Bipolar Study of Seroquel XR With Pramipexole Dihydrochloride

This study has been completed.
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Dr. D McIntosh & Dr. K Kjernisted Clinical Research Inc.
ClinicalTrials.gov Identifier:
NCT00893841
First received: May 4, 2009
Last updated: February 1, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention Phase
Bipolar Depression
Drug: quetiapine (Seroquel) XR
Drug: placebo
Drug: pramipexole dihydrochloride
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo Controlled Exploratory Study of Augmentation of Seroquel XR With Pramipexole Dihydrochloride for Bipolar Depression

Resource links provided by NLM:


Further study details as provided by Dr. D McIntosh & Dr. K Kjernisted Clinical Research Inc.:

Primary Outcome Measures:
  • Montgomery-Asberg Depression Rating Scale (MADRS) total score [ Time Frame: Week 0 to Week 16 ] [ Designated as safety issue: No ]

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

Enrollment: 96
Study Start Date: February 2009
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1
Quetiapine XR 300mg + Placebo
Drug: quetiapine (Seroquel) XR
tablets, take with liquid before bedtime
Other Name: Seroquel XR
Drug: placebo
placebo
Experimental: 2
Quetiapine XR 300mg + Pramipexole 0.25mg
Drug: quetiapine (Seroquel) XR
tablets and caplets, take with liquid before bedtime
Other Name: Seroquel XR
Drug: pramipexole dihydrochloride
tablets and caplets, take with liquid before bedtime
Other Name: mirapex
Experimental: 3
Quetiapine XR 300mg + Pramipexole 0.50mg
Drug: quetiapine (Seroquel) XR
tablets and caplets, take with liquid before bedtime
Other Name: Seroquel XR
Drug: pramipexole dihydrochloride
tablets and caplets, take with liquid before bedtime
Other Name: mirapex

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00893841

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

No publications provided

Responsible Party: Dr. D McIntosh & Dr. K Kjernisted Clinical Research Inc.
ClinicalTrials.gov Identifier: NCT00893841     History of Changes
Other Study ID Numbers: D1443C00032
Study First Received: May 4, 2009
Last Updated: February 1, 2013
Health Authority: Canada: Health Canada

Keywords provided by Dr. D McIntosh & Dr. K Kjernisted Clinical Research Inc.:
bipolar
bipolar depression
bipolar disorder
depression
quetiapine
pramipexole
Seroquel XR
Mirapex

Additional relevant MeSH terms:
Bipolar Disorder
Depression
Depressive Disorder
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders
Behavioral Symptoms
Pramipexole
Quetiapine
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs

ClinicalTrials.gov processed this record on August 21, 2014