| April 2, 2007 |
| February 27, 2009 |
| 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 total score and on a composite cognitive score. [ Time Frame: 8 Weeks ] [ Designated as safety issue: No ] |
| Same as current |
| Complete list of historical versions of study NCT00455702 on ClinicalTrials.gov Archive Site |
- comparisons of treatment effects on the Positive Syndrome Subscale of the PANSS and CGI global improvement score at week 8 [ Time Frame: 8 Weeks ] [ Designated as safety issue: No ]
- change from baseline at the first repeat administration of the Logical Memory Test (immediate recall tested at week 1 and delayed recall tested at week 2) [ Time Frame: 1 week ] [ Designated as safety issue: No ]
|
| Same as current |
| |
| 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:
- Assess the effects of a single dose of D-cycloserine 50 mg on cognitive functioning compared to placebo.
- Assess the effects of repeated weekly dosing of D-cycloserine on cognitive functioning at week 8 compared to placebo.
- Assess the effects of repeated weekly dosing of D-cycloserine on memory functioning once a week 1 hour after medication administration compared to placebo.
- 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.
- Assess effects of weekly D-cycloserine dosing on positive & negative symptoms at week 8 compared to placebo.
- Assess tolerability and side effects of weekly D-cycloserine compared to placebo.
- Assess the effects of d-cycloserine dosed weekly for seven weeks on reward responsiveness as measured with the response bias task compared with placebo.
- Assess the effects of d-cycloserine dosed weekly for seven weeks on measures of functioning.
|
| Phase IV |
| Interventional |
| Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Schizophrenia |
| Drug: d-cycloserine |
| Experimental: 50 mg 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. |
| |
| Completed |
| 50 |
| September 2008 |
| April 2007 (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
Exclusion Criteria:
- Current treatment with clozapine
- Dementia
- Seizure disorder
- Unstable medical illness
- Active substance abuse
- 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 |
| Donald Goff, MD, Massachusetts General Hospital |
| 2005-P-001040 |
| Massachusetts General Hospital |
|
| Principal Investigator: |
Donald C Goff, M.D. |
Massachusetts General Hospital |
|
|
| Massachusetts General Hospital |
| February 2009 |