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

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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

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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