CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 58 enrolled
Drug / intervention
D-Cycloserine +2 moredrug
Likely dose
D-Cycloserine 50 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01981759
NCT01981759Phase 4Completed
CompareCT.gov

D-Cycloserine Augmentation of Cognitive Behavioral Therapy for Delusions

NYU Langone Health·interventional·Posted Nov 13, 2013·Updated Mar 25, 2020

In Brief

A Phase 4 clinical trial evaluating D-Cycloserine, Placebo, and 1 other intervention for Schizophrenia and 2 related conditions. Completed, enrolled 58 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSchizophrenia, Schizoaffective Disorder, Delusional Disorder
CountriesUnited States
CollaboratorsNational Institute of Mental Health (NIMH)

Timeline

Phase 4CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedNov 13, 2013
Enrollment StartFeb 1, 2014
Primary CompletionMay 1, 2017
Study CompletionOct 1, 2017
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 12.6 years ago

Interventions

D-Cycloserinedrug

Participants will receive 10 administrations of 50 mg of D-Cycloserine by mouth one hour before CBT sessions, weekly, in weeks 3-12.

Placeboother

Participants will receive 12 weekly administrations of placebo by mouth 1 hour before CBT sessions, from weeks 1-12.

Cognitive Behavioral Therapybehavioral

Participants will engage in a Cognitive Behavioral Therapy treatment plan designed for psychotic delusions. The program will consist of 12 one hour sessions, once weekly from study week 1-week 12.