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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 is a Phase 4 study that was terminated before completion, run by Emory University. The registered enrollment target is 32 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00746421
The ClinicalTrials.gov registry entry for NCT00746421 describes a study currently listed as terminated, categorized as Phase 4. The registered enrollment target is 32 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Emory University, which has 1,208 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00746421 reports 0 study locations.
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.
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