Clinical Trial: D-Cycloserine Augmentation of Cognitive Behavioral Therapy for Delusions

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: D-Cycloserine Augmentation of Cognitive Behavioral Therapy for Delusions

Brief 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.

Detailed Summary:

This study consists of 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. This study will be conducted by the Schizophrenia Research Group of the NYU Langone Medical Center at One Park Avenue 8th Floor and the Psychiatry Outpatient Clinic of Bellevue Hospital located in New York, NY.

Upon signing consent, patients will undergo screening procedures to assess eligibility. A diagnosis of schizophrenia, schizoaffective disorder, or delusional disorder will be determined by the Structured Clinical Interview for DSM IV (SCID) completed by a research clinician using all available clinical data and will be confirmed by consensus diagnosis. A comprehensive medical history and physical exam, including measurement of vital signs, will be performed. A psychiatric history, including diagnosis, treatment history, current medications, and substance use will also be performed. A research assistant will complete the demographics and administer the Scale for Assessment of Positive Symptoms-Delusions (SAPS-D).

At screening only, a fasting blood sample will be obtained to perform routine laboratory tests including electrolytes, BUN, creatinine, liver function tests, fasting glucose, calcium, phosphate, magnesium, albumin and CBC with differential. Urinalysis will be performed to identify unstable medical illness. A urine toxicology screen will be performed and a urine pregnancy test will be done for women of child bearing potential.

The change in the Delusions section of the Psychotic Symptoms Rating Scale (PSYRATS)from Baseline to Week 12.



Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Change in Logical Memory Test-WMS-III [ Time Frame: Screening Visit 2, Baseline, Week 3, ]
    The change in the WMS-III from screening visit 2 to baseline, as a predictor of later change in PSYRATS-D scores from baseline to week 12.
  • Change in Alternate Beliefs Exercise (ABE) [ Time Frame: Week 3, Week 4, Week 12 ]
    The change in number of alternate beliefs generated from weeks 3 to 4 as a predictor of improvement of the PSYRATS Delusions Subscale total score at 12 weeks.


Original Secondary Outcome: Same as current

Information By: New York University School of Medicine

Dates:
Date Received: October 29, 2013
Date Started: February 2014
Date Completion: October 2017
Last Updated: March 8, 2017
Last Verified: March 2017