Effects of Weekly Dosing of D-cycloserine on Cognitive Function in Individuals With Schizophrenia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Donald C. Goff, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00455702
First received: April 2, 2007
Last updated: July 14, 2014
Last verified: July 2014

April 2, 2007
July 14, 2014
July 2004
April 2007   (final data collection date for primary outcome measure)
Main Outcome Measure: The Change From Baseline to Week 8 on the SANS [ Time Frame: Baseline score vs. Week 8 ] [ Designated as safety issue: No ]
The change from baseline to week 8 on the scale for the assessment of negative symptoms (SANS) total score. Total SANS scores range from 0-100. The SANS is comprised of 5 subscores: Affective Flattening or Blunting (score range 0-35), Alogia (score range 0-20), Avolition-Apathy (score range 0-15), Anhedonia-Asociality (score range 0-20), and Attention (0-10). For each scale, the higher the score the more prominent the negative symptoms were. The total score was computed by adding all the subscale total scores. To compute change in scores, week 8 scores were subtracted from baseline scores, resulting in a change score. Higher values equals greater improvement (i.e. week 8 score was lower than baseline score).
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Complete list of historical versions of study NCT00455702 on ClinicalTrials.gov Archive Site
Treatment Effects on the Positive Syndrome Subscale of the PANSS [ Time Frame: Baseline score vs. Week 8 score ] [ Designated as safety issue: No ]
The change from baseline to week 8 on the positive symptom sub-scale of the Positive and Negative Syndrome Scale (PANSS). Total PANSS positive symptom sub-scale scores range from 7-49. The PANSS positive symptom sub-scale is comprised of 7 items rated on a scale of 1-7: delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, and hostility. A score of one on each item 1 absent, 2 is minimal, 3 is mild, 4 is moderate, 5 is moderately severe, 6 is severe, and 7 is extreme. The total score was computed by adding all the items on the sub-scale together. To compute change in scores, week 8 scores were subtracted from baseline scores, resulting in a change score. Higher values equals greater improvement (i.e. week 8 score was lower than baseline score).
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Effects of Weekly Dosing of D-cycloserine on Cognitive Function in Individuals With Schizophrenia
Effects of Weekly Dosing of D-cycloserine on Cognitive Function in Individuals

The study aims to assess the effects of single dose and repeated weekly dosing of 50mg d-cycloserine versus placebo on cognitive and memory functioning in schizophrenia patients. The study will also examine the effects of 50mg d-cycloserine on positive symptoms and negative symptoms, as well as assess tolerability and side-effects.

This is a ten-week, parallel-group, placebo-controlled trial examining the cognitive effects at weeks 1, 2, 3. 4, 5, 6, 7, 8 & 10 of once-weekly oral D-cycloserine 50 mg added to a stable dose of antipsychotic for 8 weeks in 60 adult outpatients with schizophrenia.

Specific aims:

  1. Assess the effects of a single dose of D-cycloserine 50 mg on cognitive functioning compared to placebo.
  2. Assess the effects of repeated weekly dosing of D-cycloserine on cognitive functioning at week 8 compared to placebo.
  3. Assess the effects of repeated weekly dosing of D-cycloserine on memory functioning once a week 1 hour after medication administration compared to placebo.
  4. Assess the persistence of learned information in a no-treatment follow-up assessment at Week 10 in the D-cycloserine group compared to the placebo group.
  5. Assess effects of weekly D-cycloserine dosing on positive & negative symptoms at week 8 compared to placebo.
  6. Assess tolerability and side effects of weekly D-cycloserine compared to placebo.
  7. Assess the effects of d-cycloserine dosed weekly for seven weeks on reward responsiveness as measured with the response bias task compared with placebo.
  8. Assess the effects of d-cycloserine dosed weekly for seven weeks on measures of functioning.
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Schizophrenia
Drug: d-cycloserine
50mg dose d-cycloserine v placebo
  • Experimental: D-cycloserine
    50 mg d-cycloserine
    Intervention: Drug: d-cycloserine
  • Placebo Comparator: Placebo
    50 mg placebo
    Intervention: Drug: d-cycloserine
Goff DC, Cather C, Gottlieb JD, Evins AE, Walsh J, Raeke L, Otto MW, Schoenfeld D, Green MF. Once-weekly D-cycloserine effects on negative symptoms and cognition in schizophrenia: an exploratory study. Schizophr Res. 2008 Dec;106(2-3):320-7. Epub 2008 Sep 16.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
38
April 2007
April 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Male or female
  2. Age 18-65 years
  3. Diagnosis of schizophrenia or schizoaffective disorder, depressed type
  4. Stable dose of antipsychotic for at least 4 weeks.
  5. Able to provide informed consent
  6. Able to complete a cognitive battery

Exclusion Criteria:

  1. Current treatment with clozapine
  2. Dementia
  3. Seizure disorder
  4. Unstable medical illness
  5. Active substance abuse
  6. Pregnancy, nursing, or unwilling to use appropriate birth control measures during participation if female and fertile.
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00455702
2005-P-001040
No
Donald C. Goff, MD, Massachusetts General Hospital
Massachusetts General Hospital
Not Provided
Principal Investigator: Donald C Goff, M.D. Massachusetts General Hospital
Massachusetts General Hospital
July 2014

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