Once Weekly D-cycloserine for Schizophrenia
Primary Purpose
Schizophrenia
Status
Withdrawn
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
D-cycloserine
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia focused on measuring Cognitive Impairment, Neuroplasticity, D-cycloserine, N-methyl-D-aspartate (NMDA), Anti-Bacterial Agents, Mental Disorders, Psychotic Disorders, Antitubercular Agents, Schizophrenia and Disorders with Psychotic Features, Schizoaffective Disorder
Eligibility Criteria
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.
- Severe renal insufficiency (Serum creatinine > 1.5 mg/dL)
Sites / Locations
- Massachusetts General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
D-cycloserine
Placebo
Arm Description
Participants will receive D-cycloserine weekly, one hour before any assessments, for eight weeks.
Participants will receive placebo weekly, one hour before any assessments, for eight weeks.
Outcomes
Primary Outcome Measures
Effect of repeated weekly dosing of D-cycloserine on performance on a standard cognitive battery.
Secondary Outcome Measures
Effects of weekly D-cycloserine dosing on negative symptoms at weeks 4 & 8 compared to placebo.
Effect of a single dose of D-cycloserine 50 mg on memory consolidation as measured by the Logical Memory Test compared to placebo.
Assess the persistence of once-weekly D-cycloserine effects on memory consolidation measured at weeks 4 & 8.
Assess tolerability and side effects of weekly D-cycloserine compared to placebo
Full Information
NCT ID
NCT00964041
First Posted
August 20, 2009
Last Updated
November 19, 2013
Sponsor
Massachusetts General Hospital
Collaborators
National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT00964041
Brief Title
Once Weekly D-cycloserine for Schizophrenia
Official Title
Effects of Weekly Dosing of D-cycloserine on Cognitive Function in Individuals With Schizophrenia.
Study Type
Interventional
2. Study Status
Record Verification Date
November 2013
Overall Recruitment Status
Withdrawn
Study Start Date
July 2009 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
National Institute of Mental Health (NIMH)
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
In a previous placebo-controlled trial, investigators demonstrated significant improvement of negative symptoms with once-weekly D-cycloserine treatment. In addition, investigators found significant improvement of memory consolidation following the first dose; however, the effect on memory consolidation was lost after several weeks. The "practice effect" of weekly measurement of memory consolidation using repeated administration of the Logical Memory Test may have resulted in a "ceiling effect" which would obscure drug/placebo differences. In the current study, investigators propose to administer the Logical Memory Test at four-week intervals (weeks 1, 4 and 8) to avoid the ceiling effect. Additionally a measurement will be added of negative symptoms at week 4 to better characterize the time course of negative symptom improvement.
Hypotheses:
Assess the effects of a single dose of D-cycloserine 50 mg on memory consolidation as measured by the Logical Memory Test compared to placebo.
Assess the persistence of once-weekly D-cycloserine effects on memory consolidation measured at weeks 4 & 8.
Assess the effects of repeated weekly dosing of D-cycloserine on performance on a standard cognitive battery at week 8 compared to placebo.
Assess effects of weekly D-cycloserine dosing on negative symptoms at weeks 4 & 8 compared to placebo.
Assess tolerability and side effects of weekly D-cycloserine compared to placebo.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Cognitive Impairment, Neuroplasticity, D-cycloserine, N-methyl-D-aspartate (NMDA), Anti-Bacterial Agents, Mental Disorders, Psychotic Disorders, Antitubercular Agents, Schizophrenia and Disorders with Psychotic Features, Schizoaffective Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
D-cycloserine
Arm Type
Experimental
Arm Description
Participants will receive D-cycloserine weekly, one hour before any assessments, for eight weeks.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will receive placebo weekly, one hour before any assessments, for eight weeks.
Intervention Type
Drug
Intervention Name(s)
D-cycloserine
Other Intervention Name(s)
Seromycin, Cycloserine
Intervention Description
50 mg by mouth weekly, one hour before assessments, for eight weeks.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo by mouth, weekly, one hour before any assessments, each week for eight weeks.
Primary Outcome Measure Information:
Title
Effect of repeated weekly dosing of D-cycloserine on performance on a standard cognitive battery.
Time Frame
Baseline (Week 0) and End of Study (Week 8)
Secondary Outcome Measure Information:
Title
Effects of weekly D-cycloserine dosing on negative symptoms at weeks 4 & 8 compared to placebo.
Time Frame
Baseline (Week 0) and End of Study (Week 8)
Title
Effect of a single dose of D-cycloserine 50 mg on memory consolidation as measured by the Logical Memory Test compared to placebo.
Time Frame
Same Day (Single Dose - Week 1)
Title
Assess the persistence of once-weekly D-cycloserine effects on memory consolidation measured at weeks 4 & 8.
Time Frame
Week 4 and Week 8
Title
Assess tolerability and side effects of weekly D-cycloserine compared to placebo
Time Frame
Weekly measurements for 8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Severe renal insufficiency (Serum creatinine > 1.5 mg/dL)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Donald C Goff, M.D.
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Once Weekly D-cycloserine for Schizophrenia
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