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.
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
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
96
tablets and caplets, take with liquid before bedtime
tablets, take with liquid before bedtime
placebo
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
Montgomery-Asberg Depression Rating Scale (MADRS) total score
Time frame: Week 0 to Week 16
The mean change in MADRS total score
Time frame: Week 0 to Week 8
Proportion of subjects achieving remission (MADRS score of less than or equal to 10)
Time frame: Week 16
Proportion of subjects achieving response (reduction of at least 50% in MADRS total score)
Time frame: Week 0 to Week 16
Mean change in HAM-D 21 total score
Time frame: 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
Proportion of subjects achieving treatment response (reduction of at least 50% in HAM-D 21 total score)
Time frame: 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
Proportion of subjects withdrawing from study due to inadequate control of depressive symptoms
Time frame: Week 0 - 16
Change in neurocognitive function, assessed by CNS Vital Signs
Time frame: Week 0 to Week 16
Change in neuroimmune biological markers
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tablets and caplets, take with liquid before bedtime
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
Time frame: Week 0 to Week 16
Adverse events and patient withdrawal due to adverse events
Time frame: Week 0 - Week 16
Treatment emergent mania
Time frame: Week 0 - Week 16
Treatment-emergent extra-pyramidal symptoms
Time frame: Week 0 - Week 16
Metabolic effects
Time frame: Week 0 - Week 16