NCT00520507

An Investigation of the Sleep Architecture and Consequent Cognitive Changes in Olanzapine-Treated Depressed Patients

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: Queen's University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Bipolar Disorder
• Depression
• Depressive Disorder

Interventions

Type	Name	Description
DRUG	Olanzapine	Olanzapine will be taken once daily at 6pm for 1 month. Dosing will be titrated up to 5mg and then changed as clinically indicated.
DRUG	Placebo	An inactive form of the treatment will be taken once daily at 6pm for 1 month.

Timeline

• Start date: 2007-10-01
• Primary completion: 2009-05-01
• Completion: 2009-05-01
• First posted: 2007-08-24
• Last updated: 2015-12-16

Locations

1 site across 1 country: Canada