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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

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.
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 Antero Sarreal at (845) 398-6532 or asarreal@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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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 Spectrum Disorder (ASD)

The aViation Study

The aViation study will assess an investigational medicine for autism spectrum disorder (ASD). The study will test whether an investigational study drug can improve the social communication and interaction skills of 5-to-17 year olds with ‘high-functioning’ ASD. The investigational study drug blocks a hormone receptor in the brain that is linked to the control of socialization, stress, anxiety, and aggression. 

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Title

A phase II multi-center, randomized, double blind, 24-week, 3-arm, parallel group, placebo-controlled study to investigate the efficacy and safety of RO5285119 in children and adolescents age 5-17 with autism spectrum disorder (ASD)

Description

The aViation study will assess an investigational medicine for autism spectrum disorder (ASD). The study will test whether an investigational study drug can improve the social communication and interaction skills of 5-to-17 year olds with ‘high-functioning’ ASD. The investigational study drug blocks a hormone receptor in the brain that is linked to the control of socialization, stress, anxiety, and aggression. 

Study Length
39 weeks
Inclusion Criteria

Ages 5-17 with high functioning ASD

Contact

Alexis Lieval at 845-398-2184 or vrp@nki.rfmh.org

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Depression

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

This research study is testing whether the combination of the drugs brexpiprazole and intranasal ketamine can safely and effectively treat people with depression who are already taking an antidepressant medication but have not had a satisfactory response. Participants will be randomized (like flipping a coin) to receive 40 mg of ketamine administered intranasally plus either the active study medication (brexpiprazole) or placebo.

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Title

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

Study Length
12 study visits over about five to eight weeks
Inclusion Criteria

Men or women between the ages of 18 and 65 who are currently taking antidepressant medication but have not had a satisfactory result. Participants should be in good general health and willing to use birth control if of child bearing potential.

Contact

Karen Nolan, 845-398-6572, nolan@nki.rfmh.org

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Transcranial Continuous and Pulse Near-Infrared Light in Depression: a Placebo Controlled Study (ELATED-3)

Transcranial Light Therapy (TLT) involves non-invasive and invisible beams of light that increase energy metabolism in the brain, which may help people with depression. This treatment is not the same as electroconvulsive therapy (ECT).

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Title

Transcranial Continuous and Pulse Near-Infrared Light in Depression: a Placebo Controlled Study (ELATED-3)

Description

Transcranial Light Therapy (TLT) involves non-invasive and invisible beams of light that increase energy metabolism in the brain, which may help people with depression. This treatment is not the same as electroconvulsive therapy (ECT). All TLT sessions will take place at the Nathan Kline Institute. Those who qualify will receive the experimental treatment, study-related, medical exams, and laboratory tests at no cost and will be compensated $50 per study visit. See ClinicalTrials.gov for more information.

Study Length
The visits include 1 initial screening visit, 24 TLT sessions (twice a week for 12 weeks), and 1 follow-up visit making for a total of 26 visits to our program.
Inclusion Criteria

Adults (aged 18 to 70 years) who meet criteria for Major Depressive Disorder, in good general health. If taking antidepressant medication(s), must be on stable dose(s) for at least 6 weeks prior to enrollment.

Contact

Karen Nolan: 845-398-6572, nolan@nki.rfmh.org

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Schizophrenia

An Open-Label, Multi-Center Trial to Assess the Safety and Effectiveness of ITI-007 in Patients with Schizophrenia

Primary objectives are to determine whether ITI-007 administered once daily for up to 1 year to patients with schizophrenia improves psychopathology, social functioning, and quality of life as measured by change from baseline and to determine the safety of ITI-007.

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Title

An Open-Label, Multi-Center Trial to Assess the Safety and Effectiveness of ITI-007 in Patients with Schizophrenia

Description

Primary objectives are to determine whether ITI-007 administered once daily for up to 1 year to patients with schizophrenia improves psychopathology, social functioning, and quality of life as measured by change from baseline and to determine the safety of ITI-007.

