Clinical trial NCT00893841: Bipolar Study of Seroquel XR With Pramipexole Dihydrochloride
Official title: A Randomized, Double-Blind, Placebo Controlled Exploratory Study of Augmentation of Seroquel XR With Pramipexole Dihydrochloride for Bipolar Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Bipolar Depression
Keywords: bipolar
bipolar depression
bipolar disorder
depression
quetiapine
pramipexole
Seroquel XR
Mirapex
Lead sponsor: Dr. D McIntosh & Dr. K Kjernisted Clinical Research Inc.
Sponsor class: OTHER
Collaborators: name: AstraZeneca
First posted: 2009-05-06
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 investigated in this study is improved treatment of bipolar depression.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Montgomery-Asberg Depression Rating Scale (MADRS) total score
timeFrame: Week 0 to Week 16
Secondary outcomes:
measure: The mean change in MADRS total score
timeFrame: Week 0 to Week 8
measure: Proportion of subjects achieving remission (MADRS score of less than or equal to 10)
timeFrame: Week 16
measure: Proportion of subjects achieving response (reduction of at least 50% in MADRS total score)
timeFrame: Week 0 to Week 16
measure: Mean change in HAM-D 21 total score
timeFrame: Week 0 to Week 16
measure: Proportion of subjects achieving remission (HAM-D 21 total score of less than or equal to 7)
timeFrame: Week 16
measure: Proportion of subjects achieving treatment response (reduction of at least 50% in HAM-D 21 total score)
timeFrame: Week 0 to Week 16
measure: Mean change in Vancouver Semi-Structured Interview for Depression (V-SID) total score
timeFrame: Week 0 to Week 16
measure: Proportion of subjects withdrawing from study due to inadequate control of depressive symptoms
timeFrame: Week 0 - 16
measure: Change in neurocognitive function, assessed by CNS Vital Signs
timeFrame: Week 0 to Week 16
measure: Change in neuroimmune biological markers
timeFrame: Week 0 to Week 16
measure: Adverse events and patient withdrawal due to adverse events
timeFrame: Week 0 - Week 16
measure: Treatment emergent mania
timeFrame: Week 0 - Week 16
measure: Treatment-emergent extra-pyramidal symptoms
timeFrame: Week 0 - Week 16
measure: Metabolic effects
timeFrame: Week 0 - Week 16
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Affiliated Research Institute
state: California
city: Kirkland
country: United States
facility: Eastside Therapeutic Resource
state: Washington
city: Edmonton
country: Canada
facility: Dr. P. Chokka
state: Alberta
city: Penticton
country: Canada
facility: Penticton Regional
state: British Columbia
city: Vancouver
country: Canada
facility: Copeman Neuroscience Centre
state: British Columbia
city: Sydney
country: Canada
facility: AK Munshi Medical Inc.
state: Nova Scotia
city: London
country: Canada
facility: Regional Mental Health Care - London
state: Ontario
city: Montreal
country: Canada
facility: Hôpital Louis-H.Lafontaine
state: Quebec
city: Quebec
country: Canada
facility: Clinique Marie Fitzbach
Study officials:
References: