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Trial record 1 of 1 for:    NCT00835107
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An Investigation of Sleep Architecture in Ziprasidone-Treated Bipolar Depression

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ClinicalTrials.gov Identifier: NCT00835107
Recruitment Status : Completed
First Posted : February 3, 2009
Last Update Posted : December 16, 2015
Sponsor:
Collaborators:
Providence Health & Services
Pfizer
MDS Pharma Services
Information provided by (Responsible Party):
Dr. Roumen Milev, Queen's University

Tracking Information
First Submitted Date  ICMJE February 2, 2009
First Posted Date  ICMJE February 3, 2009
Last Update Posted Date December 16, 2015
Study Start Date  ICMJE February 2009
Actual Primary Completion Date June 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 2, 2009)
To assess the objective (polysomnographic) changes in sleep quality before and after introduction of Ziprasidone in treatment of patients with bipolar depression. [ Time Frame: 1 month ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 2, 2009)
To assess the subjective changes in sleep quality parameters before and at different stages after introduction of ziprasidone in treatment, longitudinally, and to correlate these changes with measures of illness severity. [ Time Frame: 1 month ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE An Investigation of Sleep Architecture in Ziprasidone-Treated Bipolar Depression
Official Title  ICMJE An Investigation of Sleep Architecture in Ziprasidone-Treated Bipolar Depression
Brief Summary This study uses polysomnographs(PSG) to investigate sleep patterns in patients with bipolar depression. This is a double-blind, placebo-controlled, study of ziprasidone that is added to patients current medications. The objective is to relate changes in slow wave and rapid eye movement sleep to changes in mood and overall illness severity. Participants will be randomly assigned to add either placebo or ziprasidone to their current treatment regimen. Participants make 3 to 4 study visits, over a 1 month period, at which they will be asked about their history, mood and sleep quality. Participants will also have three in-home overnight polysomnographs.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Depression, Bipolar
Intervention  ICMJE
  • Drug: ziprasidone hydrochloride
    oral capsules, from 40-80 mg BID, for one month with the option to continue the medication after the study has been completed
    Other Name: Zeldox
  • Drug: placebo
    placebo comparator, oral capsules, BID, for one month
Study Arms  ICMJE
  • Experimental: Ziprasidone
    Intervention: Drug: ziprasidone hydrochloride
  • Placebo Comparator: Sugar pill
    Intervention: Drug: placebo
Publications *

*   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: November 21, 2011)
14
Original Estimated Enrollment  ICMJE
 (submitted: February 2, 2009)
32
Actual Study Completion Date  ICMJE June 2011
Actual Primary Completion Date June 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • A diagnosis of 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 >16.
  • Males or Females over age 18yrs.
  • 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 enrolment.
  • 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 Ziprasidone, 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.
  • Patients with serum potassium, magnesium and/or calcium levels outside the normal range at baseline.
  • Patients with marked liver function abnormalities at baseline, demonstrated by laboratory values, by judgment of the investigator.
  • Known serological evidence of HIV, or acute or chronic hepatitis; donation of blood or blood products for transfusion prior to initiation of the treatment with study drug, during the study and for 30 days after the study has ended.
  • Known history of QT prolongation (including congenital long QT syndrome).
  • Recent acute myocardial infarction or uncompensated heart failure.
  • Currently taking other drugs that are known to prolong the QT interval.
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 NCT00835107
Other Study ID Numbers  ICMJE PSIY-287-08
GA128250
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
  • Providence Health & Services
  • Pfizer
  • MDS Pharma Services
Investigators  ICMJE
Principal Investigator: Roumen Milev, MD Queen's University
Principal Investigator: Anusha Baskaran, BScH Queen's University
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