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

NCT ID: NCT00520507

Last Updated: 2015-12-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-10-31
• Study Completion Date: 2009-05-31

Brief 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

Keywords

Depression; Bipolar Disorder; Major

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

1

Group Type: EXPERIMENTAL

Olanzapine

Intervention Type: DRUG

Olanzapine will be taken once daily at 6pm for 1 month. Dosing will be titrated up to 5mg and then changed as clinically indicated.

2

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

Interventions

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.

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eli Lilly and Company

INDUSTRY

Sponsor Role: collaborator

Queen's University

OTHER

Sponsor Role: lead

Responsible Party

Dr. Roumen Milev

Prinicpal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Roumen Milev, M.D.

Role: PRINCIPAL_INVESTIGATOR

Queen's University, Department of Psychiatry

Locations

Queen's University, Providence Care-Mental Health Services

Kingston, Ontario, Canada

Countries

Canada

References

Lazowski LK, Townsend B, Hawken ER, Jokic R, du Toit R, Milev R. Sleep architecture and cognitive changes in olanzapine-treated patients with depression: a double blind randomized placebo controlled trial. BMC Psychiatry. 2014 Jul 17;14:202. doi: 10.1186/1471-244X-14-202.

Reference Type: DERIVED

PMID: 25030264 (View on PubMed)

Other Identifiers

PSIY-263-07

Identifier Type: -

Identifier Source: org_study_id