Study Length
1 year
Inclusion Criteria

Patients will be male or female, aged 18 or older, with a current clinical diagnosis of schizophrenia according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) and who are otherwise in good general health.

Patients meeting all of the following criteria will be considered for admission to the study:

1. Male or female patients of any race, age 18 or older, with a clinical diagnosis of schizophrenia according to DSM-5 criteria;

2. Patients must be stable with respect to their schizophrenia symptoms and able to be treated with an investigational drug on an outpatient basis, in the opinion of the Investigator;

3. Patients must agree to use highly effective methods of birth control starting with signing informed consent through to the end of study follow-up visit or must be of non-childbearing potential;

4. Patients must be able to provide written informed consent, where the patient is fluent and literate in a language spoken by the Investigator and/or subinvestigator;

5. Patients must be willing to comply with all Investigator and staff instructions.

Exclusion Criteria

1. Any female patient who is pregnant or breast-feeding; female patients of childbearing potential must have a negative urine pregnancy test at screening and on Study Day 1 before the first dose of study treatment is administered;

2. Any patient who has experienced intolerance to, allergy, or sensitivity to ITI-007 or to another antipsychotic or other psychotropic drug;

3. Any patient considered to be an imminent danger to themselves or others;

4. Any patient reporting suicidal ideation of type 4 or 5 on the C-SSRS within 30 days before the first dose of study treatment is administered or any suicidal behavior in the last 2 years before the first dose of study treatment is administered, as indicated by any ‘yes’ answers on suicidal behavior section of C-SSRS;

5. Any patient with abnormal laboratory values or clinical findings on screening, that are judged clinically significant, including, but not limited to:

i. QTcF > 450 ms,

ii. ALT, AST, or CPK values > 3X upper limit of normal,

iii. a history of Hepatitis B or C infection or demonstration of Hepatitis B or C antibodies,

iv. demonstration of HIV antibodies,

v. a positive qualitative urine drug test at screening, or evidence of either withdrawal from, or acute intoxication with cocaine, opiates, (meth)amphetamines, barbiturates, or hallucinogens or similar compounds;

6. Any patient with a presence, or history within 6 months before the first dose of study treatment, of significant and/or uncontrolled hematological, renal, hepatic, endocrinological (including poorly controlled diabetes defined as HbA1c > 53 mmol/mol [7.0%] on screening), neurological, or cardiovascular disease or who has a primary diagnosis of a mental illness other than schizophrenia according to DSM-5 criteria;

7. Any patient with a history of neuroleptic malignant syndrome induced by antipsychotic medication;

8. Any patient taking other antipsychotic medication;

9. Any patient taking a strong P450 CYP 3A4 inhibitor or inducer (Appendix A);

10. Any patient that has participated with an investigational product other than ITI-007 within the past 60-days;

11. Any patient that is currently in an unstable living environment, as judged by the Investigator;

12. Any patient judged by the Investigator to be inappropriate for the study.

Contact

Abraham Goldring, M.A., Research Coordinator, at 212-961-8992 or Abraham.goldring@omh.ny.gov

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Brief Adherence Rating Scale (BARS)

The purpose of this study is to compare response rates for subjects with schizophrenia identified as non-adherent, using the Brief Adherence Rating Scale (BARS), over three months of treatment with aripiprazole once monthly versus standard of care (SOC) oral antipsychotics.

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Title

A Two-Stage, Phase 4, Randomized, Two-Arm, Rater-Blinded, Multi-Site, Parallel-Group Study Designed to Compare Response Rates for Subjects with Schizophrenia Identified as Non-Adherent, Using the Brief Adherence Rating Scale (BARS), Over Three Months of Treatment with Aripiprazole Once Monthly Versus Standard of Care (SOC) Oral Antipsychotics

Description

The purpose of this study is to compare response rates for subjects with schizophrenia identified as non-adherent, using the Brief Adherence Rating Scale (BARS), over three months of treatment with aripiprazole once monthly versus standard of care (SOC) oral antipsychotics.

