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)

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Organon

Status and phase

Completed
Phase 3

Conditions

Bipolar Disorder

Treatments

Drug: Asenapine
Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT00145470
2004-003927-11 (EudraCT Number)
A7501008 (Other Identifier)
MK-8274-017 (Other Identifier)
P05844 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

326 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

326 participants in 2 patient groups, including a placebo group

Asenapine
Experimental group
Description:
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.
Treatment:
Drug: Asenapine
Placebo
Placebo Comparator group
Description:
Participants received placebo on Days 1-84 as a fast-dissolving SL tablet, BID.
Treatment:
Drug: Placebo

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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