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 includes a team of doctors, trained research scientists, and other staff. 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 Eligibility
The following general criteria are also typically required, although some individual studies may have broader criteria:
- 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 multiple different studies, for which the specifics of eligibility/ineligibility criteria may vary. In most cases, a person who meets the criteria in the bulleted list above, “General Criteria for Eligibility”, 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 also maintain communication with our research participants’ clinicians (their psychiatrist or treatment team, if they have one) during the research process. Medications administered as part of research procedures are free of cost. However, we cannot cover the cost of medications that patients are taking outside of our research. Once the research study is completed, and if needed for the participant, we will make an outside referral for patient care.
What are some of the research studies conducted through the Columbia Schizophrenia Research Center (CSRC)?
- Clinical drug trials of new medications, devices, or behavioral treatments for cognitive symptoms (problem solving and memory), negative symptoms (motivation and socialization), or treatment-resistant symptoms in schizophrenia
- Studies of novel, state-of-the-art treatments
- Studies of brain anatomy and chemistry using EEG, MRI, MRS, or PET
- Electrophysiological and functional brain imaging evaluation of information processing and memory (e.g., the brain’s reaction to sensory stimulation and memory tasks)
In general, what may research participants be asked to do?
- Complete a physical exam (includes vital signs, blood draw, and urine collection for clinical laboratory tests, & drug test)
- Receive an experimental pharmaceutical treatment (in the form of a drug, digital therapy, brain stimulation, or placebo)
- Wear an EEG cap and undergo an EEG scan
- Undergo an MRI or PET scan
- Meet with a psychiatrist, psychologist, or staff member and answer questions (using standardized assessment tools [SCID-5 & PANSS]) about their schizophrenia symptoms and mood, as well as perform cognitive scales
- NOTE: Most, but not all, of our studies involve taking an experimental medication or placebo. We do sometimes have studies available that do not require a participant to take any experimental medication or placebo.
CONTACT US if you are interested in participating in and/or learning more about our research studies:
Interested individuals should call our recruitment staff at 646-774-8496. Initial phone discussions will focus on gathering basic information and answering questions to see which study would be a good fit. Individuals meeting criteria will be invited for an on-site screening interview to learn more about specific research studies of the Columbia Schizophrenia Research Center (CSRC).
Leadership Staff
Joshua Kantrowitz, MD
Director, Columbia Schizophrenia Research Center
New York State Psychiatric Institute
1051 Riverside Drive, Suite 1800
New York, NY 10032
Joshua.Kantrowitz@nyspi.columbia.edu
Megan Mayer, BA
Associate Director, Columbia Schizophrenia Research Center
New York State Psychiatric Institute
1051 Riverside Drive, Suite 1800
New York, NY 10032 Megan.Mayer@nyspi.columbia.edu
Current Clinical Trials
Treatment Studies:
ALTO Study (ALTO-101T)
Study Title: Double-Blind, Placebo-Controlled Study of ALTO-101T in Patients with Schizophrenia and Cognitive Impairment
Clinical Trial Link: https://clinicaltrials.gov/study/NCT06502964?term=alto-101t&rank=1
Brief Description: This is a Phase 2, double-blind, placebo-controlled, two-way crossover study to compare the efficacy of ALTO-101T versus placebo in changing EEG cognitive processing markers and cognition. Eligible participants will complete two inpatient treatment periods, each day with 10-day dosing with placebo TDS or ALTO-101T TDS administered in random order, double blind, with identical assessments and activities. A washout of 6 to 14 days will separate the two periods. The study involves procedures such as physical exams, electroencephalograms (EEG), blood and urine tests, urine drug screens, pregnancy tests (if applicable) and schizophrenia evaluations and interviews. Subjects will be compensated up to $2,500 for their participation in this study.
Alkermes Study (Olanzapine and Samidorphan)
Study Title: A Proof-of-Concept Study of Time Limited Exercise Plus Olanzapine and Samidorphan for the Prevention of Early Weight Gain
Clinical Trial Link: https://clinicaltrials.gov/study/NCT06740890?term=NCT06740890&rank=1
Brief Description: This is a single site trial for individuals with schizophrenia, schizoaffective, or bipolar I/II/NOS disorder. Eligible participants will receive eight weeks of olanzapine and samidorphan (Olz/Sam) plus four weeks of aerobic exercise. The study will assess whether using an FDA approved treatment (Olz/Sam) combined with an exercise program can help with weight loss for individuals diagnosed with schizophrenia, schizoaffective, or bipolar I/II/NOS disorder. The study involves procedures such as physical exams, electrocardiograms (ECGs), blood and urine tests, urine drug screens, pregnancy tests (if applicable) and schizophrenia evaluations and interviews. Subjects will be compensated up to $750 for their participation in this study.
