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Phase IV Study of Quetiapine XR Aimed at Disability and Cognitive Impairments.
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.
Details
| Lead sponsor | Emory University |
|---|---|
| Phase | Phase 4 |
| Status | TERMINATED |
| Enrolment | 32 |
| Start date | 2010-01 |
| Completion | 2012-04 |
Conditions
- Bipolar Disorder
- Cognitive Impairment
Interventions
- Quetiapine XR
- Placebo
Primary outcomes
- The Continuous Performance Test-Identical Pairs Version — 6 weeks
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 d' scores from three trials.
Countries
United States