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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00520507
Recruitment Status : Completed
First Posted : August 24, 2007
Last Update Posted : December 16, 2015
Eli Lilly and Company
Information provided by (Responsible Party):
Dr. Roumen Milev, Queen's University

Brief Summary:


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.


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.

Condition or disease Intervention/treatment Phase
Bipolar Disorder Depression Depressive Disorder Drug: Olanzapine Drug: Placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: An Investigation of the Sleep Architecture and Consequent Cognitive Changes in Olanzapine-Treated Depressed Patients
Study Start Date : October 2007
Actual Primary Completion Date : May 2009
Actual Study Completion Date : May 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1 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 Comparator: 2 Drug: Placebo
An inactive form of the treatment will be taken once daily at 6pm for 1 month.

Primary Outcome Measures :
  1. 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 Measures :
  1. 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. [ Time Frame: measure taken at baseline, 3 days after baseline, and 1 month after baseline ]
  2. 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. [ Time Frame: Baseline, 3 days and 1 month after baseline ]
  3. 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 ]
  4. Changes in weight and blood glucose will be monitored. [ Time Frame: At baseline and 1 month ]
  5. Cognition: CANTAB scores [ Time Frame: Baseline, 3 days and 1 month after baseline ]
  6. Illness severity: HDRS-17, MADRS, CGI and HamA [ Time Frame: Baseline, 3 days and 1 month after baseline ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00520507

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Canada, Ontario
Queen's University, Providence Care-Mental Health Services
Kingston, Ontario, Canada, K7L 4X3
Sponsors and Collaborators
Queen's University
Eli Lilly and Company
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Principal Investigator: Roumen Milev, M.D. Queen's University, Department of Psychiatry

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Dr. Roumen Milev, Prinicpal Investigator, Queen's University Identifier: NCT00520507     History of Changes
Other Study ID Numbers: PSIY-263-07
First Posted: August 24, 2007    Key Record Dates
Last Update Posted: December 16, 2015
Last Verified: December 2015
Keywords provided by Dr. Roumen Milev, Queen's University:
Bipolar Disorder
Additional relevant MeSH terms:
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Depressive Disorder
Bipolar Disorder
Pathologic Processes
Behavioral Symptoms
Mood Disorders
Mental Disorders
Bipolar and Related Disorders
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents