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NCT00746421 · ClinicalTrials.gov registry record · Phase 4
Quetiapine XR for Cognitive and Functional Disability in Clinically Stable Patients With Bipolar Disorder
A Phase 4 study, sponsored by Emory University.
- Terminated
- Registry status
- Phase 4
- Development phase
- 32
- Enrollment target
NCT00746421: Clinical Trial Phase 4 study, sponsored by Emory University.
NCT00746421 is a Phase 4 study that was terminated before completion, run by Emory University. The registered enrollment target is 32 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00746421, a Phase 4 study, was terminated before completion, sponsored by Emory University.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 32 participants
- Enrollment target
Study Summary
Quetiapine has been reported to have beneficial cognitive effects in several randomized controlled trials in schizophrenia. It has not yet been studied in bipolar disorder, but promising results from the use of extended release quetiapine for the maintenance treatment of bipolar disorder suggests that its cognitive benefits could be detected. Moreover, quetiapine has been shown to have direct beneficial effects on performance-based measures of social competence in schizophrenia and to improve quality of life (QoL) in bipolar depression. The investigators propose to study quetiapine augmentation of mood stabilizer monotherapy in clinically stable patients with bipolar disorder. This will be a randomized, placebo controlled trial, with attentional impairments as the primary outcome and other cognitive performance variables and measures of social and everyday living skills, as well as subjective QoL, as the secondary outcomes.
Primary Outcome
The Continuous Performance Test, Identical Pairs version (CPT-IP) is a cognitive test that requires a subject to respond whenever two identical stimuli appear in a row within a sequence of 150 rapidly flashed trials. The outcome is measured as d' (detection signal) and is dimensionless. Among healthy adult men and women, d' scores ranged from 3.07-4.57 (Chen et al. Schizophrenia Bulletin, 1998; 24(1):163-174). The higher the value the better the performance. The d' is calculated by averaging the
Interventions
- DRUG Placebo
- DRUG Quetiapine XR
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2010-01 |
| Est. Completion | 2012-04 |
| Phase | Phase 4 |
Why NCT00746421 stopped before completion
NCT00746421 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00746421 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00746421 about?
NCT00746421 is a clinical study titled "Quetiapine XR for Cognitive and Functional Disability in Clinically Stable Patients With Bipolar Disorder". Quetiapine has been reported to have beneficial cognitive effects in several randomized controlled trials in schizophrenia. It has not yet been studied in bipolar disorder, but promising results from the use of extended release quetiapine for the maintenance treatment of bipolar disorder suggests th...
What is the current status of trial NCT00746421?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 32 participants. The study started on 2010-01. Estimated completion is 2012-04.
What interventions are being tested in trial NCT00746421?
The interventions under investigation include: Placebo (DRUG), Quetiapine XR (DRUG).
Who is sponsoring clinical trial NCT00746421?
This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00746421's enrollment target sits among peer trials
32 1534th of 2000 higher than 457 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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