An Investigation of the Sleep Architecture and Consequent Cognitive Changes in Olanzapine-Treated Depressed Patients
To assess the objective (polysomnographic) changes in sleep quality before and after introduction of olanzapine in treatment of patients with depression.
To assess the subjective changes in sleep quality parameters before and at different stages after introduction of olanzapine in treatment, longitudinally, and to correlate these changes with measures of illness severity and changes in cognition.
Prospective, double blind, randomized polysomnographic (PSG) study of patients before and after treatment with olanzapine.
PSG recordings will be done three times throughout the study: before starting olanzapine augmentation (baseline), at day 3 to 5 (acute) and day 28 to 31 (chronic). PSG will be completed at patients' homes with a portable PSG. Psychiatric scales, subjective sleep quality scales, and cognition measurements will be completed at each visit.
|Bipolar Disorder Depression Depressive Disorder||Drug: Olanzapine Drug: Placebo||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||An Investigation of the Sleep Architecture and Consequent Cognitive Changes in Olanzapine-Treated Depressed Patients|
- Sleep quality as measured by overnight PSG, defined as the change in time spent in slow wave sleep. [ Time Frame: 3 days after baseline and 1 month after baseline ]
- Sleep measures: time in bed, total sleep time, sleep period time, percentage of sleep stages (stage 1, stage 2, slow wave sleep, REM sleep) of sleep period time, sleep latency to stage 1 and 2, REM latency, number of awakenings. [ Time Frame: measure taken at baseline, 3 days after baseline, and 1 month after baseline ]
- Respiratory events (during PSG): obstructive sleep apneas, mixed apneas, central apneas, total apneas, obstructive hypopneas, mixed hypopneas, central hypopneas, total hypopneas, and apneas + hypopneas (AHI), oxygen saturation, and heart rate. [ Time Frame: Baseline, 3 days and 1 month after baseline ]
- Subjective sleep experience: visual analogue scale, sleep diary, Epworth Sleep Scale and Pittsburgh Sleep Quality Index. [ Time Frame: Baseline, 3 days and 1 month after baseline ]
- Changes in weight and blood glucose will be monitored. [ Time Frame: At baseline and 1 month ]
- Cognition: CANTAB scores [ Time Frame: Baseline, 3 days and 1 month after baseline ]
- Illness severity: HDRS-17, MADRS, CGI and HamA [ Time Frame: Baseline, 3 days and 1 month after baseline ]
|Study Start Date:||October 2007|
|Study Completion Date:||May 2009|
|Primary Completion Date:||May 2009 (Final data collection date for primary outcome measure)|
Olanzapine will be taken once daily at 6pm for 1 month. Dosing will be titrated up to 5mg and then changed as clinically indicated.
|Placebo Comparator: 2||
An inactive form of the treatment will be taken once daily at 6pm for 1 month.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00520507
|Queen's University, Providence Care-Mental Health Services|
|Kingston, Ontario, Canada, K7L 4X3|
|Principal Investigator:||Roumen Milev, M.D.||Queen's University, Department of Psychiatry|