A phase 3 randomized placebo-controlled double-blinded trial evaluating the safety and efficacy of asenapine in subjects continuing lithium or valproic acid/divalproex sodium for the treatment of an acute manic or mixed episode
Phase of Trial: Phase III
Latest Information Update: 29 Apr 2015
At a glance
- Drugs Asenapine (Primary)
- Indications Bipolar I disorders
- Focus Registrational; Therapeutic Use
- Acronyms APOLLO
- Sponsors Merck & Co; Organon; Pfizer; Schering-Plough
- 03 Sep 2010 Asenapine has been approved in the EU for the treatment of moderate to severe manic episodes associated with bipolar I disorder in adults based on the results of this trial and the monotherapy ARES trials, according to a Merck media release.
- 22 May 2010 Results have been presented at the 163rd Annual Meeting of the American Psychiatric Association (APA).
- 06 Oct 2009 Schering-Plough added as trial sponsor and affiliate as reported by ClinicalTrials.gov.
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History