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SEP-363856

Aliases
SEP-363856 50 mg, SEP-363856 75mg, SEP-363856 75 mg

19 clinical trials

4 indications

Indication
Major Depressive Disorder
Indication
Schizophrenia
Indication
Generalized Anxiety Disorder
Indication
Parkinson disease psychosis
Clinical trial
A Phase 2/3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of the Safety and Efficacy of Flexible Doses of SEP-363856 as Adjunctive Therapy in the Treatment of Adults With Major Depressive Disorder
Status: Recruiting, Estimated PCD: 2025-05-01
Clinical trial
An 8-Week, Open-Label Study Evaluating the Effectiveness, Safety and Tolerability of SEP-363856 in Subjects With Schizophrenia Switched From Typical or Atypical Antipsychotic Agents
Status: Active (not recruiting), Estimated PCD: 2024-07-24
Clinical trial
An Open-Label, Fixed Sequence, Multiple Dose Study of Glucose and Insulin Associated Parameters: SEP-363856 vs Prior Antipsychotic (PA) Standard of Care in Subjects With Schizophrenia Suffering From Metabolic Dysregulation
Status: Completed, Estimated PCD: 2023-08-22
Clinical trial
A Phase 2/3, Randomized, Double-blind, Parallel Group, Placebo-controlled, Flexible-dose, Multicenter Study to Evaluate the Efficacy and Safety of SEP-363856 in the Treatment of Adults With Generalized Anxiety Disorder
Status: Recruiting, Estimated PCD: 2025-02-08
Clinical trial
A Double-Blind, Placebo-Controlled, Randomized Withdrawal Study to Evaluate SEP-363856 Physical Dependence in Adult Subjects With Schizophrenia
Status: Completed, Estimated PCD: 2024-03-15
Clinical trial
An Open-label Extension Study to Assess the Safety and Tolerability of SEP-363856 in Subjects With Schizophrenia
Status: Terminated, Estimated PCD: 2023-11-09
Clinical trial
A Randomized, Double-blind, Parallel-group, Placebo Controlled, Fixed-dose, Multicenter Study to Evaluate the Efficacy and Safety of SEP 363856 in Acutely Psychotic Patients With Schizophrenia, Followed by an Open-label Extension Phase
Status: Terminated, Estimated PCD: 2023-10-12
Clinical trial
A 52-week, Open-label Study to Evaluate the Long-term Safety and Tolerability of SEP-363856 in Patients With Schizophrenia in Japan
Status: Terminated, Estimated PCD: 2024-03-21
Clinical trial
An Open-label Extension Study to Assess the Safety and Tolerability of SEP-363856 in Subjects With Schizophrenia Switched From Typical or Atypical Antipsychotic Agents
Status: , Estimated PCD: 2025-01-10
Clinical trial
A Randomized, Double-blind, Parallel-group, Placebo-controlled, Fixed-dose, Multicenter Study to Evaluate the Efficacy and Safety of SEP-363856 in Acutely Psychotic Subjects With Schizophrenia
Status: Completed, Estimated PCD: 2023-05-12
Clinical trial
A Multicenter Randomized Double-blind Followed by an Open-label Extension Study to Evaluate the Efficacy, Safety, and Tolerability of SEP-363856 in Subjects With Parkinson's Disease Psychosis
Status: Completed, Estimated PCD: 2020-04-20
Clinical trial
An Open-Label Positron Emission Tomography Study to Investigate the Effect of Adjunctive Administration of SEP-363856 on Brain Dopamine Synthesis Capacity Using 18F-DOPA in Adult Subjects With Schizophrenia
Status: Completed, Estimated PCD: 2023-06-06
Clinical trial
A Randomized, Double-blind, Parallel-group, Placebo-controlled, Fixed-dose, Multicenter Study to Evaluate the Efficacy and Safety of SEP-363856 in Acutely Psychotic Subjects With Schizophrenia
Status: Completed, Estimated PCD: 2023-06-14
Clinical trial
A 2-Part Randomized Single-Blind, Placebo-Controlled, Ascending Multiple Oral Dose and Open-Label Study Assessing the Safety, Tolerability, and Pharmacokinetics of SEP-363856 in Male and Female Subjects With Schizophrenia
Status: Completed, Estimated PCD: 2014-12-01
Clinical trial
A Randomized, Single-blind, Two-period Crossover to Investigate the Effect of SEP-363856 on the Pharmacokinetics of Metformin in Subjects With Schizophrenia.
Status: Completed, Estimated PCD: 2022-05-03
Clinical trial
A Randomized Single-Blind, Placebo-Controlled, Ascending Single Oral Dose Study Assessing the Safety, Tolerability, and Pharmacokinetics of SEP-363856 in Male and Female Subjects With Schizophrenia.
Status: Completed, Estimated PCD: 2014-03-01
Clinical trial
A Randomized, Double-blind, Placebo-controlled, Single-dose, Study of the Effects of SEP 363856 and Amisulpride on BOLD-fMRI Signal in Healthy Male and Female Volunteers With High or Low Schizotype Characteristics.
Status: Completed, Estimated PCD: 2015-07-01
Clinical trial
A 26-Week Open-label Safety and Tolerability Extension Study of SEP-363856 in Adult Subjects With Schizophrenia
Status: Completed, Estimated PCD: 2019-01-29
Clinical trial
A 4-Week, Randomized, Double-blind, Parallel-group, Placebo-controlled, Flexibly-dosed, Multicenter Study to Evaluate the Efficacy and Safety of SEP-363856 in Acutely Psychotic Adult Subjects With Schizophrenia
Status: Completed, Estimated PCD: 2018-07-31