12 Week Study of the Safety/Efficacy of Asenapine When Added to Lithium/Valproate in the Treatment of Bipolar Disorder (A7501008 / P05844 / MK-8274-017)
NCT ID: NCT00145470
Last Updated: 2024-05-21
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
326 participants
INTERVENTIONAL
2005-06-02
2007-03-22
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Asenapine
Participants received asenapine as a fast-dissolving sublingual (SL) tablet, given twice daily (BID). On Day 1, participants received asenapine 5 mg, BID. On Days 2 to 84, asenapine was dosed flexibly: BID at either 5 or 10 mg. Asenapine doses were up- or down-titrated based on efficacy, safety, and tolerability.
Asenapine
Asenapine fast dissolving SL tablets 5 and 10 mg; starting dose 5 mg BID on Day 1; 5-10 mg BID after Day 1.
Placebo
Participants received placebo on Days 1-84 as a fast-dissolving SL tablet, BID.
Placebo
Placebo fast dissolving SL tablets, BID
Interventions
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Asenapine
Asenapine fast dissolving SL tablets 5 and 10 mg; starting dose 5 mg BID on Day 1; 5-10 mg BID after Day 1.
Placebo
Placebo fast dissolving SL tablets, BID
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Treated with lithium or valproic acid
Exclusion Criteria
* Clinically significant laboratory abnormality.
* Have a primary diagnosis other than bipolar I disorder.
18 Years
ALL
No
Sponsors
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Organon and Co
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
References
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Szegedi A, Calabrese JR, Stet L, Mackle M, Zhao J, Panagides J; Apollo Study Group. Asenapine as adjunctive treatment for acute mania associated with bipolar disorder: results of a 12-week core study and 40-week extension. J Clin Psychopharmacol. 2012 Feb;32(1):46-55. doi: 10.1097/JCP.0b013e31823f872f.
Other Identifiers
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A7501008
Identifier Type: OTHER
Identifier Source: secondary_id
2004-003927-11
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
MK-8274-017
Identifier Type: OTHER
Identifier Source: secondary_id
P05844
Identifier Type: OTHER
Identifier Source: secondary_id
P05844
Identifier Type: -
Identifier Source: org_study_id
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