Bipolar Study of Seroquel XR With Pramipexole Dihydrochloride

Condition(s) targeted: Bipolar Depression

Intervention: quetiapine (Seroquel) XR (Drug); quetiapine (Seroquel) XR (Drug); placebo (Drug); pramipexole dihydrochloride (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: Dr. D McIntosh & Dr. K Kjernisted Clinical Research Inc.

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.

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

Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Montgomery-Asberg Depression Rating Scale (MADRS) total score

Secondary outcome:

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

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.

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

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

Penticton Regional, Penticton, British Columbia V2A 4M4, Canada; Recruiting
Amanda McIntyre, Phone: 250-492-0053
Alexander McIntyre, MD, Principal Investigator

Copeman Neuroscience Centre, Vancouver, British Columbia V6Z 2L4, Canada; Recruiting
Kim Walhof, Phone: 604-707-2255
Kevin Kjernisted, MD, Principal Investigator
Diane McIntosh, MD, Sub-Investigator
Andrew Hall, MD, Sub-Investigator

Eden Mental Health, Winkler, Manitoba R6W 1T4, Canada; Recruiting
Lois Patterson, Phone: 204-325-4325
Larry Klassen, MD, Principal Investigator

AK Munshi Medical Inc., Sydney, Nova Scotia B1S 2E8, Canada; Recruiting
Donna Eagles, Phone: 902-562-2323
Autar Munshi, MD, Principal Investigator

Starting date: February 2009
Ending date: January 2010
Last updated: May 5, 2009