Bipolar Study of Seroquel XR With Pramipexole Dihydrochloride

NCT00893841 | Completed Phase 2

• 1 other identifier: D1443C00032
• Study Type: interventional
• Target: 96
• Locations: 2 countries
• Sites: 9

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.

Conditions

Bipolar Depression

Keywords

bipolar; bipolar depression; bipolar disorder; depression; quetiapine; pramipexole; Seroquel XR; Mirapex

Outcome Measures

Primary Outcomes (1)

• Montgomery-Asberg Depression Rating Scale (MADRS) total score

  Week 0 to Week 16

Secondary Outcomes (14)

• The mean change in MADRS total score

  Week 0 to Week 8

• Proportion of subjects achieving remission (MADRS score of less than or equal to 10)

  Week 16

• Proportion of subjects achieving response (reduction of at least 50% in MADRS total score)

  Week 0 to Week 16

• Mean change in HAM-D 21 total score

  Week 0 to Week 16

• Proportion of subjects achieving remission (HAM-D 21 total score of less than or equal to 7)

  Week 16

Study Arms (3)

1

PLACEBO COMPARATOR

Quetiapine XR 300mg + Placebo

Drug: quetiapine (Seroquel) XR; Drug: placebo

2

EXPERIMENTAL

Quetiapine XR 300mg + Pramipexole 0.25mg

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

3

EXPERIMENTAL

Quetiapine XR 300mg + Pramipexole 0.50mg

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

Interventions

quetiapine (Seroquel) XR DRUG

tablets and caplets, take with liquid before bedtime

Also known as: Seroquel XR

2; 3

placebo DRUG

placebo

1

pramipexole dihydrochloride DRUG

tablets and caplets, take with liquid before bedtime

Also known as: mirapex

2; 3

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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,

Sponsors & Collaborators

• Dr. D McIntosh & Dr. K Kjernisted Clinical Research Inc.: lead
• AstraZeneca: collaborator

Study Sites (9)

Affiliated Research Institute

San Diego, California, 92108, United States

Location

Eastside Therapeutic Resource

Kirkland, Washington, 98033, United States

Location

Dr. P. Chokka

Edmonton, Alberta, T6L 6W6, Canada

Location

Penticton Regional

Penticton, British Columbia, V2A 4M4, Canada

Location

Copeman Neuroscience Centre

Vancouver, British Columbia, V6Z 2L4, Canada

Location

AK Munshi Medical Inc.

Sydney, Nova Scotia, B1S 2E8, Canada

Location

Regional Mental Health Care - London

London, Ontario, N6A 4H1, Canada

Location

Hôpital Louis-H.Lafontaine

Montreal, Quebec, H1N 3M5, Canada

Location

Clinique Marie Fitzbach

Québec, Quebec, G1R 2W8, Canada

Location

MeSH Terms

Conditions

Bipolar Disorder; Depression

Interventions

Quetiapine Fumarate; Pramipexole

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Dibenzothiazepines; Thiazepines; Thiepins; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Benzothiazoles; Thiazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds, 2-Ring

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2009
• First Posted: May 6, 2009
• Study Start: February 1, 2009
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: February 4, 2013

Record last verified: 2013-02

Locations

US (2); CA (7)