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: 100000004873MedDRA version: 20.0Level: LLTClassification code 10008525Term: Childhood schizophreniaSystem Organ Class: 100000004873Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]
- Registration Number
- EUCTR2019-000470-36-BG
- Lead Sponsor
- Sunovion Pharmaceuticals Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 525
• Male or female subject between 13 to 65 years of age (inclusive) at the time of consent.
• Subject meets DSM-5 criteria for schizophrenia as established by clinical interview at Screening (using the DSM-5 as a reference and confirmed using the Structured Clinical Interview for DSM-5, Clinical Trials Version [SCID-CT] and using the Schedule for Affective Disorders and Schizophrenia for School-age Children [K-SADS-PL] for adolescents) at Screening.
• Information supporting a diagnosis of schizophrenia must be obtained
from additional sources to confirm the Screening evaluation of
schizophrenia diagnosis. This should include medical records and/or
documented correspondence with a treating psychiatrist or mental
healthcare provider/staff but can also include information from a reliable informant who is familiar with the subject's psychiatric history
(eg, family member, caregiver, case worker, etc.). The adequacy of the
information will be assessed by the Sponsor or designee during the
eligibility adjudication process. Exception: For adult subjects
experiencing their first psychotic episode or who have not previously
been seen by a psychiatrist or mental healthcare provider,
documentation of schizophrenia diagnosis by a psychiatrist or mental
healthcare provider 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 (or has not attained expected level of functioning for adolescents) in one or more areas, such as occupational, social, or personal care or hygiene.
• Subject has had no more than 2 prior lifetime inpatient hospitalizations for the treatment of an acute psychotic episode or exacerbation of schizophrenia(not including hospitalization at the time of Screening,
during Screening or at Baseline).Hospitalization history must be
informed by sources other than the subject's own report. This should
include medical records and/or documented correspondence with a
treating psychiatrist or mental healthcare provider/staff but can also
include information from a reliable informant who is familiar with the
subject's psychiatric history (eg, family member, caregiver, case worker,
etc.). The adequacy of the information will be assessed by the Sponsor
or designee during the eligibility adjudication process.
Are the trial subjects under 18? yes
Number of subjects for this age range: 90
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 435
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 Main Objective: To evaluate the efficacy of fixed doses of SEP-363856 (50 and 75 mg/day) compared with placebo in acutely psychotic adult subjects with schizophrenia as measured by the Positive and Negative Syndrome Scale (PANSS) total score.<br><br>Adolescent subjects are included in order to evaluate the consistency of treatment effects between adult and adolescent subjects and for the characterization of safety profile in this age group.;Secondary Objective: To evaluate the efficacy of fixed doses of SEP-363856 (50 and 75 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) in adult subjects. ;Timepoint(s) of evaluation of this end point: Week 6
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Change from Baseline in CGI-S score at Endpoint (Week 6) in adult subjects. ;Timepoint(s) of evaluation of this end point: Week 6