A Double-Blind, Placebo-Controlled Trial of Asenapine in the Prevention of Recurrence of a Mood Episode After Stabilization of an Acute Manic/Mixed Episode in Subjects With Bipolar 1 Disorder (Phase 3B, Protocol P06384).
Phase of Trial: Phase III
Latest Information Update: 10 Oct 2017
At a glance
- Drugs Asenapine (Primary)
- Indications Bipolar I disorders
- Focus Registrational; Therapeutic Use
- Sponsors Actavis; Forest Laboratories; Merck Sharp & Dohme
- 26 Sep 2017 According to results published in the American Journal of Psychiatry, study protocol was amended with relapse rate assumptions updated to 34% for the placebo group (hazard ratio=0.45) and to 17% for the asenapine group.
- 26 Sep 2017 Primary endpoint (Time to recurrence of any mood event during the Double-Blind Treatment Period) has been met, according to results published in the American Journal of Psychiatry.
- 26 Sep 2017 Results published in the American Journal of Psychiatry.