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Positive Results Reported for Adjunctive Treatment With Caripazine in Patients With Major Depressive Disorder
Positive results have been reported from a phase IIb trial evaluating the efficacy and safety of the investigational antipsychotic agent cariprazine (Forest Laboratories/Gedeon Richter) as adjunctive treatment in adult patients with major depressive disorder (MDD) who have demonstrated an inadequate response to antidepressant therapy (ADT).
The trial included three treatment groups: cariprazine 1.0 to 2.0 mg/day plus ADT; cariprazine 2.0 to 4.5 mg/day plus ADT; and placebo plus ADT. The group that received cariprazine 2.0 to 4.5 mg/day plus ADT demonstrated statistically significant improvement in the Montgomery–Åsberg Depression Rating Scale (MADRS) total score compared with placebo at 8 weeks — the trial’s primary endpoint.
This international, randomized, double-blind, placebo-controlled, parallel-group, flexible-dose, 8-week phase IIb study evaluated the efficacy, safety, and tolerability of cariprazine as adjunctive treatment in adult patients with MDD who demonstrated an inadequate response to ADT. Eligible patients were those who met Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for MDD, had a minimum score of 22 on the MADRS scale, and had an ongoing inadequate response to ADT.
After a 7- to 14-day screening and washout period, a total of 819 patients between 18 and 65 years of age were randomly assigned to the three treatments, followed by a 1-week safety follow-up period. The primary endpoint was defined as change from baseline to the end of week 8 in the MADRS total score. Statistically significant improvement in the MADRS total score was observed in the patients treated with cariprazine 2.0 to 4.5 mg/day plus ADT compared with the patients given placebo plus ADT (–2.2 vs. –0.9, respectively; P = 0.0114).
The most common adverse events across both cariprazine groups were akathisia, nausea, insomnia, somnolence, and fatigue.
Cariprazine is an investigational, orally active dopamine D3-preferring D3/D2 receptor partial agonist atypical antipsychotic. The compound has a low affinity at other receptor sites, such as 5-HT2C, muscarinic, and adrenergic sites.
Cariprazine is being developed for the treatment of schizophrenia and bipolar mania in adults. In November 2013, the FDA issued a complete response letter regarding the new drug application for schizophrenia and bipolar mania. In addition, ongoing investigational clinical trials are evaluating cariprazine for the treatment of bipolar depression and as adjunctive treatment of MDD in adults.
MDD is a serious medical condition affecting approximately 16 million adults in the U.S. or about 7.3% of the adult U.S. population. The World Health Organization predicts that depression will become the second leading cause of disability by the year 2020.
Source: Forest Laboratories; March 21, 2014.