FDA Approves Cariprazine as an Adjunctive Treatment for Major Depressive Disorder

The USFDA has approved the first and only dopamine and serotonin partial agonist, namely cariprazine, as an adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD) in adults. It can also be used for treating depressive episodes associated with bipolar I disorder.

The drug is an oral, once-daily atypical antipsychotic drug. Two clinical studies were conducted to study the safety and efficacy of the drug: (i) A randomized, double-blind, placebo-controlled, multicenter trial with 751 participants (Study 3111-301-001) (ii) A randomized, double-blind, placebo-controlled, flexible-dose, outpatient, multicenter trial with 808 participants (RGH-MD-75) Recommended dose The recommended doses in adults: MDD: 1.5 or 3 mg/day Bipolar depression: 1.5 or 3 mg/day Manic or mixed episodes associated with bipolar I disorder: 3 to 6 mg/day Schizophrenia: 1.5 to 6 mg/day…