An Investigation of Sleep Architecture in Ziprasidone-Treated Bipolar Depression
NCT00835107
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
- 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.
- 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.
NEED INFO?
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

TRY A NEW SEARCH
Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.
Based on your search, you may also be interested in
- Kingston, Ontario
- Singapore,
- New Haven, Connecticut
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 |
| ||||||
Study Arms ICMJE |
| ||||||
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 | 14 | ||||||
Original Estimated Enrollment ICMJE | 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:
Exclusion Criteria:
| ||||||
Sex/Gender ICMJE |
| ||||||
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 |
| ||||||
Investigators ICMJE |
| ||||||
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 |