N/A
Completed N=36
D-cycloserine Augmentation of Cognitive Remediation in Schizophrenia
Source: ClinicalTrials.gov NCT00963924 ↗Enrolled (actual)
36
Serious AEs
2.8%
Results posted
Aug 2014
Primary outcomePrimary: Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) — 32.1; 33.0; 32.24; 33.8 t-scores
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) |
32.1; 33.0; 32.24; 33.8 | — |
| PRIMARY Scale for Assessment of Negative Symptoms (SANS) |
24.6; 25.8; 22.41; 24.67 | — |
| PRIMARY Auditory Discrimination Task: Interstimulus Interval (ISI) |
163.5; 124.8; 91.7; 127.9 | — |
| SECONDARY Positive and Negative Syndrome Scale (PANSS) |
61.8; 64.1 | — |
| SECONDARY Global Assessment of Functioning Scale (GAS) |
53.7; 50.8 | — |
| SECONDARY Heinrich Quality of Life Scale (QoL) |
71.8; 71.4 | — |
| SECONDARY Calgary Depression Scale for Schizophrenia (CDSS) |
2.8; 3.4 | — |
| SECONDARY Clinical Global Impression (CGI) |
3.78; 3.78; 3.65; 3.73; 4.00; 3.25 | — |
| SECONDARY Side Effects Checklist (SEC) |
1; 0; 17; 18; 0; 3 | — |
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
- 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.
Data sourced from ClinicalTrials.gov (NCT00963924). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.