Bipolar Study of Seroquel XR With Pramipexole Dihydrochloride

Bipolar Depression Clinical Trial

Official title:

A Randomized, Double-Blind, Placebo Controlled Exploratory Study of Augmentation of Seroquel XR With Pramipexole Dihydrochloride for Bipolar Depression

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00893841
• Other study ID #: D1443C00032
• Status: Completed
• Phase: Phase 2
• First received: May 4, 2009
• Last updated: February 1, 2013
• Start date: February 2009
• Est. completion date: January 2013

Study information

• Verified date: February 2013
• Source: Dr. D McIntosh & Dr. K Kjernisted Clinical Research Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bipolar Depression
• Bipolar Disorder
• Depression
• Depressive Disorder

Intervention

Drug:
• quetiapine (Seroquel) XR
tablets and caplets, take with liquid before bedtime
• quetiapine (Seroquel) XR
tablets, take with liquid before bedtime
• placebo
placebo
• pramipexole dihydrochloride
tablets and caplets, take with liquid before bedtime

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Dr. D McIntosh & Dr. K Kjernisted Clinical Research Inc.	AstraZeneca

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Montgomery-Asberg Depression Rating Scale (MADRS) total score		Week 0 to Week 16	No
Secondary	The mean change in MADRS total score		Week 0 to Week 8	No
Secondary	Proportion of subjects achieving remission (MADRS score of less than or equal to 10)		Week 16	No
Secondary	Proportion of subjects achieving response (reduction of at least 50% in MADRS total score)		Week 0 to Week 16	No
Secondary	Mean change in HAM-D 21 total score		Week 0 to Week 16	No
Secondary	Proportion of subjects achieving remission (HAM-D 21 total score of less than or equal to 7)		Week 16	No
Secondary	Proportion of subjects achieving treatment response (reduction of at least 50% in HAM-D 21 total score)		Week 0 to Week 16	No
Secondary	Mean change in Vancouver Semi-Structured Interview for Depression (V-SID) total score		Week 0 to Week 16	No
Secondary	Proportion of subjects withdrawing from study due to inadequate control of depressive symptoms		Week 0 - 16	No
Secondary	Change in neurocognitive function, assessed by CNS Vital Signs		Week 0 to Week 16	No
Secondary	Change in neuroimmune biological markers		Week 0 to Week 16	No
Secondary	Adverse events and patient withdrawal due to adverse events		Week 0 - Week 16	Yes
Secondary	Treatment emergent mania		Week 0 - Week 16	Yes
Secondary	Treatment-emergent extra-pyramidal symptoms		Week 0 - Week 16	Yes
Secondary	Metabolic effects		Week 0 - Week 16	Yes