BI-ENSPIRUS Study (CT-155)
Study Title: A Multicenter, Pragmatic Study to Evaluate Clinical Effectiveness of an Investigational Digital Therapeutic (CT-155) in Patients with Experiential Negative Symptoms of Schizophrenia
Clinical Trial Link: https://clinicaltrials.gov/study/NCT06791122?term=CT-155&rank=3
Brief Description: This is a multicenter, prospective study aimed to evaluate the clinical effectiveness and safety of CT-155, a novel investigational digital therapeutic, in adult patients diagnosed with schizophrenia. Enrolled participants will be asked to use the CT-155 app on their smartphone daily for 16 weeks and will be expected to visit the study site every 8 weeks. After the first 16 weeks, participants and their study investigator can decide to start a second 16-week course of study treatment using the app. Subjects will be compensated up to $1,105 for their participation in this study.
R33 Study (D-Serine)
Study Title: D-Serine Augmentation of Neuroplasticity-Based Auditory Learning in Schizophrenia
Clinical Trial Link: https://clinicaltrials.gov/ct2/show/NCT05046353(link is external and opens in a new window)
Brief Description: D-serine is a naturally occurring substance in the brain that activates the N-methyl-d-aspartate-type glutamate receptor (NMDAR). The study proposes that problems with the NMDAR receptor within the brain leads to impaired plasticity (learning), which in turn leads to impaired cognition associated with schizophrenia. This study trains subjects to improve their ability to distinguish between two tones that differ in pitch (sound frequency) and other auditory based learning programs (auditory remediation). Participants will be randomized to take either 100mg/kg of d-serine or placebo (1:1), and the effects will be assessed over 16 weekly sessions of auditory remediation. The study involves procedures such as physical exams, electroencephalograms (EEG), electrocardiograms (ECGs), blood and urine tests, urine drug screens, pregnancy tests (if applicable) and schizophrenia evaluations and interviews. Subjects will be compensated up to $1,475 for their participation in this study.
REVISIT C Study
Study Title: Clozapine for Prevention of Violence in Schizophrenia: a Randomized Clinical Trial
Clinical Trial Link: https://clinicaltrials.gov/ct2/show/NCT05208190(link is external and opens in a new window)
Brief Description: 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.
Healthy Volunteer Studies:
Ketamine (SA2)
Study Title: Glutamatergic mechanisms of psychosis and target engagement: Aim 2
Clinical Trial Link: https://clinicaltrials.gov/ct2/show/NCT05401227(link is external and opens in a new window)
Brief Description: This is a randomized, double-blind, and placebo-controlled study aiming to evaluate the relative sensitivity of low, medium, and high ketamine doses to effects of TS-134 and whether this sensitivity is related to baseline glutamate-DA levels. Healthy volunteers will be randomized to one of three ketamine arms: low, medium, and high. Within each ketamine arm, subjects will be randomized to 4 days of TS-134 20 mg or placebo in a 5:3 ratio. Following an outpatient Screening Period (up to 31 days), eligible subjects will undergo a 5-day inpatient Treatment Period. During the study, each subject will undergo a total of two ketamine sessions: a first session during the Screening Period and a second session on Day 4 of the Treatment Period, conducted at least 7 days apart. All randomized subjects will be dosed with TS-134 or placebo daily for 4 days. As before, subjects’ general health and safety status will be confirmed by a phone call following discharge from the Treatment Period. Subjects will be compensated a total of up to $1,550 for their participation in this 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 receive $50-$275 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 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 to participate in research?
Yes— all our clinical trials require participants to complete study visits in person at our clinic, which is located at 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, most visits will require the participant to be present in person.
What else does Columbia Schizophrenia Research Center offer?
After research participation, we offer up to 4 months of free clinical care for patients without external providers. Treatment services include: a full psychiatric evaluation and individual medication management visits with a clinical psychiatrist.
How long do the studies last?
Participation in our studies lasts anywhere from a few weeks to over 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 procedures 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.
