduce the activity of a substance in the brain involved in producing beta-amyloid. Beta-amyloid is a protein that is normally produced and quickly cleared from the brain. Accumulation of beta-amyloid in the brain, resulting in amyloid plaques, is associated with the development of Alzheimer’s disease dementia. Evidence of amyloid plaque buildup in people with normal memory function has been linked to an increased risk for developing Alzheimer’s disease dementia in their future. Dementia due to Alzheimer’s disease is characterized by a progressive decline in memory and other thinking abilities (eg, difficulties with problem-solving or formulating speech), severe enough to limit a person’s independent daily function. The EARLY Trial will help us to better understand the relationship between amyloid, memory loss, and the development of Alzheimer’s disease dementia. Participants will be in the EARLY Trial for about 5 years.
Study Length
Participants will be in the EARLY Trial for about 5 years.
Contact
For more information, please contact Raymundo Hernando at (845) 398-5578 or hernando@nki.rfmh.org.
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The Generation Study (Novartis)
The clinical research study CAPI015A2201J is being conducted to assess whether CAD106 is safe and has beneficial effects in people who may be at elevated risk for the onset of clinical symptoms of Alzheimer’s disease due to their age and genetic status (carrying two copies of a version of the APOE gene called APOE-ε4 allele).
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Title
The Generation Study (Novartis)
Description
This study is sponsored by the NIH, and the pharmaceutical company Novartis in partnership with the Banner Alzheimer’s Institute. The clinical research study CAPI015A2201J is being conducted to assess whether CAD106 is safe and has beneficial effects in people who may be at elevated risk for the onset of clinical symptoms of Alzheimer’s disease due to their age and genetic status (carrying two copies of a version of the APOE gene called APOE-ε4 allele). Additionally, this study will examine the effects of each of the two therapies CAD 106 and CNP520 given separately and targeting brain amyloid on cognition, global clinical status, and underlying pathology in participants at risk for the onset of clinical symptoms of AD.
Study Length
The double-blind phase of the study will last a possible minimum of 60 months.
Study Location
Nathan Kline Institute -- Orangeburg, NY
Inclusion Criteria
Potential subjects must be cognitively intact individuals with 2 copies of the APOE-ε4 allele, age 60 to 75 years, inclusive, selected as they represent a population at particularly high risk of progression to MCI due to AD and/or dementia due to AD. The subject must score greater than a 24 on the Folstein (MMSE).
Contact
For more information, please contact Katie Brundage at (845) 398-6533 or katherine.brundage@nki.rfmh.org.
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Alzheimer's Disease and Agitation
The Triad Study (Avanir)
This clinical trial sponsored by AVANIR pharmaceuticals has a double-blind and an open label-phase. This study will investigate the effectiveness of an experimental drug for the treatment of agitation in individuals with Alzheimer’s disease. Agitation is quite common in this patient population (includes the following types of behaviors: screaming, cussing, destroying objects, grabbing, fighting, and pacing) and can be extremely distressing to the individual, the family, and caregivers, and generally does not respond to conventional medications.
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Title
The Triad Study (Avanir)
Description
This clinical trial sponsored by AVANIR pharmaceuticals has a double-blind and an open label-phase. This study will investigate the effectiveness of an experimental drug for the treatment of agitation in individuals with Alzheimer’s disease. Agitation is quite common in this patient population (includes the following types of behaviors: screaming, cussing, destroying objects, grabbing, fighting, and pacing) and can be extremely distressing to the individual, the family, and caregivers, and generally does not respond to conventional medications.
The experimental drug that will be used in this study, dextromethorphan, is the active ingredient used in over-the-counter cough syrup medicines and of a medication which has been approved by the FDA for the treatment of uncontrollable crying/laughing associated with psuedobulbar palsy.
Study Length
The double-blind phase of the study will last 3 months and the open-label extension phase of the study will last up to 12 months.
Inclusion Criteria
Potential subjects must be between 50-90 years old with clinically significant, moderate/severe agitation secondary to dementia of the Alzheimer’s type. The subjects must score between 6 – 26 on the Folstein (MMSE).
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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Autism
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.
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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
Approximately 5.5 months
Study Location
Nathan Kline Institute, Orangeburg, NY
Inclusion Criteria
Males and Females, ages 15-45 with ASD
Contact
Clinical Evaluation Center at 845-398-2184 or vrp@nki.rfmh.org
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A Three-arm, Parallel Group, Randomized, Double-blind, Placebo-controlled Study of the Efficacy, Safety, and Tolerability of AB-2004 in a 13- to 17-year-old Autism Spectrum Disorder Population
The primary objective of this study is to evaluate the effectiveness and safety of an investigational medication compared with placebo in improving irritability symptoms in individuals with ASD.
