An Investigation of the Sleep Architecture and Consequent Cognitive Changes in Olanzapine-Treated Depressed Patients
This study has been completed.
Sponsor:
Queen's University
Collaborator:
Eli Lilly and Company
Information provided by:
Queen's University
ClinicalTrials.gov Identifier:
NCT00520507
First received: August 22, 2007
Last updated: June 8, 2009
Last verified: June 2009
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Bipolar Disorder Depression Depressive Disorder |
Drug: Olanzapine Drug: Placebo |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | An Investigation of the Sleep Architecture and Consequent Cognitive Changes in Olanzapine-Treated Depressed Patients |
Resource links provided by NLM:
Further study details as provided by Queen's University:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
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. [ Time Frame: measure taken at baseline, 3 days after baseline, and 1 month after baseline ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- Changes in weight and blood glucose will be monitored. [ Time Frame: At baseline and 1 month ] [ Designated as safety issue: Yes ]
- Cognition: CANTAB scores [ Time Frame: Baseline, 3 days and 1 month after baseline ] [ Designated as safety issue: No ]
- Illness severity: HDRS-17, MADRS, CGI and HamA [ Time Frame: Baseline, 3 days and 1 month after baseline ] [ Designated as safety issue: No ]
| Enrollment: | 27 |
| Study Start Date: | October 2007 |
| Study Completion Date: | May 2009 |
| Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00520507
Locations
| 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
Investigators
| Principal Investigator: | Roumen Milev, M.D. | Queen's University, Department of Psychiatry |
More Information
No publications provided
| Responsible Party: | Dr. R. Milev, Queen's University |
| ClinicalTrials.gov Identifier: | NCT00520507 History of Changes |
| Other Study ID Numbers: | PSIY-263-07 |
| Study First Received: | August 22, 2007 |
| Last Updated: | June 8, 2009 |
| Health Authority: | Canada: Health Canada |
Keywords provided by Queen's University:
|
Depression Bipolar Disorder Major |
Additional relevant MeSH terms:
|
Bipolar Disorder Depression Depressive Disorder Affective Disorders, Psychotic Mood Disorders Mental Disorders Behavioral Symptoms Olanzapine Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions |
Central Nervous System Agents Therapeutic Uses Psychotropic Drugs Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Serotonin Agents Antiemetics Autonomic Agents Peripheral Nervous System Agents Gastrointestinal Agents |
ClinicalTrials.gov processed this record on May 19, 2013