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NCT01981759 · ClinicalTrials.gov registry record · Phase 4
D-Cycloserine Augmentation of Cognitive Behavioral Therapy for Delusions
A Phase 4 study, sponsored by NYU Langone Health.
- Completed
- Registry status
- Phase 4
- Development phase
- 58
- Enrollment target
NCT01981759: Completed Phase 4 study, sponsored by NYU Langone Health.
NCT01981759 is a Phase 4 study that has completed, run by NYU Langone Health. The registered enrollment target is 58 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (89% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01981759, a Phase 4 study, has completed, sponsored by NYU Langone Health.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 58 participants
- Enrollment target
Study 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.
Primary Outcome
The change in the Delusions subscale total of the Psychotic Symptoms Rating Scale (PSYRATS) from Baseline to Week 12. The Delusions subscale is a composite score of 6 items each rated from 0-4 with 4 indicating more severe symptomology. The Delusions subscale has a possible range of 0-24.
Interventions
- OTHER Placebo
- BEHAVIORAL Cognitive Behavioral Therapy
- DRUG D-Cycloserine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 58 participants |
| Start Date | 2014-02 |
| Est. Completion | 2017-10 |
| Phase | Phase 4 |
What the finished NCT01981759 record still lists
NCT01981759 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 58 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (89% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01981759 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01981759 about?
NCT01981759 is a clinical study titled "D-Cycloserine Augmentation of Cognitive Behavioral Therapy for Delusions". 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...
What is the current status of trial NCT01981759?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 58 participants. The study started on 2014-02. Estimated completion is 2017-10.
What interventions are being tested in trial NCT01981759?
The interventions under investigation include: Placebo (OTHER), Cognitive Behavioral Therapy (BEHAVIORAL), D-Cycloserine (DRUG).
Who is sponsoring clinical trial NCT01981759?
This trial is sponsored by NYU Langone Health, which has 1,164 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01981759's enrollment target sits among peer trials
58 1205th of 2000 higher than 792 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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