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Sponsored by: |
Massachusetts General Hospital |
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Information provided by: | Massachusetts General Hospital |
ClinicalTrials.gov Identifier: | NCT00455702 |
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.
Condition | Intervention | Phase |
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Schizophrenia |
Drug: d-cycloserine |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Effects of Weekly Dosing of D-Cycloserine on Cognitive Function in Individuals |
Enrollment: | 50 |
Study Start Date: | July 2004 |
Study Completion Date: | September 2008 |
Primary Completion Date: | April 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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D-cycloserine: Experimental
50 mg d-cycloserine
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Drug: d-cycloserine
50mg dose d-cycloserine v placebo
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Placebo: Placebo Comparator |
Drug: d-cycloserine
50mg dose d-cycloserine v placebo
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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:
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Massachusetts | |
Massachusetts General Hospital | |
Boston, Massachusetts, United States, 02114 |
Principal Investigator: | Donald C Goff, M.D. | Massachusetts General Hospital |
Responsible Party: | Massachusetts General Hospital ( Donald Goff, MD ) |
Study ID Numbers: | 2005-P-001040 |
Study First Received: | April 2, 2007 |
Last Updated: | February 27, 2009 |
ClinicalTrials.gov Identifier: | NCT00455702 History of Changes |
Health Authority: | United States: Institutional Review Board |
schizophrenia cognition d-cycloserine memory |
Antimetabolites Cycloserine Schizophrenia Anti-Bacterial Agents Anti-Infective Agents |
Mental Disorders Anti-Infective Agents, Urinary Psychotic Disorders Antitubercular Agents Schizophrenia and Disorders with Psychotic Features |
Cycloserine Antimetabolites Anti-Infective Agents Molecular Mechanisms of Pharmacological Action Anti-Infective Agents, Urinary Renal Agents Pharmacologic Actions |
Antibiotics, Antitubercular Schizophrenia Anti-Bacterial Agents Mental Disorders Therapeutic Uses Antitubercular Agents Schizophrenia and Disorders with Psychotic Features |