OBJECTIVES: Primary Objective: To assess the objective (polysomnographic) changes in sleep quality before and after introduction of olanzapine in treatment of patients with depression. Secondary Objectives: 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. STUDY DESIGN: 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
27
Olanzapine will be taken once daily at 6pm for 1 month. Dosing will be titrated up to 5mg and then changed as clinically indicated.
An inactive form of the treatment will be taken once daily at 6pm for 1 month.
Queen's University, Providence Care-Mental Health Services
Kingston, Ontario, Canada
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
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