Status:
COMPLETED
Bipolar Study of Seroquel XR With Pramipexole Dihydrochloride
Lead Sponsor:
Dr. D McIntosh & Dr. K Kjernisted Clinical Research Inc.
Collaborating Sponsors:
AstraZeneca
Conditions:
Bipolar Depression
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
This study is designed to assess the use of pramipexole dihydrochloride and quetiapine (Seroquel) XR as combination therapy for bipolar depression. The proposed benefit of the combination therapy inve...
Detailed Description
Quetiapine is a first-line option in Canadian guidelines for the treatment of bipolar depression; however, there is room for improvement as the remission rate is approximately 50% and the response rat...
Eligibility Criteria
Inclusion
- You must be between 18 years and 65 years of age.
- You must have been diagnosed with bipolar depression.
- You must (for women who are able to become pregnant) have a negative urine human chorionic gonadotropin (HCG) pregnancy test at enrolment and be using a reliable form of birth control for the entire duration of the study. The study staff will inform about what is considered an acceptable method of birth control.
- You must provide consent.
- You must be able to understand and comply with the requirements of the study
Exclusion
- You are pregnant or lactating (breast-feeding),
- Your symptoms are due to the direct physiological effects of a substance (e.g. drug of abuse, medication, or other treatment) or a general medical condition,
- You have a primary psychotic disorder (e.g., schizophrenia),
- You have a personality disorder diagnosis which in the study doctor's opinion is the focus of clinical concern.
- You have a history or presence of any psychotic illness, including major depression with psychotic features.
- In the opinion of the study doctor, you pose an imminent risk of suicide or a danger to yourself or others,
- You have known allergies to quetiapine or to components of the medication capsule,
- You use any "prohibited" medications. You must inform the study coordinator or study doctor of all the medications that you are taking, and he/she will tell you if any of those medications exclude you from the study.
- You have a substance dependence (drug or alcohol dependence) which in the study doctor's opinion is the focus of clinical concern,
- You have a medical condition that would affect absorption, distribution, metabolism, or excretion of the medication,
- You have an unstable or inadequately treated medical illness (e.g. unstable diabetes, angina pectoris, hypertension) as judged by the study doctor,
- You have diabetes mellitus (DM) which, in the opinion of the study doctor, would exclude you from the study,
- You have an absolute neutrophil count (ANC) of ≤1.5 x 109 per liter
- You are involved in the planning and conduct of the study ,
- You were previously enrolled or randomized in this present study,
- You participated in another drug trial within 4 weeks prior enrolment into this study
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2013
Estimated Enrollment :
96 Patients enrolled
Trial Details
Trial ID
NCT00893841
Start Date
February 1 2009
End Date
January 1 2013
Last Update
February 4 2013
Active Locations (9)
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1
Affiliated Research Institute
San Diego, California, United States, 92108
2
Eastside Therapeutic Resource
Kirkland, Washington, United States, 98033
3
Dr. P. Chokka
Edmonton, Alberta, Canada, T6L 6W6
4
Penticton Regional
Penticton, British Columbia, Canada, V2A 4M4