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

Primary Purpose

Bipolar Disorder, Depression, Depressive Disorder

Status

Completed

Phase

Phase 4

Locations

Canada

Study Type

Interventional

Intervention

Olanzapine

Placebo

About this trial

This is an interventional treatment trial for Bipolar Disorder focused on measuring Depression, Bipolar Disorder, Major

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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)
Current depressive episode with a HAMD-17 of > 15
Males or females over age18 years (yrs)
Inpatients or outpatients
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
Able to understand and comply with the requirements of the study
Provision of written informed consent

Exclusion Criteria:

Current manic, hypomanic or mixed episode, with YMRS > 12
Current or past diagnosis of schizophrenia and dementia
Pregnant women, or women in childbearing age, not willing to use appropriate contraception or women currently nursing
Patient on any other antipsychotic medication
Patients who, in the opinion of the investigator, pose an imminent risk of suicide or a danger to self or others
Known intolerance or lack of response to olanzapine, as judged by the investigator
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
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
Administration of a depot antipsychotic injection within two dosing interval (for the depot) before randomization
Substance or alcohol dependence at enrolment or in the last three months (except for caffeine or nicotine dependence), as defined by DSM-IV criteria
Serious, unstable or inadequately treated medical illness as judged by the investigator
History of epilepsy or uncontrolled seizures
Involvement in the planning and conduct of the study
Previous enrolment in the present study
Participation in another drug trial within 4 weeks prior enrolment into this study or longer in accordance with local requirements

Sites / Locations

Queen's University, Providence Care-Mental Health Services

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm Description

Outcomes

Primary Outcome Measures

Sleep quality as measured by overnight PSG, defined as the change in time spent in slow wave sleep.

Secondary Outcome Measures

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.

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.

Subjective sleep experience: visual analogue scale, sleep diary, Epworth Sleep Scale and Pittsburgh Sleep Quality Index.

Changes in weight and blood glucose will be monitored.

Cognition: CANTAB scores

Illness severity: HDRS-17, MADRS, CGI and HamA

Full Information

NCT ID

NCT00520507

First Posted

August 22, 2007

Last Updated

December 14, 2015

Sponsor

Queen's University

Collaborators

Eli Lilly and Company

1. Study Identification

Unique Protocol Identification Number

NCT00520507

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2015

Overall Recruitment Status

Completed

Study Start Date

October 2007 (undefined)

Primary Completion Date

May 2009 (Actual)

Study Completion Date

May 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Queen's University

Collaborators

Eli Lilly and Company

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Bipolar Disorder, Depression, Depressive Disorder

Keywords

Depression, Bipolar Disorder, Major

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

27 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Title

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Olanzapine

Intervention Description

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

Intervention Name(s)

Placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

Time Frame

measure taken at baseline, 3 days after baseline, and 1 month after baseline

Title

Time Frame

Baseline, 3 days and 1 month after baseline

Title

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

Title

Changes in weight and blood glucose will be monitored.

Time Frame

At baseline and 1 month

Title

Cognition: CANTAB scores

Time Frame

Baseline, 3 days and 1 month after baseline

Title

Illness severity: HDRS-17, MADRS, CGI and HamA

Time Frame

Baseline, 3 days and 1 month after baseline

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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) Current depressive episode with a HAMD-17 of > 15 Males or females over age18 years (yrs) Inpatients or outpatients 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 Able to understand and comply with the requirements of the study Provision of written informed consent Exclusion Criteria: Current manic, hypomanic or mixed episode, with YMRS > 12 Current or past diagnosis of schizophrenia and dementia Pregnant women, or women in childbearing age, not willing to use appropriate contraception or women currently nursing Patient on any other antipsychotic medication Patients who, in the opinion of the investigator, pose an imminent risk of suicide or a danger to self or others Known intolerance or lack of response to olanzapine, as judged by the investigator 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 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 Administration of a depot antipsychotic injection within two dosing interval (for the depot) before randomization Substance or alcohol dependence at enrolment or in the last three months (except for caffeine or nicotine dependence), as defined by DSM-IV criteria Serious, unstable or inadequately treated medical illness as judged by the investigator History of epilepsy or uncontrolled seizures Involvement in the planning and conduct of the study Previous enrolment in the present study Participation in another drug trial within 4 weeks prior enrolment into this study or longer in accordance with local requirements

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Roumen Milev, M.D.

Organizational Affiliation

Queen's University, Department of Psychiatry

Official's Role

Principal Investigator

Facility Information:

Facility Name

Queen's University, Providence Care-Mental Health Services

City

Kingston

State/Province

Ontario

ZIP/Postal Code

K7L 4X3

Country

Canada

12. IPD Sharing Statement

Citations:

PubMed Identifier

25030264

Citation

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.

Results Reference

derived

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

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