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Bipolar Study of Seroquel XR With Pramipexole Dihydrochloride

Primary Purpose

Bipolar Depression

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
quetiapine (Seroquel) XR
quetiapine (Seroquel) XR
placebo
pramipexole dihydrochloride
Sponsored by
Dr. D McIntosh & Dr. K Kjernisted Clinical Research Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bipolar Depression focused on measuring bipolar, bipolar depression, bipolar disorder, depression, quetiapine, pramipexole, Seroquel XR, Mirapex

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Affiliated Research Institute
  • Eastside Therapeutic Resource
  • Dr. P. Chokka
  • Penticton Regional
  • Copeman Neuroscience Centre
  • AK Munshi Medical Inc.
  • Regional Mental Health Care - London
  • Hôpital Louis-H.Lafontaine
  • Clinique Marie Fitzbach

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Experimental

Arm Label

1

2

3

Arm Description

Quetiapine XR 300mg + Placebo

Quetiapine XR 300mg + Pramipexole 0.25mg

Quetiapine XR 300mg + Pramipexole 0.50mg

Outcomes

Primary Outcome Measures

Montgomery-Asberg Depression Rating Scale (MADRS) total score

Secondary Outcome Measures

The mean change in MADRS total score
Proportion of subjects achieving remission (MADRS score of less than or equal to 10)
Proportion of subjects achieving response (reduction of at least 50% in MADRS total score)
Mean change in HAM-D 21 total score
Proportion of subjects achieving remission (HAM-D 21 total score of less than or equal to 7)
Proportion of subjects achieving treatment response (reduction of at least 50% in HAM-D 21 total score)
Mean change in Vancouver Semi-Structured Interview for Depression (V-SID) total score
Proportion of subjects withdrawing from study due to inadequate control of depressive symptoms
Change in neurocognitive function, assessed by CNS Vital Signs
Change in neuroimmune biological markers
Adverse events and patient withdrawal due to adverse events
Treatment emergent mania
Treatment-emergent extra-pyramidal symptoms
Metabolic effects

Full Information

First Posted
May 4, 2009
Last Updated
February 1, 2013
Sponsor
Dr. D McIntosh & Dr. K Kjernisted Clinical Research Inc.
Collaborators
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT00893841
Brief Title
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

2. Study Status

Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
February 2009 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
January 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dr. D McIntosh & Dr. K Kjernisted Clinical Research Inc.
Collaborators
AstraZeneca

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar Depression
Keywords
bipolar, bipolar depression, bipolar disorder, depression, quetiapine, pramipexole, Seroquel XR, Mirapex

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
96 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Placebo Comparator
Arm Description
Quetiapine XR 300mg + Placebo
Arm Title
2
Arm Type
Experimental
Arm Description
Quetiapine XR 300mg + Pramipexole 0.25mg
Arm Title
3
Arm Type
Experimental
Arm Description
Quetiapine XR 300mg + Pramipexole 0.50mg
Intervention Type
Drug
Intervention Name(s)
quetiapine (Seroquel) XR
Other Intervention Name(s)
Seroquel XR
Intervention Description
tablets and caplets, take with liquid before bedtime
Intervention Type
Drug
Intervention Name(s)
quetiapine (Seroquel) XR
Other Intervention Name(s)
Seroquel XR
Intervention Description
tablets, take with liquid before bedtime
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
placebo
Intervention Type
Drug
Intervention Name(s)
pramipexole dihydrochloride
Other Intervention Name(s)
mirapex
Intervention Description
tablets and caplets, take with liquid before bedtime
Primary Outcome Measure Information:
Title
Montgomery-Asberg Depression Rating Scale (MADRS) total score
Time Frame
Week 0 to Week 16
Secondary Outcome Measure Information:
Title
The mean change in MADRS total score
Time Frame
Week 0 to Week 8
Title
Proportion of subjects achieving remission (MADRS score of less than or equal to 10)
Time Frame
Week 16
Title
Proportion of subjects achieving response (reduction of at least 50% in MADRS total score)
Time Frame
Week 0 to Week 16
Title
Mean change in HAM-D 21 total score
Time Frame
Week 0 to Week 16
Title
Proportion of subjects achieving remission (HAM-D 21 total score of less than or equal to 7)
Time Frame
Week 16
Title
Proportion of subjects achieving treatment response (reduction of at least 50% in HAM-D 21 total score)
Time Frame
Week 0 to Week 16
Title
Mean change in Vancouver Semi-Structured Interview for Depression (V-SID) total score
Time Frame
Week 0 to Week 16
Title
Proportion of subjects withdrawing from study due to inadequate control of depressive symptoms
Time Frame
Week 0 - 16
Title
Change in neurocognitive function, assessed by CNS Vital Signs
Time Frame
Week 0 to Week 16
Title
Change in neuroimmune biological markers
Time Frame
Week 0 to Week 16
Title
Adverse events and patient withdrawal due to adverse events
Time Frame
Week 0 - Week 16
Title
Treatment emergent mania
Time Frame
Week 0 - Week 16
Title
Treatment-emergent extra-pyramidal symptoms
Time Frame
Week 0 - Week 16
Title
Metabolic effects
Time Frame
Week 0 - Week 16

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Affiliated Research Institute
City
San Diego
State/Province
California
ZIP/Postal Code
92108
Country
United States
Facility Name
Eastside Therapeutic Resource
City
Kirkland
State/Province
Washington
ZIP/Postal Code
98033
Country
United States
Facility Name
Dr. P. Chokka
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6L 6W6
Country
Canada
Facility Name
Penticton Regional
City
Penticton
State/Province
British Columbia
ZIP/Postal Code
V2A 4M4
Country
Canada
Facility Name
Copeman Neuroscience Centre
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6Z 2L4
Country
Canada
Facility Name
AK Munshi Medical Inc.
City
Sydney
State/Province
Nova Scotia
ZIP/Postal Code
B1S 2E8
Country
Canada
Facility Name
Regional Mental Health Care - London
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4H1
Country
Canada
Facility Name
Hôpital Louis-H.Lafontaine
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1N 3M5
Country
Canada
Facility Name
Clinique Marie Fitzbach
City
Quebec
ZIP/Postal Code
G1R 2W8
Country
Canada

12. IPD Sharing Statement

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Bipolar Study of Seroquel XR With Pramipexole Dihydrochloride

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