Study Length
3 months
Inclusion Criteria

Male or female, 18-60 years old, inclusive. Current diagnosis of schizophrenia as defined by DSM-5 criteria and a history of illness for at least 6 months prior to screening. Has been prescribed a single oral antipsychotic medication for at least 3 months prior to screening. Has been prescribed a minimal therapeutic dose of antipsychotic for at least 6 weeks prior to screening defined as a total daily dose.

Exclusion Criteria

Diagnoses other than schizophrenia as diagnosed by DSM-5 criteria. Psychiatric hospitalization within 30 days prior to screening. Treatment with depot antipsychotic within the past 6 months prior to screening. Patient is considered resistant or refractory to antipsychotic treatment by history, or responds only to clozapine. Currently taking a cytochrome P450 (CYP) 3A4 inducer. History of seizures.

Contact

Abraham Goldring – (212) 961-8992 / AGoldring@nki.rfmh.org, or Benedicto Parker – (212) 866-2690 / bparker@nki.rfmh.org

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The Virtual Reality Functional Capacity Assessment Tool

The purpose of this study is to test the ability of the novel VRFCAT program to help assess inpatients’ readiness for discharge once a patient is considered ready for discharge by their clinicians.

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Title

The Virtual Reality Functional Capacity Assessment Tool (VRFCAT) As an Assessment for Readiness for Discharge

Description

The purpose of this study is to test the ability of the novel VRFCAT program to help assess inpatients’ readiness for discharge once a patient is considered ready for discharge by their clinicians.

Study Length
4 weeks
Inclusion Criteria

Male or female adults, age ≥ 18. Diagnosis of schizophrenia or schizoaffective disorder (all subtypes) as defined by the DSM-V. Considered ready for discharge from the hospital by their clinicians, as documented by being placed on the discharge list by their psychiatrist. On a stable antipsychotic regimen 4 weeks prior to screening and for the duration of the follow up period.

Exclusion Criteria

Actively suicidal and or showing violent behavior; Unstable medical condition. Individuals with a clinically defined neurological disorder. History of intellectual impairment pre-dating onset of symptoms of psychosis (e.g. mental retardation).

Contact

Abraham Goldring (212) 961-8992 / AGoldring@nki.rfmh.org or Mohan Parak (646) 672-6179 / parak@nki.rfmh.org

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Weight Gain of ALKS 3831 compared to Olanzapine

The purpose of this study is to evaluate weight gain of ALKS 3831 (a fixed-dose combination of olanzapine and samidorphan) compared to olanzapine in adults with schizophrenia.

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Title

A Phase 3 Study to Evaluate Weight Gain of ALKS 3831 compared to Olanzapine in Adults with Schizophrenia.

Description

The purpose of this study is to evaluate weight gain of ALKS 3831 (a fixed-dose combination of olanzapine and samidorphan) compared to olanzapine in adults with schizophrenia.

Study Length
32 weeks
Inclusion Criteria

Inclusion Criteria: Males and females, 18-55 years of age, inclusive. Patients who meet DSM-5 criteria for primary schizophrenia using the M.I.N.I. Body mass index of (BMI) of 18 – 30 kg/m2. Exclusion Criteria: Subject has used clozapine, olanzapine, chlorpromazine, thioridazine and long acting injectables within 6 months prior to visit 1. HbA1c > 6 and fasting plasma glucose > 126 mg/dl at visit 1. History of diabetes. Currently taking any weight loss agents or hypoglycemic agents. Unstable medical condition or neurologic condition (including history of seizure disorder, brain tumor or head trauma with LOC within 12 months).

Contact

Mohan Parak – (646) 672-6179 / parak@nki.rfmh.org, Benedicto Parker – (212) 866-2690 / bparker@nki.rfmh.org, or Abraham Goldring – (212) 961-8992 / AGoldring@nki.rfmh.org

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Schizophrenia and Aggressive behaviors

Can Cognitive Training Decrease Reactive Aggression? The Role of Improved Emotion Regulation, Emotion Awareness, and Impulse Control

The purpose of this study is to find out if participating in computer based cognitive training activities can improve your ability to manage your emotions. Severe mental illnesses can contribute to problems managing emotions during stressful situations. These difficulties with managing emotions result from difficulties with cognition. Cognition refers to your thinking skills—your ability to remember, focus, think quickly, reason, solve problems, and recognize other people’s emotions.

