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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00107731




Registration number
NCT00107731
Ethics application status
Date submitted
7/04/2005
Date registered
8/04/2005
Date last updated
25/03/2009

Titles & IDs
Public title
Efficacy & Safety of Seroquel Plus Mood Stabilizer in the Maintenance of Bipolar I Disorder
Scientific title
A Multicenter, Randomized, Parallel-Group, Double-Blind, Phase 3 Comparison of the Efficacy & Safety of Quetiapine Fumarate to Placebo When Used as Adjunct to Mood Stabilizers (Lithium or Valproate) in the Maintenance Treatment of Bipolar I Disorder in Adult Patients (Abbreviated)
Secondary ID [1] 0 0
D1447C00126
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bipolar I Disorder 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - quetiapine fumarate
Treatment: Drugs - lithium
Treatment: Drugs - divalproex

Treatment: Drugs: quetiapine fumarate


Treatment: Drugs: lithium


Treatment: Drugs: divalproex
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Evaluate the efficacy of quetiapine versus placebo when used as adjunct therapy to mood stabilizer in increasing time to recurrence of a mood event.
Timepoint [1] 0 0
Secondary outcome [1] 0 0
Evaluate the efficacy of quetiapine versus placebo when used as a adjunct therapy to mod stabilizer in increasing time to recurrence of a manic event
Timepoint [1] 0 0

Eligibility
Key inclusion criteria
- A diagnosis of Bipolar I Disorder, Most recent episode Manic (296.4x), or Bipolar I
Disorder, Most Recent Episode Depressed (296.5x), or Bipolar I Disorder, Most recent
Episode Mixed (296.6x), with or without psychotic features, as defined by Diagnostic
and Statistical Manual of Mental Disorders - Fourth Edition (DSM-IV)

- At least 1 manic, depressed, or mixed episode in the 2 years prior to the index
episode.

- Able to understand and comply with the requirements of the study.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Diagnosis of an anxiety disorder as defined by DSM-IV, which was treated with
medication within the past year.

- Known intolerance or lack of response to quetiapine fumarate or to the assigned mood
stabilizer, as judged by the investigator.

- Previously randomized into this study or D1447C00126

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/04/2004
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/10/2006
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
Research Site - Greenwich
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Research Site - Brisbane
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Research Site - Everton Park
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Research Site - Southport
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Research Site - Glenside
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Research Site - Box Hill
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Research Site - Dandenong
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Research Site - Epping
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Research Site - Richmond
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- Greenwich
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- Brisbane
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- Everton Park
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- Southport
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- Glenside
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- Box Hill
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- Dandenong
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- Epping
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- Richmond
Recruitment outside Australia
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Wisconsin
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Assebroek
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Brussels
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Gent
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Kortenberg
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Manage
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Waregem
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Sofia
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Varna
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Jeseník
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Litomolice
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Olomouc
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Praha 10
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Helsinki
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Seinajoki
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Welwyn Garden City

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
AstraZeneca
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to determine whether quetiapine when used as adjunct to lithium
or divalproex is safe and effective in the maintenance treatment of adult patients with
Bipolar I Disorder. The study consists of enrollment and 2 phases, the Open-label treatment
Phase and the Randomized treatment Phase.

PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation
was changed to XR after consultation with FDA.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00107731
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
AstraZeneca Seroquel Medical Science Director, MD
Address 0 0
AstraZeneca
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00107731