Once Weekly D-cycloserine for Schizophrenia
Effects of Weekly Dosing of D-cycloserine on Cognitive Function in Individuals With Schizophrenia.
3 other identifiers
interventional
N/A
1 country
1
Brief Summary
This is a parallel-group, placebo-controlled trial examining the cognitive effects at weeks 1, 4, \& 8 of once-weekly oral D-cycloserine 50 mg added to a stable dose of antipsychotic for 8 weeks in adult outpatients with schizophrenia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Jul 2009
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2009
CompletedFirst Submitted
Initial submission to the registry
August 20, 2009
CompletedFirst Posted
Study publicly available on registry
August 24, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2011
CompletedNovember 20, 2013
November 1, 2013
1.9 years
August 20, 2009
November 19, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Effect of repeated weekly dosing of D-cycloserine on performance on a standard cognitive battery.
Baseline (Week 0) and End of Study (Week 8)
Secondary Outcomes (4)
Effects of weekly D-cycloserine dosing on negative symptoms at weeks 4 & 8 compared to placebo.
Baseline (Week 0) and End of Study (Week 8)
Effect of a single dose of D-cycloserine 50 mg on memory consolidation as measured by the Logical Memory Test compared to placebo.
Same Day (Single Dose - Week 1)
Assess the persistence of once-weekly D-cycloserine effects on memory consolidation measured at weeks 4 & 8.
Week 4 and Week 8
Assess tolerability and side effects of weekly D-cycloserine compared to placebo
Weekly measurements for 8 weeks
Study Arms (2)
D-cycloserine
EXPERIMENTALParticipants will receive D-cycloserine weekly, one hour before any assessments, for eight weeks.
Placebo
PLACEBO COMPARATORParticipants will receive placebo weekly, one hour before any assessments, for eight weeks.
Interventions
50 mg by mouth weekly, one hour before assessments, for eight weeks.
Placebo by mouth, weekly, one hour before any assessments, each week for eight weeks.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
- Severe renal insufficiency (Serum creatinine \> 1.5 mg/dL)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Donald C Goff, M.D.
Massachusetts General Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of the Schizophrenia Clinical and Research Program
Study Record Dates
First Submitted
August 20, 2009
First Posted
August 24, 2009
Study Start
July 1, 2009
Primary Completion
June 1, 2011
Study Completion
June 1, 2011
Last Updated
November 20, 2013
Record last verified: 2013-11