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Title

Can Cognitive Training Decrease Reactive Aggression? The Role of Improved Emotion Regulation, Emotion Awareness, and Impulse Control

Study Length
You will be asked to participate in the cognitive training program three days a week for 12 weeks. Each session will last about 60 minutes.
Inclusion Criteria
  • Age 18 – 60 years.
  • Auditory and visual acuity adequate to complete cognitive tests.
  • Stable psychiatric medication status.
  • Some episodes of aggression  in the past year.
  • Sufficient reading score.
Exclusion Criteria
  • Inability to read or speak English.
  • Documented significant disease of the central nervous system.
  • History of intellectual impairment pre-dating onset of symptoms of psychosis.
  • Unstable cardiovascular, renal, hepatic, gastrointestinal, pulmonary or hematological conditions.
Contact

Isidora Ljuri, MA, at (646) 672-6173 or Isidora.ljuri@omh.ny.gov.

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Schizophrenia and cognitive deficits

Basmisanil as adjunctive treatment in patients with cognitive impairment associated with schizophrenia treated with antipsychotics

The purpose of this study is to find out what effects basmisanil has on you and your cognitive functions, such as memory, attention, language, and ability to plan and solve problems, when added to your current medication.

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Title

A multicenter, randomized, double-blind, parallel group, placebo-controlled study to evaluate the efficacy, safety and tolerability of basmisanil as adjunctive treatment in patients with cognitive impairment associated with schizophrenia treated with antipsychotics

Study Length
The study consists of up to 14 visits over approximately 8 months.
Inclusion Criteria
  • Male or female, between 18 and 50 years.
  • Evidence of stability of symptoms for 3 months at screening.
  • On a stable regimen of antipsychotic therapy for at least 3 months at screening.
  • Has identified a reliable informant.
Exclusion Criteria
  • Clinically significant metabolic, hepatic, hematological, or cardiovascular disorders.
  • Any history of diagnosed seizure disorder.
  • Positive result for hepatitis B (HBV), hepatitis C (HCV), or human immunodeficiency virus (HIV)-1 and -2.
Contact

Amod Thanju, MD, at (212) 961-8992 or Amod.thanju@omh.ny.gov.

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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
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 212-961-8992 or Mohan.parak@omh.ny.gov

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The Psychometric Properties of the Self-Evaluation of Negative Symptoms scale (SNS) in a population of treatment resistant schizophrenia (TRS)

The aim of the present study is to first evaluate the psychometric properties of the novel tool of self-evaluation of Negative Symptoms (SNS) and its association with observer ratings of negative symptoms in a sample of patients with treatment resistant ICD 10 schizophrenia or schizoaffective disorder. The second aim is to examine the correlation of the SNS ratings with the level of insight in this patient sample.

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Title

The Psychometric Properties of the Self-Evaluation of Negative Symptoms scale (SNS) in a population of treatment resistant schizophrenia (TRS)

Description

The aim of the present study is to first evaluate the psychometric properties of the novel tool of self-evaluation of Negative Symptoms (SNS) and its association with observer ratings of negative symptoms in a sample of patients with treatment resistant ICD 10 schizophrenia or schizoaffective disorder. The second aim is to examine the correlation of the SNS ratings with the level of insight in this patient sample.

