- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00893841
Bipolar Study of Seroquel XR With Pramipexole Dihydrochloride
A Randomized, Double-Blind, Placebo Controlled Exploratory Study of Augmentation of Seroquel XR With Pramipexole Dihydrochloride for Bipolar Depression
Study Overview
Status
Conditions
Intervention / Treatment
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 rate is approximately 60%. Pramipexole, which is currently used to treat Parkinson's disease and restless legs syndrome, is reported to have antidepressant effects in patients with unipolar or bipolar depression. There are no other clinical studies to evaluate the efficacy of pramipexole combined with an atypical antipsychotic, such as quetiapine XR, in the treatment of bipolar depression.
This study is a multicentre, randomized, double-blind and placebo-controlled exploratory study in which patients will receive one of three treatment arms for a treatment period of 16 weeks: quetiapine XR plus placebo, quetiapine XR plus 0.25mg pramipexole, or quetiapine XR plus 0.50mg pramipexole.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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-
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Quebec, Canada, G1R 2W8
- Clinique Marie Fitzbach
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Alberta
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Edmonton, Alberta, Canada, T6L 6W6
- Dr. P. Chokka
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British Columbia
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Penticton, British Columbia, Canada, V2A 4M4
- Penticton Regional
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Vancouver, British Columbia, Canada, V6Z 2L4
- Copeman Neuroscience Centre
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Nova Scotia
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Sydney, Nova Scotia, Canada, B1S 2E8
- AK Munshi Medical Inc.
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Ontario
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London, Ontario, Canada, N6A 4H1
- Regional Mental Health Care - London
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Quebec
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Montreal, Quebec, Canada, H1N 3M5
- Hôpital Louis-H.Lafontaine
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-
-
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California
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San Diego, California, United States, 92108
- Affiliated Research Institute
-
-
Washington
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Kirkland, Washington, United States, 98033
- Eastside Therapeutic Resource
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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 Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: 1
Quetiapine XR 300mg + Placebo
|
placebo
tablets and caplets, take with liquid before bedtime
Other Names:
tablets, take with liquid before bedtime
Other Names:
|
Experimental: 2
Quetiapine XR 300mg + Pramipexole 0.25mg
|
tablets and caplets, take with liquid before bedtime
Other Names:
tablets, take with liquid before bedtime
Other Names:
tablets and caplets, take with liquid before bedtime
Other Names:
|
Experimental: 3
Quetiapine XR 300mg + Pramipexole 0.50mg
|
tablets and caplets, take with liquid before bedtime
Other Names:
tablets, take with liquid before bedtime
Other Names:
tablets and caplets, take with liquid before bedtime
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Montgomery-Asberg Depression Rating Scale (MADRS) total score
Time Frame: Week 0 to Week 16
|
Week 0 to Week 16
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The mean change in MADRS total score
Time Frame: Week 0 to Week 8
|
Week 0 to Week 8
|
Proportion of subjects achieving remission (MADRS score of less than or equal to 10)
Time Frame: Week 16
|
Week 16
|
Proportion of subjects achieving response (reduction of at least 50% in MADRS total score)
Time Frame: Week 0 to Week 16
|
Week 0 to Week 16
|
Mean change in HAM-D 21 total score
Time Frame: Week 0 to Week 16
|
Week 0 to Week 16
|
Proportion of subjects achieving remission (HAM-D 21 total score of less than or equal to 7)
Time Frame: Week 16
|
Week 16
|
Proportion of subjects achieving treatment response (reduction of at least 50% in HAM-D 21 total score)
Time Frame: Week 0 to Week 16
|
Week 0 to Week 16
|
Mean change in Vancouver Semi-Structured Interview for Depression (V-SID) total score
Time Frame: Week 0 to Week 16
|
Week 0 to Week 16
|
Proportion of subjects withdrawing from study due to inadequate control of depressive symptoms
Time Frame: Week 0 - 16
|
Week 0 - 16
|
Change in neurocognitive function, assessed by CNS Vital Signs
Time Frame: Week 0 to Week 16
|
Week 0 to Week 16
|
Change in neuroimmune biological markers
Time Frame: Week 0 to Week 16
|
Week 0 to Week 16
|
Adverse events and patient withdrawal due to adverse events
Time Frame: Week 0 - Week 16
|
Week 0 - Week 16
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Treatment emergent mania
Time Frame: Week 0 - Week 16
|
Week 0 - Week 16
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Treatment-emergent extra-pyramidal symptoms
Time Frame: Week 0 - Week 16
|
Week 0 - Week 16
|
Metabolic effects
Time Frame: Week 0 - Week 16
|
Week 0 - Week 16
|
Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Behavioral Symptoms
- Mental Disorders
- Mood Disorders
- Bipolar and Related Disorders
- Depression
- Depressive Disorder
- Bipolar Disorder
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Protective Agents
- Antipsychotic Agents
- Tranquilizing Agents
- Psychotropic Drugs
- Antidepressive Agents
- Dopamine Agonists
- Dopamine Agents
- Antioxidants
- Antiparkinson Agents
- Anti-Dyskinesia Agents
- Quetiapine Fumarate
- Pramipexole
Other Study ID Numbers
- D1443C00032
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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