Bipolar Study of Seroquel XR With Pramipexole Dihydrochloride

Completed · Phase 2 · Has a placebo group

Conditions studied: Bipolar Depression

In brief

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 investigated in this study is improved treatment of bipolar depression.

Key facts

Study ID

NCT00893841

Run by

Dr. D McIntosh & Dr. K Kjernisted Clinical Research Inc.

People needed

96

Starts

2009-02-01

Expected to finish

2013-01-01

Last updated by the study team

2013-02-04

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Affiliated Research Institute — San Diego, California, United States
• Eastside Therapeutic Resource — Kirkland, Washington, United States
• Dr. P. Chokka — Edmonton, Alberta, Canada
• Penticton Regional — Penticton, British Columbia, Canada
• Copeman Neuroscience Centre — Vancouver, British Columbia, Canada
• AK Munshi Medical Inc. — Sydney, Nova Scotia, Canada
• Regional Mental Health Care - London — London, Ontario, Canada
• Hôpital Louis-H.Lafontaine — Montreal, Quebec, Canada
• Clinique Marie Fitzbach — Québec, Quebec, Canada

Full record on ClinicalTrials.gov

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