Study Length
2 days
Inclusion Criteria
  • Inpatient or outpatient status
  • Age ≥ 18-65; Male/Female gender
  • ICD-10 diagnosis of schizophrenia or schizoaffective disorder (all subtypes)
  • Capacity and willingness to give written informed consent
  • Adequate visual function
  • English speaking
  • Presence of negative symptoms
  • Treatment refractoriness as demonstrated by residual positive and negative symptoms after two adequate antipsychotic trials at adequate length of time
Exclusion Criteria
  • Actively suicidal and or showing violent behavior
  • Individuals with a clinically defined neurological disorder
  • History of intellectual impairment pre-dating onset of symptoms of psychosis (e.g. Intellectual Disability)
Contact

Amanda Hefner, Research Coordinator at 212-961-8992 or Amanda.hefner@omh.ny.gov

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Schizophrenia with poor response to current medication

Interventional, open-label, flexible dose, long-term safety study of Lu AF35700 in adult patients with schizophrenia

We are testing the long-term safety and tolerability of daily and weekly doses of an investigative drug, Lu AF35700, in patients with schizophrenia who are having problems with their current antipsychotic treatment and are considering switching treatment.

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Title

Interventional, open-label, flexible dose, long-term safety study of Lu AF35700 in adult patients with schizophrenia

Description

We are testing the long-term safety and tolerability of daily and weekly doses of an investigative drug, Lu AF35700, in patients with schizophrenia who are having problems with their current antipsychotic treatment and are considering switching treatment.

Study Length
52 weeks with regular visits with the outpatient team.
Inclusion Criteria
  • Treatment with antipsychotic medication(s) during 6 weeks prior to screening.
  • The patient is a man or woman, aged ≥18 years.
  • A caregiver or an identified reliable and responsible person to provide support to the patient.
  • The patient is in need of a change in the current antipsychotic treatment and, according to the investigator’s clinical judgment, the patient can potentially benefit from a switch to another treatment.
Exclusion Criteria
  • Has primary psychiatric disorder other than schizophrenia.
  • The patient is experiencing an acute exacerbation of his/her psychotic symptoms according to the investigator’s judgment.
  • The patient has a substance use disorder which may affect study participation.
  • The patient is at significant risk of harming himself/herself.
  • The patient has been treated with, AND is resistant to, clozapine.
Contact

Tania Sultana at (212) 961-8992, Tania.Sultana@omh.ny.gov, or Benedicto Parker at (212) 961-8992, Benedicto.parker@omh.ny.gov.

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Schizophrenia with poor response to current medications

Interventional, randomized, double-blind, active-controlled, fixed-dose study of Lu AF35700 in patients with Treatment-resistant Schizophrenia

We are testing whether this new medication for schizophrenia, which has a different profile than the presently available medicines, could be an effective treatment for patients with schizophrenia who do not respond adequately to drugs such as olanzapine or risperidone.

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Title

Interventional, randomized, double-blind, active-controlled, fixed-dose study of Lu AF35700 in patients with Treatment-resistant Schizophrenia

Study Length
25 weeks with regular visits with the outpatient research team.
Inclusion Criteria
  • Treatment  with the same dose(s) and antipsychotic medication(s) during 6 weeks prior to Screening.
  • Failure to show an adequate response in the level of psychotic symptoms despite at least one treatment trial with an adequate dose of an antipsychotic agent for at least 6 weeks, during 2 years prior to Screening.
  • The patient is a man or woman, aged ≥18 years.
  • A caregiver or an identified reliable and responsible person to provide support to the patient.
Exclusion Criteria
  • A current primary psychiatric disorder other than schizophrenia as assessed by MINI-Schz (Mini International Neuropsychiatric Interview for Schizophrenia and Psychotic Disorders).
  • The patient is experiencing an acute exacerbation of his/her psychotic symptoms according to the investigator’s judgement.
  • The patient has experienced a satisfactory symptom relief as a result of antipsychotic therapy during 2 years prior to Screening.
  • The patient is at significant risk of harming himself/herself.
  • The patient has been treated with, AND is resistant to, clozapine.
Contact

Benedicto Parker at (212) 961-8992, Benedicto.parker@omh.ny.gov. Amod Thanju,MD at (212) 961-8992, Amod.thanju@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 800 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 Outpatient Research Department (OPRD), 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 OPRD.  The OPRD 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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