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

This study has been completed.
Sponsor:
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

August 22, 2007
June 8, 2009
October 2007
May 2009   (final data collection date for primary outcome measure)
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 ]
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 ]
Complete list of historical versions of study NCT00520507 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 ]
  • 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 ]
  • Subjective sleep experience: visual analogue scale, sleep diary, Epworth Sleep Scale and Pittsburgh Sleep Quality Index. Cognition: CANTAB scores. Illness severity: HDRS-17, MADRS, CGI and HamA. [ Time Frame: Baseline, 3 days and 1 month after baseline ]
  • Changes in weight and blood glucose will be monitored. [ Time Frame: At baseline and 1 month ]
Not Provided
Not Provided
 
An Investigation of the Sleep Architecture and Consequent Cognitive Changes in Olanzapine-Treated Depressed Patients
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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Bipolar Disorder
  • Depression
  • Depressive Disorder
  • 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.
  • Drug: Placebo
    An inactive form of the treatment will be taken once daily at 6pm for 1 month.
  • Experimental: 1
    Intervention: Drug: Olanzapine
  • Placebo Comparator: 2
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
27
May 2009
May 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00520507
PSIY-263-07
No
Dr. R. Milev, Queen's University
Queen's University
Eli Lilly and Company
Principal Investigator: Roumen Milev, M.D. Queen's University, Department of Psychiatry
Queen's University
June 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP