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Completed

NCT Number: NCT00520507

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

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.

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Key information

Conditions

Bipolar Disorder Behavior Behavioral Symptoms Bipolar and Related Disorders Depression Depressive Disorder Mental Disorders Mood Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Queen's University, Providence Care-Mental Health Services

Kingston, Ontario, K7L 4X3, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Olanzapine

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.

Placebo

Drug

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Queen's University

Other

Collaborators

  • Eli Lilly and Company

Registry information

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Aug 24, 2007
Registry last updated
Dec 16, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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