The Columbia Schizophrenia Research Center
The Columbia Schizophrenia Research Center (CSRC) is located at the New York State Psychiatric Institute (NYSPI) on the Columbia-Presbyterian Medical Campus, and is part of the Columbia University Department of Psychiatry.
Our research center is a fully functioning clinic which includes a staff of doctors and trained research scientists. Our clinical staff provides outpatient services, free of charge, to individuals participating in research studies conducted by NYSPI and Columbia faculty investigators. Treatment services include: a full psychiatric evaluation; individual medication management visits with a clinical psychiatrist; and individual therapies. The ability to follow patients over time helps to develop a comprehensive knowledge base about schizophrenia.
We specialize in schizophrenia (and schizoaffective disorder) research and conduct several research studies at any given time, all of which are designed to answer questions about the nature and causes of schizophrenia/schizoaffective disorder and optimal treatment approaches. Occasionally our studies examine psychiatric disorders other than schizophrenia.
General Criteria for Admission
Individuals willing to participate in research will be considered for admission to the outpatient services we provide. The following general criteria are also required:
- A diagnosis of schizophrenia or schizoaffective disorder
- 18-65 years of age
- No significant medical problems
- No recent history of significant violence or self-injurious behavior
- No current alcohol or substance use disorder
- Ability to give informed consent for the research procedures
About Our Research
The Columbia Schizophrenia Research Center (CSRC) supports a number of research studies designed to answer questions about the nature and causes of schizophrenia and optimal treatment approaches. At any given time, we are typically conducting and recruiting for four or more different studies, for which the specifics of eligibility/ineligibility criteria may vary. However in most cases, a person who meets the criteria in the bulleted list above, “General Criteria for Admission”, would likely be eligible for at least one or more of the studies that we are currently conducting. Research studies are not designed for the individual’s direct benefit. However, research findings that may have clinical significance for treatment are reported to the individual’s clinician. We work closely with our research participants’ clinicians (their Psychiatrist or Doctor, if they have one) and would not enroll anyone in a study if their clinician feels this is a poor idea. If a patient is not currently receiving treatment from a Doctor, we have the ability to take on their clinical care (treatment services include: a full psychiatric evaluation; individual medication management visits with a clinical psychiatrist; and individual therapies)— all free of charge. Of course, medications administered as part of research procedures are free of cost. Once the research study is completed, we can make excellent referrals for patient care or continue to see the patient as needed. If we continue to see a patient clinically after the conclusion of a research study, they would only be responsible for the cost of their medication and not the study center visit itself.
What are some of the research studies conducted through the Columbia Schizophrenia Research Center (CSRC)?
- Clinical drug trials of new medications for cognitive (problem solving and memory) and negative symptoms (motivation and socialization) in schizophrenia
- Studies of novel, state of the art treatments
- Studies of brain anatomy and chemistry using EEG, MRI, fMRI, MRS, and PET
- Electrophysiological evaluation of information processing and memory (e.g. the brain’s reaction to sensory stimulation and memory tasks)
In general, what will research participants be asked to do?
- Complete a physical exam (includes vital signs, blood draw, urine screen, & drug test)
- Take an experimental pharmaceutical drug or placebo
- Wear an EEG cap and undergo an EEG scan
- Undergo an MRI, fMRI, MRS, or PET
- Meet with a psychiatrist, psychologist or staff member and answer questions (using standardized assessment tools [SCID-5 & PANSS]) about their schizophrenia and their mood lately
- NOTE: Most, but not all of our studies involve taking an experimental medication. We do sometimes have studies available that do not require a participant to take any experimental medication.
CONTACT US if you are interested in participating in and/or learning more about our research studies:
Interested individuals should call Melissa (at 646-774-8496) or Amir (at 646-774-8431). Initial phone discussions will focus on gathering basic information and answering questions. Individuals meeting criteria will be invited for an on-site screening interview, to learn more about specific research studies and clinical components of the Columbia Schizophrenia Research Center (CSRC).
Marlene Carlson, M.P.H.
Clinical Coordinator, Columbia Schizophrenia Research Center
New York State Psychiatric Institute
1051 Riverside Drive, Suite 1800
New York, NY 10032
Current Clinical Trials:
Placebo-Controlled Medication Studies:
D1 Study (PF-06412562)-
- Study Title: A Translational and Neurocomputational Evaluation of a D1R Partial Agonist for Schizophrenia
- Brief Description: This is a 6 week long randomized clinical trial (7 study center visits total) which will evaluate four oral doses of a novel experimental medication known as PF-06412562 (a dopamine-1 receptor partial agonist) in outpatient subjects aged 18-45 who are within 5 years of onset of schizophrenia, schizoaffective, or schizophreniform disorder. All subjects who complete the full study will receive a single dose of 4 active doses (1mg, 4mg, 15mg, or 25mg) and placebo once across the 5 study visits in a randomized order. During 5 treatment visits, response to medication or placebo is measured by a spatial working memory task performed by the participant during an fMRI scan. The participants will continue on their current antipsychotic treatment.
