Status:
COMPLETED
Effect of Quetiapine on Sleep Architecture in Bipolar Depression and Major Depressive Disorder
Lead Sponsor:
Queen's University
Collaborating Sponsors:
AstraZeneca
Conditions:
Bipolar Disorder
Eligibility:
All Genders
18-65 years
Brief Summary
Clinical practice indicates that Quetiapine has sedating properties, and its sedative effects may play an important role in restoring quality of sleep in patients with various psychiatric conditions w...
Detailed Description
Primary Objective: To assess the objective (polysomnographic) change in sleep quality before and after introduction of Seroquel (Quetiapine) in treatment of patients with Bipolar Depression or Major ...
Eligibility Criteria
Inclusion
- Provision of written informed consent;
- A diagnosis of Bipolar Disorder Type 1,2 or NOS by Diagnostic and Statistical Manual of Mental Disorders- Fourth Edition (DSM-IV);OR Major Depressive Disorder
- Males or Females aged 18 years or more;
- 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;
- Current depressive episode with a HAM-D17 score of 15 or more.
Exclusion
- Current Manic, Hypomanic or Mixed episode, with YMRS 12 or more;
- Current or past diagnosis of Schizophrenia;
- Pregnant women, or women in childbearing age, not willing to use appropriate contraception or women currently nursing;
- Patient on 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 quetiapine fumarate, as judged by the investigator;
- Use of any of the following cytochrome P450 3A4 inhibitors in the 14 days preceding enrolment including but not limited to: ketoconazole, itraconazole, fluconazole, erythromycin, clarithromycin, troleandomycin, indinavir, nelfinavir, ritonavir, fluvoxamine and saquinavir;
- Use of any of the following cytochrome P450 inducers in the 14 days preceding enrolment including but not limited to: phenytoin, carbamazepine, barbiturates, rifampin, St. John's Wort, and glucocorticoids;
- Administration of a depot antipsychotic injection within one dosing interval (for the depot) before randomization;
- Substance or alcohol dependence at enrolment (except dependence in full remission, and except for caffeine or nicotine dependence), as defined by DSM-IV criteria;
- Opiates, amphetamine, barbiturate, cocaine, cannabis, or hallucinogen dependence by DSM-IV criteria within 4 weeks prior to enrolment;
- Medical conditions that would affect absorption, distribution, metabolism, or excretion of study treatment;
- Unstable or inadequately treated medical illness (e.g., diabetes, angina pectoris, hypertension) as judged by the investigator;
- 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;
- If participant's liver function testing is rated 2 in the upper limits of normal.
- Diagnosis of Dementia
- Regular use of benzodiazepines unless at a stable dose for at least 12 weeks.
Key Trial Info
Start Date :
May 1 2006
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 1 2009
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00616889
Start Date
May 1 2006
End Date
January 1 2009
Last Update
December 16 2015
Active Locations (1)
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1
Pccc, Mhs
Kingston, Ontario, Canada, K7L 4X3