Adult Bipolar Mania
Tracking Information
Start Date ICMJE | June 2009 |
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Primary Completion Date | |
Current Primary Outcome Measures ICMJE (submitted: July 1, 2009) | Change in the YMRS total score from baseline to final assessment (Day 43). [ Time Frame: Will be scored at enrollment visit and then once a week for 6 weeks ] [ Designated as safety issue: No ] |
Original Primary Outcome Measures ICMJE | Same as current |
Change History | Complete list of historical versions of study NCT00931723 on ClinicalTrials.gov Archive Site |
Current Secondary Outcome Measures ICMJE (submitted: July 1, 2009) |
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Original Secondary Outcome Measures ICMJE | Same as current |
Descriptive Information
Brief Title ICMJE | Adult Bipolar Mania |
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Official Title ICMJE | An International, Multicenter, Double-blind, Randomized, Placebo-controlled, Phase IV Study of the Safety and Efficacy of Lithium Versus Placebo as an Add on to SEROQUEL XR (Quetiapine Fumarate) in Adult Patients With Acute Mania |
Brief Summary | The purpose of this study is to determine if lithium 600-1800 mg/day is effective when added to quetiapine fumarate extended release (quetiapine XR or SEROQUEL® XR) 400-800 mg/day in treating acute mania and if so, how it compares with placebo (a non-active capsule, like a sugar pill, that looks like lithium). |
Detailed Description | |
Study Phase | Phase IV |
Study Type ICMJE | Interventional |
Study Design ICMJE | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study |
Condition ICMJE | Acute Mania |
Intervention ICMJE |
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Study Arms / Comparison Groups |
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Recruitment Information
Estimated Enrollment ICMJE | 350 | ||||
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Estimated Completion Date | July 2010 | ||||
Primary Completion Date | |||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 18 Years to 65 Years | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE |
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Location Countries ICMJE | Belgium, Bulgaria, Germany, India, Israel, Poland, Russian Federation, South Africa, Ukraine |
Administrative Information
NCT ID ICMJE | NCT00931723 | ||||||||
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Responsible Party | MSD, AstraZeneca Pharmaceuticals | ||||||||
Study ID Numbers ICMJE | D144AC00003 | ||||||||
Study Sponsor ICMJE | AstraZeneca | ||||||||
Collaborators ICMJE | Quintiles | ||||||||
Investigators ICMJE |
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Information Provided By | AstraZeneca |
Source: http://clinicaltrials.gov/