Corcept Study I (GRATITUDE I, CORT118335)-
- Study Title: A Phase 2, Randomized, Double-Blind, Placebo-controlled Study Evaluating the Safety, Efficacy, and Pharmacokinetics of MiricoriIant (CORT118335) in Obese Adult Patients with Schizophrenia and Recent Weight Gain While Taking Antipsychotic Medications (GRATITUDE)
- Brief Description: This study will compare miricorilant and placebo, to assess the safety of concurrent administration of miricorilant with an atypical antipsychotic and the efficacy of taking miricorilant in reversing antipsychotic-induced weight gain (AIWG). Outpatients aged 18-65 with a BMI >30 kg/m2 who have started any FDA-approved oral or injectable antipsychotic medication (except clozapine) for the treatment of schizophrenia or bipolar disorder in the last 18 months prior to screening and have since shown an increase in body weight by >5% within 6 months of starting the antipsychotic medication will be randomized 1:1 to receive 600 mg miricorilant or placebo for 12 weeks.
Corcept Study II (GRATITUDE II, CORT118335)-
- Study Title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Miricorilant in Obese Adult Patients with Schizophrenia Taking Antipsychotic Medications (GRATITUDE II)
- Brief Description: This study will assess the efficacy of two dose levels (600 mg and 900 mg) of miricorilant versus placebo in reversing antipsychotic-induced weight gain (AIWG). Participants in this study with a body mass index (BMI) > 30 kg/m2 with schizophrenia currently taking olanzapine, risperidone, paliperidone or quetiapine will be randomized in a 1:1:1 ratio to 600 mg miricorilant, 900 mg miricorilant or placebo for 26 weeks. There are a total of 11 visits in the study.
Roche Study (RO6889450)-
- Study Title: A Phase II, Multi-Center, Randomized, Double Blind, Parallel Group, Placebo-Controlled Trial of the Efficacy and the Safety of RO6889450 (Ralmitaront) vs. Placebo in Patients with an Acute Exacerbation of Schizophrenia or Schizoaffective Disorder
- Brief Description: This is a 4-week, Phase II, multi-center, randomized, double-blind, parallel group, placebo-controlled inpatient study sponsored by Roche. This clinical trial will measure the efficacy and the safety of RO6889450 vs. risperidone vs. placebo in patients aged 18-45 who are within 10 years of illness onset and with an acute exacerbation of schizophrenia or schizoaffective disorder. Patients will not be on concurrent antipsychotics for this research study. Across all sites approximately 280 participants will be randomized in equal proportions (approximately 70 per group) to one of the following 4 treatments: 150 mg RO6889450, 45 mg RO6889450, placebo or risperidone 4 mg once daily for 4 weeks of the double-blind treatment period. Participants will stay for 6 weeks on an inpatient unit, located at New York State Psychiatric Institute while receiving the study medication RO6889450, placebo, or risperidone 4mg once daily for 4 weeks of the double-blind treatment period.
Assessment Study (does not involve experimental medication):
- Study Title: Neural Mechanisms of Reading Dysfunction in Schizophrenia
- Brief Description: This study focuses on reading deficits in first-episode schizophrenia. It is funded by a grant from the National Institute of Mental Health (NIMH). This study addresses how reading deficits affect patients during the earliest phases of the illness (“first episode”) and the immediately preceding period (“clinical high risk”)—especially the relationship between reading disability and social/occupational function (e.g. the ability to succeed at school, hold a job, communicate with others). In total, study procedures (initial screening, auditory measures, visual/oculomotor measures, cognition/outcome measures, social cognition measures, EEG, and fMRI) occur over the span of a total of 6-7 hours and can typically be completed across 2-4 sessions. No experimental medication is required for this study; participants will continue on their current prescribed antipsychotic medications during the study.
Frequently Asked Questions (FAQ):
Will research participants be compensated for volunteering?
Yes— we will compensate volunteers for their time and effort while participating in research. Typically participants would recieve $50-$150 per study center visit.
Are there risks and/or side-effects associated with the research conducted at Columbia Schizophrenia Research Center?
All research poses some risks and some side-effects. Clinical care is our primary concern. Our doctors and the research staff will go over all of the risks and side-effects with research participants. If a participant’s schizophrenia starts to get worse, they may be removed from the study. Research findings that may have clinical significance for treatment are reported to the individual and their clinician.
Do participants need to visit the study center in-person in order to participate in research?
Yes— all of our clinical trials require participants to complete study visits in-person at our clinic, which is located in the New York State Psychiatric Institute building, in Washington Heights (Manhattan, NY). Although some of the procedures involved in research participation can be completed virutally/remotely for some studies, for the most part, most visits will require the participant to be present in-person.
What else does Columbia Schizophrenia Research Center offer?
Treatment services include: a full psychiatric evaluation; individual medication management visits with a clinic psychiatrist; and individual therapy.
How long do the studies last?
Our studies last anywhere from a few weeks to a year, depending on the study.
Can patients continue taking their current medication while participating in research?
Yes— most but not all of our studies involve patients continuing to take antipsychotic medication while participating in the research study. Any exceptions are included in the brief study summaries above.
In general, what will research participants be asked to do?
A bulleted list of some general prodecedures typically involved in research participation is included at the top of this page.
Who should I contact to learn more about research at Columbia Schizophrenia Research Center?
Our recruitment staff is happy to answer any questions about our current studies. To learn more or to find out if you are eligible to participate in current studies, please call 646-774-8496 or 646-774-8431.