CompletedPhase 4

D-Cycloserine Augmentation of Cognitive Behavioral Therapy for Delusions

United States58 participantsStarted 2014-02

Plain-language 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.

Who can participate

Age range18 Years – 68 Years

SexALL

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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

What they're measuring

Change in Psychotic Symptoms Rating Scale-Delusions (PSYRATS-D)

Timeframe: Baseline to Week 12

Trial details

NCT IDNCT01981759

SponsorNYU Langone Health

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-05

Results submitted2018-06-08

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