CompletedPhase 3

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)

326 participantsStarted 2005-06-02

Plain-language summary

This is a 12-week study that will test the safety and efficacy of asenapine when used in addition to lithium or valproate for subjects with acute manic or mixed episodes of Bipolar I Disorder.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Have bipolar I disorder, current episode manic or mixed * Treated with lithium or valproic acid Exclusion Criteria: * Have an unstable medical condition * Clinically significant laboratory abnormality. * Have a primary diagnosis other than bipolar I disorder.

What they're measuring

Least Squares Mean Change From Baseline in Young-Mania Rating Scale (Y-MRS) Score at Day 21

Timeframe: Baseline and Day 21

Trial details

NCT IDNCT00145470

SponsorOrganon and Co

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2007-02-28

Results submitted2019-04-29

View on ClinicalTrials.gov More Bipolar Disorder trials