D-cycloserine Augmentation of Cognitive Remediation in Schizophrenia
| Status: | Completed |
|---|---|
| Conditions: | Schizophrenia |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 2/8/2018 |
| Start Date: | August 2009 |
| End Date: | June 2011 |
A Placebo-controlled Trial of D-cycloserine Augmentation of Cognitive Remediation in Schizophrenia
This study seeks to examine the effects of D-cycloserine augmentation on cognitive
remediation for patients diagnosed with schizophrenia. We will test the hypotheses that
D-cycloserine will significantly improve cognitive performance, negative symptoms, and
measures of functioning compared to placebo when combined with eight weeks of cognitive
remediation. We expect that these effects will persist when assessed at six-month follow up.
remediation for patients diagnosed with schizophrenia. We will test the hypotheses that
D-cycloserine will significantly improve cognitive performance, negative symptoms, and
measures of functioning compared to placebo when combined with eight weeks of cognitive
remediation. We expect that these effects will persist when assessed at six-month follow up.
D-cycloserine has been shown to enhance learning in animal models and, in a previous trial,
once-weekly D-cycloserine improved negative symptoms in schizophrenia subjects. We set out to
test whether DCS combined with cognitive remediation would improve learning of a practiced
auditory discrimination task and whether gains would generalize to unpracticed cognitive
tasks.
The proposed study consists of an 8-week, placebo-controlled, double-blind, parallel-group
trial of D-cycloserine augmentation of cognitive remediation in schizophrenia outpatients.
The primary outcome measure is change in performance on the MATRICS cognitive battery
composite score after 8 weeks. Secondary outcome measures include a measure of processing
speed assessed after weeks 1, 2, 4 & 8, and changes in negative symptoms and measures of
functioning after 4 and 8 weeks. In addition, all outcome measures will be repeated at 6
months to assess persistence of benefit.
Hypotheses:
1. D-cycloserine will significantly improve cognitive performance as measured by the
composite score on the MATRICS battery compared to placebo after 8 weeks of cognitive
remediation.
2. D-cycloserine will significantly improve negative symptoms as measured by the SANS
compared to placebo after 8 weeks when combined with cognitive remediation.
3. D-cycloserine will significantly improve measures of functioning (GAS, QoL and CGI) at 8
weeks compared to placebo when combined with cognitive remediation.
4. D-cycloserine effects on cognition, negative symptoms and functioning will persist
compared to placebo when assessed at 6-month follow-up.
once-weekly D-cycloserine improved negative symptoms in schizophrenia subjects. We set out to
test whether DCS combined with cognitive remediation would improve learning of a practiced
auditory discrimination task and whether gains would generalize to unpracticed cognitive
tasks.
The proposed study consists of an 8-week, placebo-controlled, double-blind, parallel-group
trial of D-cycloserine augmentation of cognitive remediation in schizophrenia outpatients.
The primary outcome measure is change in performance on the MATRICS cognitive battery
composite score after 8 weeks. Secondary outcome measures include a measure of processing
speed assessed after weeks 1, 2, 4 & 8, and changes in negative symptoms and measures of
functioning after 4 and 8 weeks. In addition, all outcome measures will be repeated at 6
months to assess persistence of benefit.
Hypotheses:
1. D-cycloserine will significantly improve cognitive performance as measured by the
composite score on the MATRICS battery compared to placebo after 8 weeks of cognitive
remediation.
2. D-cycloserine will significantly improve negative symptoms as measured by the SANS
compared to placebo after 8 weeks when combined with cognitive remediation.
3. D-cycloserine will significantly improve measures of functioning (GAS, QoL and CGI) at 8
weeks compared to placebo when combined with cognitive remediation.
4. D-cycloserine effects on cognition, negative symptoms and functioning will persist
compared to placebo when assessed at 6-month follow-up.
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
- Able to perform the cognitive remediation exercises
Exclusion Criteria:
- Current treatment with clozapine
- Dementia
- Seizure disorder
- Unstable medical illness
- Renal insufficiency measured as eGFR >60mg/dL/min
- Active substance abuse: positive urine toxic screen
- Pregnancy, nursing, or unwilling to use appropriate birth control measures during
participation if female and fertile.
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