Bipolar Study of Seroquel XR With Pramipexole Dihydrochloride - Full Text View

Sponsor:	Dr. D McIntosh & Dr. K Kjernisted Clinical Research Inc.
Collaborator:	AstraZeneca
Information provided by:	Dr. D McIntosh & Dr. K Kjernisted Clinical Research Inc.
ClinicalTrials.gov Identifier:	NCT00893841

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 II

Study Type:	Interventional
Study Design:	Allocation: Randomized Control: Placebo Control 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:

MedlinePlus related topics: Bipolar Disorder Depression

Drug Information available for: Pramipexol Quetiapine Quetiapine fumarate Pramipexole dihydrochloride

U.S. FDA Resources

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 [ 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 [ Designated as safety issue: Yes ]
Treatment emergent mania [ Designated as safety issue: Yes ]
Treatment-emergent extra-pyramidal symptoms [ Designated as safety issue: Yes ]
Metabolic effects [ Designated as safety issue: Yes ]

Estimated Enrollment:	96
Study Start Date:	February 2009
Estimated Study Completion Date:	January 2010
Estimated Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Placebo Comparator Quetiapine XR 300mg + Placebo	Drug: quetiapine (Seroquel) XR tablets, take with liquid before bedtime Drug: placebo placebo
2: Experimental Quetiapine XR 300mg + Pramipexole 0.25mg	Drug: quetiapine (Seroquel) XR tablets and caplets, take with liquid before bedtime Drug: pramipexole dihydrochloride tablets and caplets, take with liquid before bedtime
3: Experimental Quetiapine XR 300mg + Pramipexole 0.50mg	Drug: quetiapine (Seroquel) XR tablets and caplets, take with liquid before bedtime Drug: pramipexole dihydrochloride tablets and caplets, take with liquid before bedtime

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

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

Locations

Canada, British Columbia
Penticton Regional	Recruiting
Penticton, British Columbia, Canada, V2A 4M4
Contact: Amanda McIntyre 250-492-0053
Principal Investigator: Alexander McIntyre, MD
Copeman Neuroscience Centre	Recruiting
Vancouver, British Columbia, Canada, V6Z 2L4
Contact: Kim Walhof 604-707-2255
Principal Investigator: Kevin Kjernisted, MD
Sub-Investigator: Diane McIntosh, MD
Sub-Investigator: Andrew Hall, MD
Canada, Manitoba
Eden Mental Health	Recruiting
Winkler, Manitoba, Canada, R6W 1T4
Contact: Lois Patterson 204-325-4325
Principal Investigator: Larry Klassen, MD
Canada, Nova Scotia
AK Munshi Medical Inc.	Recruiting
Sydney, Nova Scotia, Canada, B1S 2E8
Contact: Donna Eagles 902-562-2323
Principal Investigator: Autar Munshi, MD

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. ( Dr. Kevin Kjernisted )
Study ID Numbers:	D1443C00032
Study First Received:	May 4, 2009
Last Updated:	October 23, 2009
ClinicalTrials.gov Identifier:	NCT00893841 History of Changes
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:

Neurotransmitter Agents
Antioxidants
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents
Physiological Effects of Drugs
Psychotropic Drugs
Antiparkinson Agents
Dopamine Agonists
Pramipexol
Affective Disorders, Psychotic
Mental Disorders
Therapeutic Uses
Depression

Tranquilizing Agents
Bipolar Disorder
Central Nervous System Depressants
Depressive Disorder
Antipsychotic Agents
Protective Agents
Pharmacologic Actions
Behavioral Symptoms
Quetiapine
Mood Disorders
Dopamine Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on March 18, 2010