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Title
A Three-arm, Parallel Group, Randomized, Double-blind, Placebo-controlled Study of the Efficacy, Safety, and Tolerability of AB-2004 in a 13- to 17-year-old Autism Spectrum Disorder Population
Description
The primary objective of this study is to evaluate the effectiveness and safety of an investigational medication compared with placebo in improving irritability symptoms in individuals with ASD.
Study Length
Approximately 4 months
Study Location
Nathan Kline Institute, Orangeburg, NY
Inclusion Criteria
Males and Females, ages 13-17 with ASD and presence of irritability and GI symptoms
Contact
Clinical Evaluation Center at 845-398-2184 or vrp@nki.rfmh.org
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Depression
Biobehavioral Predictors of Illness Progression in Adolescent Depression
The primary objective of this joint study with Albert Einstein and Mt. Sinai Medical Centers is to understand mechanisms driving recovery, persistence, or progression of depressive symptoms in teens.
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Title
Biobehavioral Predictors of Illness Progression in Adolescent Depression
Description
The primary objective of this joint study with Albert Einstein and Mt. Sinai Medical Centers is to understand mechanisms driving recovery, persistence, or progression of depressive symptoms in teens.
Study Length
2 years
Study Location
Nathan Kline Institute, Orangeburg, NY
Inclusion Criteria
Males and Females, ages 13-17 with depression
Contact
Clinical Evaluation Center at 845-398-2184 or vrp@nki.rfmh.org
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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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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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Major Depressive Disorder/Depression
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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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.
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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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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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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.
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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
2 study visits, with each visit taking approximately 3-4 hours, over the course of 1-3 weeks. The total number of hours will be approximately 6-8.
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 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.
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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 Shuaib Ahmad, research coordinator, at 646-766-5869 or Shuaib.Ahmad@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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Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Effects of RO6889450 in Patients with Schizophrenia or Schizoaffective Disorder And Negative Symptoms
RO6889450 is a novel compound and a potent partial agonist of Trace Amine-Associated Receptor 1 (TAAR1) for the treatment of negative symptoms in schizophrenia. This site is conducting Part B (add-on therapy) wherein participants will be randomized 1:1:1 to 45 mg QD of RO6889450, 150 mg QD of RO6889450, or placebo for 12 weeks. Stratification will be based on BNSS avolition/apathy subscore (sum of items “behavior” and “internal experience”; ≤6 vs. >6), age (18-35 years vs. 36-55 years), sex, and antipsychotic treatment (1:1 stratification ratio between dopamine 2 receptor [D2]/serotonin 2A [5HT2A] receptor antagonists and D2 partial agonist).
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Title
Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Effects of RO6889450 in Patients with Schizophrenia or Schizoaffective Disorder And Negative Symptoms; Protocol BP40283
Description
RO6889450 is a novel compound and a potent partial agonist of Trace Amine-Associated Receptor 1 (TAAR1) for the treatment of negative symptoms in schizophrenia. This site is conducting Part B (add-on therapy) wherein participants will be randomized 1:1:1 to 45 mg QD of RO6889450, 150 mg QD of RO6889450, or placebo for 12 weeks. Stratification will be based on BNSS avolition/apathy subscore (sum of items “behavior” and “internal experience”; ≤6 vs. >6), age (18-35 years vs. 36-55 years), sex, and antipsychotic treatment (1:1 stratification ratio between dopamine 2 receptor [D2]/serotonin 2A [5HT2A] receptor antagonists and D2 partial agonist).
Study Length
Twenty weeks. Study participants will need to come at least 11 times to the study site during the study period.
Study Location
Manhattan Psychiatric Center’s 125th Street Clinic -- 163 West 125th Street, 11th and 12th Floors, NY, NY 10027
Inclusion Criteria
- Stable outpatients with DSM-5 diagnosis of schizophrenia or schizoaffective disorder
- 18 to 55 years of age
- Stable treatment with a D2/5HT2A antagonists or a D2 partial agonist for a minimum of six months and receiving no more than two antipsychotics
- Has an informant who is considered reliable to provide support and to help ensure compliance with study visits and protocol procedures
- Body mass index (BMI) between 18 and 40 kg/m2 inclusive
Please note that this is not the full list of study eligibility criteria.
Exclusion Criteria
- Moderate to severe substance use disorder within six months (excluding nicotine or caffeine) as defined by DSM-5
- Other current DSM-5 diagnosis (e.g., bipolar disorder, major depressive disorder)
- Significant medical and/or major neurologic disorder impairing cognition
- Positive urine drug screen for amphetamines, methamphetamines, opiates, buprenorphine, methadone, cannabinoids (including cannabidiol), cocaine and barbiturates
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
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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