Phase 4
Completed N=21
Using D-cycloserine to Enhance the Benefits of Cognitive Behavioral Therapy for Schizophrenia
Source: ClinicalTrials.gov NCT00742079 ↗Enrolled (actual)
21
Serious AEs
0.0%
Results posted
Sep 2014
Primary outcomePrimary: Change in Alternative Beliefs Assessment — 14.05; 10.70 units on a scale
Summary
This study will examine whether pretreatment with D-cycloserine before cognitive behavioral therapy can reduce impairments still present in people with stable cases of schizophrenia as well as determine which traits make schizophrenics most likely to respond to D-cycloserine treatment.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Alternative Beliefs Assessment |
14.05; 10.70 | — |
| SECONDARY Change in Psychotic Rating Scales (PSYRATS) Delusion Score |
-0.89; -0.47 | — |
| SECONDARY Change in Beck Cognitive Insight Scale (BCIS) |
-0.26; 0.44; 0.11; -0.56; -0.16; -0.11 | — |
| SECONDARY Change in Bead Task Score Measuring Probabilistic Reasoning |
0.45; 0.10 | — |
| SECONDARY Change in the Maudsley Assessment of Delusions Scale |
0.05; -0.16 | — |
Eligibility Criteria
Inclusion Criteria
- Meets DSM-IV criteria for schizophrenia, schizoaffective disorder, or schizophrenia, paranoid subtype, based on chart review, Structured Clinical Interview for DSM-IV, and consultation with the patient's clinicians
- Medicated with an antipsychotic agent other than clozapine at a stable dose for at least 6 weeks
- Scores at least 3, or "moderate," on the Scale for the Assessment of Positive Symptoms global delusion rating
- Paranoid or referential delusional content
- Never engaged in formal CBT psychotherapy in the past
Exclusion Criteria
- Diagnosis of a comorbid Axis I disorder other than schizophrenia
- Active substance abuse or dependence within 6 months
- Significant suicidal ideation within 6 weeks
- Pregnant or nursing
- Unstable medical disorder
- impaired renal clearance (creatinine <60mg/dL/min)
- Suffering from dementia
- Suffering from seizure disorder
Data sourced from ClinicalTrials.gov (NCT00742079). 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.