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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)

NCT00145470 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 326

Last updated 2024-05-21

Study results available
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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.

Conditions

Interventions

DRUG

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.

DRUG

Placebo

Placebo fast dissolving SL tablets, BID

Sponsors & Collaborators

  • Organon and Co

    lead INDUSTRY

Principal Investigators

  • Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-06-02
Primary Completion
2007-02-28
Completion
2007-03-22

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00145470 on ClinicalTrials.gov