40 Week Trial to Study the Safety of Asenapine When Added to Lithium or Valproate in the Treatment of Bipolar Disorder (A7501009)(P05786)

Organon

Status and phase: Completed; Phase 3

Conditions: Bipolar Disorder

Treatments: Drug: Placebo; Drug: Asenapine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00145509

A7501009

P05786

Details and patient eligibility

About

The primary objective of this trial was to characterize the long-term (up to 40 weeks) safety and tolerability of asenapine in bipolar I disorder subjects who had not completely responded to continuing treatment with lithium or valproic acid (VPA) for the treatment of an acute manic or mixed episodes upon enrollment into the 12-week lead-in trial, A7501008 (NCT00145470). The safety comparison was between the group receiving lithium or VPA and placebo against the group receiving lithium or VPA and asenapine, with the caveat that all subjects may have received benzodiazepine and/or antidepressant rescue medication as needed.

Enrollment: 77 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Have bipolar I disorder (current episode manic or mixed), be treated with lithium or valproic acid, and have completed the a 12-week lead-in trial

Exclusion criteria

• Have an unstable medical condition or clinically significant laboratory abnormality.
• Have a primary diagnosis other than bipolar I disorder.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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77 participants in 2 patient groups, including a placebo group

Asenapine

Active Comparator group

Description:

Asenapine

Treatment:

Drug: Asenapine

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo