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

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00520507
• Other study ID #: PSIY-263-07
• Status: Completed
• Phase: Phase 4
• First received: August 22, 2007
• Last updated: December 14, 2015
• Start date: October 2007
• Est. completion date: May 2009

Study information

• Verified date: December 2015
• Source: Queen's University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: May 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. A diagnosis of major depressive disorder or bipolar disorder type 1, 2 or NOS by Diagnostic and Statistical Manual of Mental Disorders- Fourth Edition (DSM-IV)

2. Current depressive episode with a HAMD-17 of > 15

3. Males or females over age18 years (yrs)

4. Inpatients or outpatients

5. Female patients of childbearing potential must be using a reliable method of contraception and have a negative urine human chorionic gonadotropin (HCG) test at enrollment

6. Able to understand and comply with the requirements of the study

7. Provision of written informed consent

Exclusion Criteria:

1. Current manic, hypomanic or mixed episode, with YMRS > 12

2. Current or past diagnosis of schizophrenia and dementia

3. Pregnant women, or women in childbearing age, not willing to use appropriate contraception or women currently nursing

4. Patient on any other antipsychotic medication

5. Patients who, in the opinion of the investigator, pose an imminent risk of suicide or a danger to self or others

6. Known intolerance or lack of response to olanzapine, as judged by the investigator

7. Benzodiazepines and all other sleep-aids must be discontinued prior to participation in the study if they have not been at a stable dosage for the 4 weeks previous to entry into the study

8. No change to the current medication regime (excluding discontinuation of sleep aids and antipsychotic medications) is allowed 4 weeks prior to the first PSG reading

9. Administration of a depot antipsychotic injection within two dosing interval (for the depot) before randomization

10. Substance or alcohol dependence at enrolment or in the last three months (except for caffeine or nicotine dependence), as defined by DSM-IV criteria

11. Serious, unstable or inadequately treated medical illness as judged by the investigator

12. History of epilepsy or uncontrolled seizures

13. Involvement in the planning and conduct of the study

14. Previous enrolment in the present study

15. Participation in another drug trial within 4 weeks prior enrolment into this study or longer in accordance with local requirements

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bipolar Disorder
• Depression
• Depressive Disorder
• Disease

Intervention

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.
• Placebo
An inactive form of the treatment will be taken once daily at 6pm for 1 month.

Locations

Country	Name	City	State
Canada	Queen's University, Providence Care-Mental Health Services	Kingston	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Queen's University	Eli Lilly and Company

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sleep quality as measured by overnight PSG, defined as the change in time spent in slow wave sleep.		3 days after baseline and 1 month after baseline	No
Secondary	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.		measure taken at baseline, 3 days after baseline, and 1 month after baseline	No
Secondary	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.		Baseline, 3 days and 1 month after baseline	No
Secondary	Subjective sleep experience: visual analogue scale, sleep diary, Epworth Sleep Scale and Pittsburgh Sleep Quality Index.		Baseline, 3 days and 1 month after baseline	No
Secondary	Changes in weight and blood glucose will be monitored.		At baseline and 1 month	Yes
Secondary	Cognition: CANTAB scores		Baseline, 3 days and 1 month after baseline	No
Secondary	Illness severity: HDRS-17, MADRS, CGI and HamA		Baseline, 3 days and 1 month after baseline	No