D-cycloserine Augmentation of Cognitive Remediation in Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional

Summary: 
      This study seeks to examine the effects of D-cycloserine augmentation on cognitive
      remediation for patients diagnosed with schizophrenia. We will test the hypotheses that
      D-cycloserine will significantly improve cognitive performance, negative symptoms, and
      measures of functioning compared to placebo when combined with eight weeks of cognitive
      remediation. We expect that these effects will persist when assessed at six-month follow up.
    

Detailed description: 
      D-cycloserine has been shown to enhance learning in animal models and, in a previous trial,
      once-weekly D-cycloserine improved negative symptoms in schizophrenia subjects. We set out to
      test whether DCS combined with cognitive remediation would improve learning of a practiced
      auditory discrimination task and whether gains would generalize to unpracticed cognitive
      tasks.

      The proposed study consists of an 8-week, placebo-controlled, double-blind, parallel-group
      trial of D-cycloserine augmentation of cognitive remediation in schizophrenia outpatients.
      The primary outcome measure is change in performance on the MATRICS cognitive battery
      composite score after 8 weeks. Secondary outcome measures include a measure of processing
      speed assessed after weeks 1, 2, 4 & 8, and changes in negative symptoms and measures of
      functioning after 4 and 8 weeks. In addition, all outcome measures will be repeated at 6
      months to assess persistence of benefit.

      Hypotheses:

        1. D-cycloserine will significantly improve cognitive performance as measured by the
           composite score on the MATRICS battery compared to placebo after 8 weeks of cognitive
           remediation.

        2. D-cycloserine will significantly improve negative symptoms as measured by the SANS
           compared to placebo after 8 weeks when combined with cognitive remediation.

        3. D-cycloserine will significantly improve measures of functioning (GAS, QoL and CGI) at 8
           weeks compared to placebo when combined with cognitive remediation.

        4. D-cycloserine effects on cognition, negative symptoms and functioning will persist
           compared to placebo when assessed at 6-month follow-up.
    

Intervention name(s): D-cycloserine; Placebo; Cognitive Remediation
Intervention type(s): Drug; Drug; Behavioral
Intervention description(s): 50 mg by mouth one hour before first cognitive remediation session each week for eight weeks.; Placebo by mouth one hour before first cognitive remediation session each week for eight weeks.; 40 one-hour daily sessions of cognitive remediation (Brain Fitness Program) over eight weeks.
Other intervention name(s): Cycloserine; Brain Fitness Program
Intervention MeSH terms: Cycloserine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cognitive Impairment; Neuroplasticity; D-cycloserine; NMDA; Anti-Bacterial Agents; Mental Disorders; Psychotic Disorders; Antitubercular Agents; Schizophrenia and Disorders with Psychotic Features; Schizoaffective Disorder