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

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.

Study Overview

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

Interventional

Enrollment (Actual)

96

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Quebec, Canada, G1R 2W8
        • Clinique Marie Fitzbach
    • Alberta
      • Edmonton, Alberta, Canada, T6L 6W6
        • Dr. P. Chokka
    • British Columbia
      • Penticton, British Columbia, Canada, V2A 4M4
        • Penticton Regional
      • Vancouver, British Columbia, Canada, V6Z 2L4
        • Copeman Neuroscience Centre
    • Nova Scotia
      • Sydney, Nova Scotia, Canada, B1S 2E8
        • AK Munshi Medical Inc.
    • Ontario
      • London, Ontario, Canada, N6A 4H1
        • Regional Mental Health Care - London
    • Quebec
      • Montreal, Quebec, Canada, H1N 3M5
        • Hôpital Louis-H.Lafontaine
    • California
      • San Diego, California, United States, 92108
        • Affiliated Research Institute
    • Washington
      • Kirkland, Washington, United States, 98033
        • Eastside Therapeutic Resource

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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:
  • Seroquel XR
tablets, take with liquid before bedtime
Other Names:
  • Seroquel XR
Experimental: 2
Quetiapine XR 300mg + Pramipexole 0.25mg
tablets and caplets, take with liquid before bedtime
Other Names:
  • Seroquel XR
tablets, take with liquid before bedtime
Other Names:
  • Seroquel XR
tablets and caplets, take with liquid before bedtime
Other Names:
  • mirapex
Experimental: 3
Quetiapine XR 300mg + Pramipexole 0.50mg
tablets and caplets, take with liquid before bedtime
Other Names:
  • Seroquel XR
tablets, take with liquid before bedtime
Other Names:
  • Seroquel XR
tablets and caplets, take with liquid before bedtime
Other Names:
  • mirapex

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
Treatment emergent mania
Time Frame: Week 0 - Week 16
Week 0 - Week 16
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

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2009

Primary Completion (Actual)

January 1, 2013

Study Completion (Actual)

January 1, 2013

Study Registration Dates

First Submitted

May 4, 2009

First Submitted That Met QC Criteria

May 5, 2009

First Posted (Estimate)

May 6, 2009

Study Record Updates

Last Update Posted (Estimate)

February 4, 2013

Last Update Submitted That Met QC Criteria

February 1, 2013

Last Verified

February 1, 2013

More Information

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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