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Trial record 33 of 69 for:    "Bipolar Disorder" | "Olanzapine"

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

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ClinicalTrials.gov Identifier: NCT00520507
Recruitment Status : Completed
First Posted : August 24, 2007
Last Update Posted : December 16, 2015
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Dr. Roumen Milev, Queen's University

Tracking Information
First Submitted Date  ICMJE August 22, 2007
First Posted Date  ICMJE August 24, 2007
Last Update Posted Date December 16, 2015
Study Start Date  ICMJE October 2007
Actual Primary Completion Date May 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 22, 2007)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00520507 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 5, 2008)
  • 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. [ 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 ]
  • Cognition: CANTAB scores [ Time Frame: Baseline, 3 days and 1 month after baseline ]
  • Illness severity: HDRS-17, MADRS, CGI and HamA [ Time Frame: Baseline, 3 days and 1 month after baseline ]
Original Secondary Outcome Measures  ICMJE
 (submitted: August 22, 2007)
  • 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE An Investigation of the Sleep Architecture and Consequent Cognitive Changes in Olanzapine-Treated Depressed Patients
Official Title  ICMJE An Investigation of the Sleep Architecture and Consequent Cognitive Changes in Olanzapine-Treated Depressed Patients
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Bipolar Disorder
  • Depression
  • Depressive Disorder
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • Experimental: 1
    Intervention: Drug: Olanzapine
  • Placebo Comparator: 2
    Intervention: Drug: Placebo
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 8, 2009)
27
Original Estimated Enrollment  ICMJE
 (submitted: August 22, 2007)
40
Actual Study Completion Date  ICMJE May 2009
Actual Primary Completion Date May 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00520507
Other Study ID Numbers  ICMJE PSIY-263-07
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr. Roumen Milev, Queen's University
Study Sponsor  ICMJE Queen's University
Collaborators  ICMJE Eli Lilly and Company
Investigators  ICMJE
Principal Investigator: Roumen Milev, M.D. Queen's University, Department of Psychiatry
PRS Account Queen's University
Verification Date December 2015

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