A study to evaluate the efficacy of fixed doses of SEP-363856 compared with placebo in acutely psychotic subjects with schizophrenia.
- Conditions
- SchizophreniaMedDRA version: 21.1Level: LLTClassification code 10001064Term: Acute schizophreniaSystem Organ Class: 100000004873Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]
- Registration Number
- EUCTR2019-000697-37-LV
- Lead Sponsor
- Sunovion Pharmaceuticals Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 552
• 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
• 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method