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NCT01934972 · ClinicalTrials.gov registry record · Phase 3
A Randomized Controlled Trial of Cognitive Remediation and D-cycloserine for Individuals With Bipolar Disorder
A Phase 3 study, sponsored by University of Arizona.
- Completed
- Registry status
- Phase 3
- Development phase
- 30
- Enrollment target
NCT01934972: Completed Phase 3 study, sponsored by University of Arizona.
NCT01934972 is a Phase 3 study that has completed, run by University of Arizona. The registered enrollment target is 30 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01934972, a Phase 3 study, has completed, sponsored by University of Arizona.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 30 participants
- Enrollment target
Study Summary
Individuals with bipolar suffer from problems in basic cognitive skills such as memory and concentration. Unfortunately, there are no current treatments that have been shown to improve cognitive skills among individuals with bipolar disorder. Computerized cognitive remediation (CR) is a treatment that has been shown to improve cognitive skills among individuals with serious mental illnesses other than bipolar disorder, such as schizophrenia. This treatment involves completing a series of activities on a computer that have been shown to improve cognitive skills. D-cycloserine (DCS) is an antibiotic traditionally used in the treatment of tuberculosis. Recent studies have suggested that this drug may also improve individuals' ability to learn. Thus, the goal of our study is to examine whether receipt of d-cycloserine increases the benefit that individuals receive from participation in cognitive remediation. To test this hypothesis, approximately forty subjects will be randomized to one of two study arms: \[i\] CR + DCS or \[ii\] CR + placebo. We will examine whether d-cycloserine increases the benefit that individuals with bipolar disorder receive from participation in cognitive remediation.
Primary Outcome
Level of cognitive functioning will be assessed via overall cognitive composite score from the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery. Scores on the MATRICS are presented at T-scores with a mean of 50 and standard deviation of 10 as compared to a normative sample. The possible range of scores are 0-100. Higher scores are indicative of better cognitive functioning. Change from baseline in cognitive functioning was calculated
Interventions
- OTHER CR + DCS (D-cycloserine)
- OTHER CR + placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2013-03 |
| Est. Completion | 2017-04 |
| Phase | Phase 3 |
What the finished NCT01934972 record still lists
NCT01934972 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 2 interventions - of which CR + DCS (D-cycloserine) is the first listed.
NCT01934972 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01934972 about?
NCT01934972 is a clinical study titled "A Randomized Controlled Trial of Cognitive Remediation and D-cycloserine for Individuals With Bipolar Disorder". Individuals with bipolar suffer from problems in basic cognitive skills such as memory and concentration. Unfortunately, there are no current treatments that have been shown to improve cognitive skills among individuals with bipolar disorder. Computerized cognitive remediation (CR) is a treatment t...
What is the current status of trial NCT01934972?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 30 participants. The study started on 2013-03. Estimated completion is 2017-04.
What interventions are being tested in trial NCT01934972?
The interventions under investigation include: CR + DCS (D-cycloserine) (OTHER), CR + placebo (OTHER).
Who is sponsoring clinical trial NCT01934972?
This trial is sponsored by University of Arizona, which has 349 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01934972's enrollment target sits among peer trials
30 1917th of 2000 higher than 68 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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