Phase 4
Completed N=58
D-Cycloserine Augmentation of Cognitive Behavioral Therapy for Delusions
Schizophrenia · schizoaffective disorder · Delusional Disorder
Source: ClinicalTrials.gov NCT01981759 ↗
Enrolled (actual)
58
Serious AEs
5.2%
Results posted
Jul 2018
Primary outcomePrimary: Change in Psychotic Symptoms Rating Scale-Delusions (PSYRATS-D) — 14.26; 11.83; 12.18; 11.91 units on a scale
Summary
This study is a placebo-controlled 12 week trial of DCS augmentation of once-weekly CBT sessions in 60 schizophrenia subjects with antipsychotic-resistant delusions. In addition to testing efficacy, this trial will characterize DCS effects in terms of time course and persistence of response and will examine DCS effects on memory consolidation and cognitive flexibility as possible mediators of DCS enhancement of CBT for delusions.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Psychotic Symptoms Rating Scale-Delusions (PSYRATS-D) |
14.26; 11.83; 12.18; 11.91 | — |
| SECONDARY Change in Logical Memory Test-WMS-III |
-0.96; -1.03 | — |
| SECONDARY Change in Alternate Beliefs Exercise (ABE) |
1.15; 0.59 | — |
Eligibility Criteria
Inclusion Criteria
- Age 18-68
- Diagnosis of schizophrenia, schizoaffective disorder, or delusional disorder
- Treated with any antipsychotic except clozapine for at least 8 weeks or antipsychotic naive for lifetime
- Willing to participate in CBT
- Sufficient proficiency in English to complete assessments
- Score of at least 3 on the SAPS at two assessments, four weeks apart
Exclusion Criteria
- Current treatment with clozapine
- SSRI treatment
- Active alcohol or other substance abuse within six weeks
- Unstable medical illness
- Pregnant or nursing
- Anemia
- Renal insufficiency
Data sourced from ClinicalTrials.gov (NCT01981759). 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.