Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
333 participants
INTERVENTIONAL
2002-09-30
2003-11-30
Brief Summary
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PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation was changed to XR after consultation with FDA.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
TRIPLE
Study Groups
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1
1st fixed dose
Quetiapine Fumarate
2
2nd fixed dose
Quetiapine Fumarate
3
Placebo
Placebo
Interventions
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Quetiapine Fumarate
Quetiapine Fumarate
Placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subjects exhibit inappropriate verbal, vocal, or motor activity that requires treatment with an antipsychotic medication in addition to or beyond behavioural modification therapy
* Subject must have a score of at least 14 on the PANSS
Exclusion Criteria
* Symptoms of agitation that are caused by another general medical condition or direct physiological effects of a substance
* Failure to respond on 2 occasions to an adequate regimen of atypical antipsychotic medications for the treatment of agitation and/or aggression
55 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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AstraZeneca
Other Identifiers
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D1446L00002
Identifier Type: -
Identifier Source: secondary_id
5077US/0046
Identifier Type: -
Identifier Source: org_study_id
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