D-cycloserine Augmentation of Cognitive Remediation in Schizophrenia

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2009 by National Institute of Mental Health (NIMH).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:
NCT00963924
First received: August 20, 2009
Last updated: NA
Last verified: August 2009
History: No changes posted

August 20, 2009
August 20, 2009
August 2009
May 2011   (final data collection date for primary outcome measure)
Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) [ Time Frame: Weeks 0 and 8, and Month 6 after cognitive remediation completion ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
  • Positive and Negative Syndrome Scale (PANSS) [ Time Frame: Weeks 0, 4 and 8, and Month 6 after cognitive remediation completion ] [ Designated as safety issue: No ]
  • Scale for Assessment of Negative Symptoms (SANS) [ Time Frame: Weeks 0, 4 and 8, and Month 6 after cognitive remediation completion ] [ Designated as safety issue: No ]
  • Global Assessment Scale (GAS) [ Time Frame: Weeks 0, 4 and 8, and Month 6 after cogntive remediation completion ] [ Designated as safety issue: No ]
  • Heinrich Quality of Life Scale (QoL) [ Time Frame: Weeks 0, 4 and 8, and Month 6 after cognitive remediation completion ] [ Designated as safety issue: No ]
  • Calgary Depression Scale for Schizophrenia (CDSS) [ Time Frame: Weeks 0, 4 and 8, and Month 6 after cognitive remediation completion ] [ Designated as safety issue: No ]
  • Clinical Global Impression (CGI) [ Time Frame: Weeks 0 and 8, and Month 6 after cogntive remediation completion ] [ Designated as safety issue: No ]
  • Side Effects Checklist (SEC) [ Time Frame: Weeks 0 - 8, and Month 6 after cogntive remediation completion ] [ Designated as safety issue: Yes ]
  • Brain Fitness Program Processing Speed Assessment [ Time Frame: Weeks 0, 1, 2, 4 and 8 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
D-cycloserine Augmentation of Cognitive Remediation in Schizophrenia
A Placebo-controlled Trial of D-cycloserine Augmentation of Cognitive Remediation in Schizophrenia

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.

We propose to conduct an 8-week, placebo-controlled, double-blind, parallel-group trial of D-cycloserine augmentation of cognitive remediation in 80 stable 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.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Schizophrenia
  • Drug: D-cycloserine
    50 mg by mouth one hour before first cognitive remediation session each week for eight weeks.
    Other Name: Cycloserine
  • Drug: Placebo
    Placebo by mouth one hour before first cognitive remediation session each week for eight weeks.
  • Behavioral: Cognitive Remediation
    40 one-hour daily sessions of cognitive remediation (Brain Fitness Program) over eight weeks.
    Other Name: Brain Fitness Program
  • Experimental: D-cycloserine
    Participants will receive D-cycloserine weekly, one hour before the first cognitive remediation session of the week, for eight weeks.
    Interventions:
    • Drug: D-cycloserine
    • Behavioral: Cognitive Remediation
  • Placebo Comparator: Placebo
    Participants will receive placebo weekly, one hour before the first cognitive remediation session of the week, for eight weeks.
    Interventions:
    • Drug: Placebo
    • Behavioral: Cognitive Remediation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
120
June 2011
May 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male or female
  • Age 18-65 years
  • Diagnosis of schizophrenia or schizoaffective disorder, depressed type
  • Stable dose of antipsychotic for at least 4 weeks
  • Able to provide informed consent
  • Able to complete a cognitive battery
  • Able to perform the cognitive remediation exercises

Exclusion Criteria:

  • Current treatment with clozapine
  • Dementia
  • Seizure disorder
  • Unstable medical illness
  • Renal insufficiency measured as eGFR >60mg/dL/min
  • Active substance abuse: positive urine toxic screen
  • Pregnancy, nursing, or unwilling to use appropriate birth control measures during participation if female and fertile.
Both
18 Years to 65 Years
No
Contact: Timothy B. Creedon, B.A. 617-912-7864 tcreedon@partners.org
Contact: Lisa H. Raeke, M.A. 617-912-7840 lraeke@partners.org
United States
 
NCT00963924
2008P002237, 5P50 MH060450, DATR A3-NSC
No
Donald C. Goff, M.D., Massachusetts General Hospital
National Institute of Mental Health (NIMH)
Not Provided
Principal Investigator: Donald C. Goff, M.D. Massachusetts General Hospital
National Institute of Mental Health (NIMH)
August 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP