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)

Organon

Status and phase: Completed; Phase 3

Conditions: Bipolar Disorder

Treatments: Drug: Placebo; Drug: Asenapine

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

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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