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Phase 3 N=55 Randomized Double-blind Treatment

Trial of D-Cycloserine in Schizophrenia

Schizophrenia

Enrolled (actual)
55
Serious AEs
Results posted
Sep 2014
Primary outcome: Primary: Scale for the Assessment of Negative Symptoms (SANS) — -.46; -.41 units on a scale/weeks

Study Design & Population

Study type
Interventional
Phase
Phase 3
Interventions
D-cycloserine (Drug); Placebo (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Massachusetts General Hospital
Primary completion
Apr 2002

Outcome Measures

OutcomeResultp-value
PRIMARY
Scale for the Assessment of Negative Symptoms (SANS)
-.46; -.41

Summary

To characterize further the effects of D-cycloserine augmentation of antipsychotic treatment on negative symptoms, performance on neurocognitive tasks, and on markers for glutamatergic, dopaminergic and serotonergic function in serum and cerebrospinal fluid. To determine if negative symptoms and cognitive function improve over time, if these improvements meaningfully impact quality of life factors, if they correlate with markers of neuronal function, and if subpopulations can be identified according to response. Dysfunction of glutamatergic neuronal systems has recently been implicated in the pathophysiology of schizophrenia based on the finding that non-competitive inhibitors of the NMDA receptor can reproduce in normals the positive symptoms, negative symptoms, and cognitive deficits of schizophrenia. Furthermore, glutamatergic dysfunction may alter forebrain dopaminergic neuronal activity, a system central to the antipsychotic action of typical neuroleptics. It is believed that enhancing NMDA receptor function by systemic treatment with D-cycloserine, a partial agonist at the glycine modulatory site of the NMDA receptor, will reduce symptoms in schizophrenia. Sixty schizophrenic outpatients with prominent, primary negative symptoms are treated with antipsychotic medication and are randomly assigned to D-cycloserine or placebo for a 6-month, fixed-dose trial. The primary outcome measure is the total score on the Scale for Assessment of Negative Symptoms (SANS). A neuropsychological battery, which emphasizes tests sensitive to prefrontal cortical function, is administered. Blood is obtained at several time points and CSF is obtained at Week 8 for assay of concentrations of D-cycloserine, glutamate, HVA, and 5HIAA.

Eligibility Criteria

Inclusion Criteria

  • Diagnosis of Schizophrenia as per DSM IV criteria
  • Have been treated for at least 6 months with any conventional neuroleptic
  • Have prominent negative symptoms as defined by a total score of 40 or greater on the scale for the assessment of negative symptoms (SANS)

Exclusion Criteria

  • Active alcohol or drug abuse
  • Unstable Medical Illness, seizure disorder, or other serious neurological disorder
  • Pregnant or Nursing
  • Unable to complete a cognitive battery
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00000371). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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