Schizophrenia MedDRA version: 21.1 Level: LLT Classification code 10001064 Term: Acute schizophrenia System Organ Class: 100000004873
Conditions
Sponsors
Sunovion Pharmaceuticals Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Male or female subject between 18 to 65 years of age (inclusive) at the time of consent. • Subject meets DSM-5 criteria for schizophrenia as established by clinical interview (using the DSM-5 as a reference and confirmed using the Structured Clinical Interview at Screening for DSM-5, Clinical Trials Version [SCID-CT]). • Medical records and/or documented correspondence with a previous or current treating psychiatrist are required. These records should support that the clinical course and previous treatment are consistent with schizophrenic illness. For subjects experiencing their first psychotic episode or who have not previously been seen by a psychiatrist, documentation of schizophrenia diagnosis by a psychiatrist other than the trial Investigator or Sub-Investigator is required. • Subject must have a CGI-S score = 4 at Screening and Baseline. • Subject must have a PANSS total score = 80 and a PANSS item score = 4 on 2 or more of the following PANSS items: delusions, conceptual disorganization, hallucinations, and unusual thought content at Screening and Baseline. • Subject has an acute exacerbation of psychotic symptoms (persisting no longer than 2 months prior to providing informed consent for this study). • Subject has marked deterioration of functioning in one or more areas, such as occupational, social, or personal care or hygiene. • Subject has had no more than 3 prior lifetime inpatient hospitalizations for the treatment of an acute psychotic episode or exacerbation of schizophrenia. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 552 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Subject has had a decrease (improvement of symptoms) of = 20% on the PANSS total score between Screening and Baseline. • Subject has been hospitalized for more than 2 consecutive weeks immediately before screening, unless the hospitalization was for reasons unrelated to acute psychotic exacerbation. • Subject has a DSM-5 diagnosis or presence of symptoms consistent with a DSM-5 diagnosis other than schizophrenia. Exclusionary disorders include but are not limited to alcohol use disorder (within past 12 months or for a total of = 10 years during the subject's lifetime ), substance (other than nicotine or caffeine) use disorder within past 12 months or for a total of = 10 years during the subject's lifetime, major depressive disorder, bipolar I or II disorder, schizoaffective disorder, obsessive compulsive disorder, and posttraumatic stress disorder. Symptoms of mild to moderate mood dysphoria or anxiety are allowed so long as these symptoms are not the primary focus of treatment. • Subject is judged to be resistant to antipsychotic treatment by the Investigator, based on failure to respond to 2 or more marketed antipsychotic agents within a 1-year period prior to Screening, given at an adequate dose as per labeling, for at least 4 weeks. • Subject answers “yes” to “Suicidal Ideation” Item 4 (active suicidal ideation with some intent to act, without specific plan) or Item 5 (active suicidal ideation with specific plan and intent) on the C-SSRS assessment at Screening (i.e., in the past one month) or Baseline (i.e., since last visit). • Subject is at significant risk of harming self, others, or objects based on Investigator’s judgment. • Subject has attempted suicide within 6 months prior to Screening. • Subject is involuntarily hospitalized. • Subject has any clinically significant unstable medical condition or any clinically significant chronic disease that in the opinion of the Investigator, would limit the subject's ability to complete and/or participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of fixed doses of SEP-363856 (75 and 100 mg/day) compared with placebo in acutely psychotic adult subjects with schizophrenia as measured by the Positive and Negative Syndrome Scale (PANSS) total score.;Secondary Objective: To evaluate the efficacy of fixed doses of SEP-363856 (75 and 100 mg/day) compared with placebo in acutely psychotic adult subjects with schizophrenia as measured by the Clinical Global Impression-Severity (CGI-S) score.;Primary end point(s): Change from Baseline in PANSS total score at Endpoint (Week 6).;Timepoint(s) of evaluation of this end point: Week 6 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Change from Baseline in CGI-S score at Endpoint (Week 6).;Timepoint(s) of evaluation of this end point: Week 6 | — |
Countries
Bulgaria, Latvia, Russian Federation, Serbia, Ukraine, United States
Contacts
Public ContactMedical Director
IQVIA
Outcome results
None listed