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 and trained research scientists, and other staff. 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 and individual medication management visits with a clinical psychiatrist. 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 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 a number of 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 and individual medication management visits with a clinical psychiatrist)— all free of charge. Medications administered as part of research procedures are free of cost. However, we cannot cover the cost of medications patients are taking outside of our research. Once the research study is completed, we will make an outside referral for continued patient care. 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 or devices 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, urine screen, & drug test)
- Take an experimental pharmaceutical treatment (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 their 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 Tala Berro at 646-774-8496. 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).
Current Clinical Trials
Placebo-Controlled Treatment Studies:
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
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.
D1 Study (CVL-562)
Study Title: A Translational and Neurocomputational Evaluation of a D1R Partial Agonist for Schizophrenia
Clinical Trial Link: https://clinicaltrials.gov/ct2/show/NCT04457310
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 CVL-562 (a dopamine-1 receptor partial agonist) in outpatient subjects aged 18-45 who are within 10 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 during their participation in the trial. Subjects will be compensated up to $2,910 for their participation in this study.
CIAS ERUDITE Study (luvadaxistat)
Study Title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy, Safety, and Tolerability of Luvadaxistat in Subjects With Cognitive Impairment Associated With Schizophrenia, Followed by Open-Label Treatment
Clinical Trial Link: https://clinicaltrials.gov/ct2/show/NCT05182476
Brief Description: This is a randomized, double-blind, parallel, placebo-controlled study with a 6-12-month open-label extension. The study is designed to evaluate the efficacy, safety and tolerability, and pharmacokinetics (PK) of treatment with luvadaxistat on improving symptoms of cognitive impairment associated with schizophrenia (CIAS) in adult subjects with schizophrenia. In addition, the study will evaluate the long-term safety and tolerability of treatment with luvadaxistat. Eligible subjects will be randomized (1:1:2) to receive luvadaxistat 20 mg, luvadaxistat 50 mg, or placebo orally QD during the 14-week Double-Blind Treatment Period. Subsequently, all subjects who complete the Double-Blind Treatment Period and who are continuing to take study treatment will enter the 6-12-month Open-Label Treatment Period and receive luvadaxistat 50 mg QD. A final Safety Follow-Up Visit will be conducted approximately 2 weeks after the final dose of study treatment (Day 476 [Visit 21]). Subjects will be compensated up to $3,925 for their participation in this study.
BI12 Study (CONNEX-2, Iclepertin)
Study Title: A phase III randomized, double-blind, placebo-controlled, parallel group trial to examine the efficacy and safety of Iclepertin once daily over a 26-week treatment period in patients with schizophrenia (CONNEX)
Clinical Trial Link: https://clinicaltrials.gov/ct2/show/NCT04846881
Brief Description: The purpose of BI12 is to assess the efficacy in improving cognitive impairment associated with schizophrenia (CIAS) in clinically stable outpatients. Participants will be randomized in equal ratio to either Iclepertin 10mg or placebo. The study consists of 3 periods: Screening Period (up to 5 weeks), Randomized Treatment Period (26 weeks) and Safety Follow up Period (4 weeks). 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 who complete the full study will be offered the opportunity to enroll in a one year extension. Subjects will be compensated up to $2,700 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
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.
Click Study (Digital Therapeutics)
Study Title: Study to Evaluate the Efficacy and Safety of a Digital Therapeutic as an Adjunct to Standard-of-Care Antipsychotic Therapy in Adult and Late Adolescent Participants with Experiential Negative Symptoms of Schizophrenia
Clinical Trial Link: https://www.clinicaltrials.gov/ct2/show/NCT05838625
Brief Description: This is a multicenter, randomized, double-blind 16-week study to evaluate the efficacy and safety of two investigational digital therapeutics. An investigational digital therapeutic is a mobile software application that is being studied for approval by the United States (US) Food and Drug Administration (FDA). In this study, people with schizophrenia (participants) will be assigned to use one of the two digital therapeutics (Study App). Participants will be asked to use the Study App for 16 weeks. Before, during, and after those 16 weeks, participants will be asked questions about their physical and mental health, and the symptoms of schizophrenia they are experiencing. Subjects will be compensated up to $475 for their participation in this study.
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. Subjects will be compensated up to $290 for their participation in this study.
Healthy Volunteer Studies:
Study Title: Glutamatergic mechanisms of psychosis and target engagement: Aim 2
Clinical Trial Link: https://clinicaltrials.gov/ct2/show/NCT05401227
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 recieve $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 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 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 last sanywhere 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 Tala Berro at 646-774-8496.