Minerva screens first patient in Phase 2b trial of MIN-117 to treat MDD
Minerva Neurosciences announced the screening of the first patient in a Phase 2b trial of MIN-117 to reduce the symptoms of patients diagnosed with major depressive disorder. The primary objective of the trial is to evaluate the efficacy of two fixed doses of MIN-117, 5.0 milligrams and 2.5 mg, compared with placebo in reducing the symptoms of major depression as measured by the change in the Montgomery-Asberg Depression Rating Scale total score over six weeks of treatment. Secondary objectives include: assessment of the change from baseline in symptoms of anxiety using the Hamilton Anxiety Scale; the change in severity of illness using the Clinical Global Impression of Severity Scale and Clinical Global Impression of Improvement Scale; and safety over six weeks of treatment. The study population will consist of adults with a diagnosis of moderate or severe MDD with anxious distress and without psychotic features. Based upon previous clinical observations, the company believes that patients with MDD who also have symptoms of anxiety may benefit from treatment with MIN-117. Approximately 324 patients are expected to be enrolled at approximately 40 sites in the U.S. and Europe. Patients will be randomized to one of three arms, including placebo and the two dosage arms, in a 2:1:1 ratio, resulting in approximately 162 patients in the placebo group and 81 patients in each of the two MIN-117 treatment groups. The study design includes a screening phase of up to three weeks, a six-week double-blind treatment phase and a two-week post- study follow-up period. Top line results of the trial are expected in 1H19.