An Investigation of the Sleep Architecture and Consequent Cognitive Changes in Olanzapine-Treated Depressed Patients
Status:
Completed
Trial end date:
2009-05-01
Target enrollment:
Participant gender:
Summary
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.