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NCT00826202 · ClinicalTrials.gov registry record · Phase 2
D-serine for the Schizophrenia Prodrome
A Phase 2 study, sponsored by Nathan Kline Institute for Psychiatric Research.
- Completed
- Registry status
- Phase 2
- Development phase
- 44
- Enrollment target
NCT00826202 is a Phase 2 study that has completed, run by Nathan Kline Institute for Psychiatric Research. The registered enrollment target is 44 participants.
The verdict
NCT00826202, a Phase 2 study, has completed, sponsored by Nathan Kline Institute for Psychiatric Research.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 44 participants
- Enrollment target
Study Summary
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
Interventions
- OTHER Placebo
- DRUG D-serine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 44 participants |
| Start Date | 2009-03 |
| Est. Completion | 2012-11 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00826202
The ClinicalTrials.gov registry entry for NCT00826202 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 44 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Nathan Kline Institute for Psychiatric Research, which has 20 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00826202 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00826202 about?
NCT00826202 is a clinical study titled "D-serine for the Schizophrenia Prodrome". 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 subject...
What is the current status of trial NCT00826202?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 44 participants. The study started on 2009-03. Estimated completion is 2012-11.
What interventions are being tested in trial NCT00826202?
The interventions under investigation include: Placebo (OTHER), D-serine (DRUG).
Who is sponsoring clinical trial NCT00826202?
This trial is sponsored by Nathan Kline Institute for Psychiatric Research, which has 20 total clinical trials registered on ClinicalTrials.gov.
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