Effect of Quetiapine on Sleep Architecture in Bipolar Depression and Major Depressive Disorder
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Effects of Seroquel on Sleep Architecture in Patients With Bipolar Depression or Major Depressive Disorder - An Open Label Study|
- Sleep quality as measured by overnight PSG. [ Time Frame: baseline, day 2 to 4 (early) and day 21 to 28 (longer term). Optional reading at day 42-56 ] [ Designated as safety issue: No ]
|Study Start Date:||May 2006|
|Study Completion Date:||January 2009|
|Primary Completion Date:||January 2009 (Final data collection date for primary outcome measure)|
Seroquel added to medication regime and sleep quality measured
The dosage is flexible from 50-600 mg based on the investigator's clinical judgement and patient tolerance. It may be raised or lowered at will.
Other Name: Quetiapine
To assess the objective (polysomnographic) change in sleep quality before and after introduction of Seroquel (Quetiapine) in treatment of patients with Bipolar Depression or Major Depressive Disorder.
To assess the objective (polysomnographic) and subjective changes in sleep quality parameters before and at different stages after introduction of Seroquel (Quetiapine) treatment, longitudinally, and to correlate these changes with measures of illness severity.
Prospective polysomnographic (PSG) study of patients before and after treatment with Seroquel (Quetiapine). PSG recordings will be done three (optional four) times during the study: before starting the Seroquel (Quetiapine) (baseline), at day 2 to 4 (early) and day 21 to 28 (longer term). (Optional fourth PSG can be done at day 42-56). PSG will be completed at patients home with a portable PSG.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00616889
|Kingston, Ontario, Canada, K7L 4X3|
|Principal Investigator:||Roumen V Milev, MD||Queen's University|