Status:
COMPLETED
An Investigation of Sleep Architecture in Ziprasidone-Treated Bipolar Depression
Lead Sponsor:
Queen's University
Collaborating Sponsors:
Providence Health & Services
Pfizer
Conditions:
Depression, Bipolar
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 curre...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2011
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT00835107
Start Date
February 1 2009
End Date
June 1 2011
Last Update
December 16 2015
Active Locations (1)
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1
Providence Care Mental Health Services
Kingston, Ontario, Canada, K7L 4X3