Date: 2014-03-03
Type of information: Publication of results in a medical journal
phase: 3
Announcement: presentation of results at the European Psychiatry Association Congress
Company: Lundbeck (Denmark) Otsuka Pharmaceutical (Japan)
Product: brexpiprazole (7-[4-(4-benzo[b]thiophen-4-yl-piperazin-1-yl)butoxy]-1H-quinolin-2-one)
Action
mechanism: Brexpiprazole is a serotonin-dopamine activity modulator (SDAM) that acts as a partial agonist at 5-HT1A and dopamine D2 receptors at similar potency, and an antagonist at 5-HT2A and noradrenaline alpha1B/2C receptors.
Disease: major depressive disorder (MDD)
Therapeutic area: CNS diseases - Mental diseases
Country:
Trial
details: The study is a phase III, randomized, placebo-controlled study investigating the efficacy and safety of brexpiprazole as adjunctive therapy to antidepressant therapy (ADT) in subjects with Major Depressive Disorder (MDD) who demonstrated inadequate responses to ADT monotherapy. 379 patients were randomized to double-blind adjunctive brexpiprazole (2mg/day, n=188) or placebo (n=191).
Latest
news: * On March 3, 2014, Otsuka Pharmaceutical and Lundbeck A/S presented results from a completed phase III study of brexpiprazole in patients with major depressive disorder (MDD). Results were presented in a poster session at the 22nd European Psychiatry Association Congress (EPA). This phase III study showed statistically significant improvement in mean MADRS (Montgomery–Åsberg Depression Rating Scale) total score for patients receiving adjunctive brexpiprazole compared to patients receiving placebo. The primary efficacy endpoint of the phase III trial was the change in the MADRS total score during the 6-week randomized treatment phase. In addition, on all secondary endpoints brexpiprazole showed a statistically significant advantage over placebo. The most common adverse events (occurring in > 5% of brexpiprazole patients and a higher percentage than in patients receiving placebo) during this Phase III study were weight gain (8.0% vs. 1.5%) and akathisia (7.4% vs. 1.0%).
