D-serine for the Schizophrenia Prodrome
Condition: Schizophrenia Prodrome
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 2

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 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.
    


Intervention name(s): D-serine; Placebo
Intervention type(s): Drug; Other
Intervention description(s): 60 mg/kg/day; Inert Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: schizophrenia; d-serine; prodrome