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Sponsors and Collaborators: |
Nathan Kline Institute for Psychiatric Research Yale University The Zucker Hillside Hospital National Institute of Mental Health (NIMH) |
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Information provided by: | Nathan Kline Institute for Psychiatric Research |
ClinicalTrials.gov Identifier: | NCT00826202 |
The purpose of the study is to determine the safety and efficacy of D-serine as an early intervention treatment for the schizophrenia prodrome condition. This study is a placebo-controlled trial of D-serine in the symptomatic treatment of patients with the schizophrenia prodrome. Seventy two subjects meeting criteria for the schizophrenia prodrome will be included in this study, 24 at each site (Yale, Nathan Kline Institute and Zucker Hillside Hospital). The primary outcome measures will include symptom and neuropsychological measures. The duration of this study is two and a half years. This research with D-serine holds out the prospect of direct benefit for the patient's current symptoms.
Subjects may also benefit from the close monitoring of their symptoms, so that, if schizophrenic psychosis does occur, the psychosis will be recognized and treatment may begin with minimal delay. This study also could be of benefit by suggesting a promising lead in early intervention in the schizophrenic prodrome.
Overall Design Summary. We propose for prodromal patients to be randomized to D-serine vs placebo for 16 weeks.
To insure that all subjects have the opportunity to receive D-serine, there will be an optional 16 week cross-over trial on the alternate study medication. No subject will be on D-serine for longer than 16 weeks.
Admission criteria, Assessment Procedures, and Study Design will be the same across all sites. The procedures and timeline are shown in Table 1. The procedures and timeline are the same for the initial randomized 16 week trial and the optional cross-over trial on the alternate study medication. If patient's opt for the 16 week treatment on the alternate medication, we will use their assessments from end of initial treatment as baseline for 16 week treatment on alternate medication. Subjects will be seen for two preliminary visits, then once in treatment, subjects will be seen weekly for the first 5 visits then biweekly thereafter. A safety blood and urine collection will be done on day 3 (3 days after the start of study medication). Vital signs and weight, blood draw and urine collection for safety measures, urine pregnancy test and urine for toxicology will be repeated throughout treatment. Adverse effects ratings and symptom assessments will be repeated at each visit.
Neuropsychological assessment and optional "Biomarker study" visual, auditory and ERPs tasks will be administered during one of the two preliminary visits then again at study endpoint. Any patients who convert to frank psychosis will be referred/offered immediate treatment.
Condition | Intervention | Phase |
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Schizophrenia Prodrome |
Drug: D-serine Other: Placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | D-Serine vs Placebo for the Schizophrenia Prodrome |
Estimated Enrollment: | 72 |
Study Start Date: | March 2009 |
Estimated Study Completion Date: | June 2011 |
Estimated Primary Completion Date: | June 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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D serine: Experimental
60 mg/kg/day
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Drug: D-serine
60 mg/kg/day
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Placebo: Placebo Comparator |
Other: Placebo
Inert Placebo
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Ages Eligible for Study: | 13 Years to 35 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion criteria:
Exclusion criteria:
For adolescents (ages 13-17), more stringent renal exclusion criteria will be adhered to:
Schizophrenia Prodrome Criteria:
We will be enrolling both Attenuated Positive Syndrome (APS) [1], Genetic Familial Risk (GFR) [1] and Clinically High Risk Negative (CHR-) symptom prodromes to this study. A separate analysis will be done for the APS and CHR- patients.
Genetic Familial Risk: First degree relative with history of any psychotic disorder OR Criteria for schizotypal personality disorder met in patient AND GAF drop of at least 30% over the last month vs 1 year ago.
In our experience, very few patients only meet criteria for this syndrome.
Contact: Gail Silipo, MS | 845-398-6536 | silipo@nki.rfmh.org |
United States, Connecticut | |
Yale University | Recruiting |
New Haven, Connecticut, United States | |
Contact: John Saksa, PsyD 203-974-7043 john.saksa@yale.edu | |
Principal Investigator: Scott Woods, MD | |
United States, New York | |
Nathan Kline Institute | Not yet recruiting |
Orangeburg, New York, United States, 10962 | |
Contact: Gail Silipo, MS 845-398-6536 silipo@nki.rfmh.org | |
Principal Investigator: Daniel C Javitt, MD, Phd | |
Sub-Investigator: Joshua T Kantrowitz, MD | |
Zucker Hillside Hospital | Not yet recruiting |
Glen Oaks, New York, United States | |
Contact: Andrea Auther, PhD AAuther@LIJ.EDU | |
Principal Investigator: Barbara Cornblatt, PhD | |
Sub-Investigator: Andrea Auther, PhD |
Principal Investigator: | Daniel C Javitt, MD, PhD | Nathan Kline Institute for Psychiatric Research |
Responsible Party: | Nathan Kline Institute ( Daniel Javitt MD ) |
Study ID Numbers: | 08I/C33, CDDG 1 U01 MH074356-01 |
Study First Received: | January 21, 2009 |
Last Updated: | May 21, 2009 |
ClinicalTrials.gov Identifier: | NCT00826202 History of Changes |
Health Authority: | United States: Food and Drug Administration |
schizophrenia d-serine prodrome |
Schizophrenia Mental Disorders Psychotic Disorders Serine Schizophrenia and Disorders with Psychotic Features |
Schizophrenia Mental Disorders Schizophrenia and Disorders with Psychotic Features |