Current Trials

Title: An Open-label Study to Assess the Long-term Safety, Tolerability, and Efficacy of KarXT in De Novo Subjects With DSM-5 Schizophrenia
Sponsor: Karuna Therapeutics
Study Phase: 3
Study Sites: Approximately 60 sites in the United States
Indication: Schizophrenia
Primary Objective: The primary objective of the study is to assess the long-term safety and tolerability of KarXT in subjects with a Diagnostic and Statistical Manual-Fifth Addition (DSM-5) diagnosis of schizophrenia.
Title: A Multi-region, Multicenter, Randomized, Double-blind, Placebo-Controlled, Parallel-Group Study Evaluating SEP-4199 Controlled Release (CR) for the Treatment of Major Depressive Episode Associated with Bipolar I disorder (Bipolar I Depression)
Sponsor: Sunovion Pharmaceuticals Inc.; Sponsor in Japan: Sumitomo in Dainippon Pharma Co. Ltd.
Study Phase: 3
Study Sites: Up to 90 sites in Europe (EUR), Japan (JP), and the United States (US)
Indication: Major depressive episode associated with bipolar I disorder (bipolar I depression)
Primary Objective: The objective of Study SEP380-301 is to evaluate the safety, efficacy, and tolerability of SEP-4199 CR formulation given as monotherapy at fixed doses of 200 mg/day and 400 mg/day compared with placebo in the treatment of subjects with major depressive episode associated with bipolar I disorder (bipolar I depression).
Title: A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of NV-5138 in Adults with Treatment Resistant Depression
Sponsor: Navitor Pharmaceuticals, Inc.
Study Phase: 2
Study Sites: Approximately 35 sites are planned in the US.
Indication: Treatment Resistant Depression (TRD)
Primary Objective: To evaluate the efficacy of NV-5138 compared to placebo when administered to adults with TRD.