Date: 2015-01-12
Type of information: Initiation of the trial
phase: 2a
Announcement: initiation of the trial
Company: Sage Therapeutics (USA - MA)
Product: SAGE-547
Action
mechanism: Allosteric modulator. SAGE-547 is an allosteric modulator of both synaptic and extra-synaptic GABAA receptors. GABAA receptors are widely regarded as validated drug targets for a variety of disorders, with decades of research and multiple approved drugs targeting these receptor systems. SAGE-547 is an intravenous agent in Phase 1/2 clinical development as an adjunctive therapy, a therapy combined with current therapeutic approaches, for the treatment of super-refractory status epilepticus (SRSE), as well as in exploratory Phase 2 clinical trials for the treatment of essential tremor and as an adjunctive therapy for the treatment of severe postpartum depression (PPD). In 2014, the FDA granted both Fast Track and orphan drug designation to SAGE-547 for the treatment of SRSE.
Disease: postpartum depression
Therapeutic area: CNS diseases - Mental diseases - Women health
Country: USA
Trial
details: This Phase 2a trial is an open-label study of SAGE-547 as an adjunctive therapy, or treatment given with current therapeutic approaches, in patients with severe PPD. This trial is expected to enroll at least 10 women with severe PPD who have experienced a major depressive episode within four weeks following delivery. This trial is designed to provide data regarding safety, tolerability and the acute effect of SAGE-547 on depressive symptoms as measured by the Hamilton Rating Scale for Depression (HAM-D) and Clinical Global Impression-Improvement Scale (CGI-I), respectively. Patients will be administered SAGE-547 intravenously for 48 hours and will be monitored for up to 30 days following treatment. The study is being conducted by Samantha Meltzer-Brody, M.D., Director of the Perinatal Psychiatry Program, University of North Carolina Center for Women\'s Mood Disorders and Principal Investigator of the study. (NCT02285504)
Latest
news: * On January 12, 2015, Sage Therapeutics, a clinical-stage biopharmaceutical company developing novel medicines to treat life-threatening, rare central nervous system disorders, announced dose administration of the first patient in a Phase 2a clinical trial of SAGE-547, an allosteric modulator of GABAA receptors, in women with severe postpartum depression (PPD). This trial is designed to evaluate the safety, tolerability, pharmacokinetics and efficacy of SAGE-547 for the treatment of severe PPD.
