4 week Multicenter Study to Evaluate the Efficacy and Safety of SEP-363856 in Acutely Psychotic Adult Subjects With Schizophrenia
- Conditions
- SchizophreniaMedDRA version: 19.0Level: HLGTClassification code 10039628Term: Schizophrenia and other psychotic disordersSystem Organ Class: 10037175 - Psychiatric disordersTherapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]
- Registration Number
- EUCTR2016-001555-41-HU
- Lead Sponsor
- SUNOVION PHARMACEUTICALS INC.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 278
To qualify for participation, subjects must meet all of the following inclusion criteria:
Inclusion criteria (not all inclusive):
To qualify for participation, subjects must meet all of the following inclusion criteria:
1.Male or female subject between 18 to 40 years of age (inclusive) at the time of consent.
2.Subject meets DSM_5 criteria for a primary diagnosis of schizophrenia as established by clinical interview (using the DSM_5 as a reference and confirmed using the SCID_CT). The duration of the subject's illness whether treated or untreated must be = 6 months.
3.Subject must have a CGI_S score = 4 (moderate or greater) at screening and Baseline.
4.Subject must have a PANSS total score = 80 and a PANSS subscale score = 4 (moderate) on 2 or more of the following PANSS subscale items: delusions, conceptual disorganization, hallucinations, and unusual thought content at screening and Baseline.
5.Subject has an acute exacerbation of psychotic symptoms (no longer than 2 months) and marked deterioration of function from Baseline (by history) AND subject has been hospitalized for the purpose of treating an acute psychotic exacerbation for 2 consecutive weeks or less immediately before screening.
Subjects who have been hospitalized for more than 2 weeks for reasons unrelated to acute exacerbation can be included with concurrence from the Medical Monitor that such hospitalization was other than acute relapse. For example, subjects in a long-term hospital setting who have an acute exacerbation and are transferred to an acute unit are eligible for the study.
6.Subject has had no more than 2 prior hospitalizations for treatment of acute exacerbation of schizophrenia (not including the current hospitalization).
7.At Baseline, subject must have a total score < 5 on the SAS.
Randomization Criteria
To qualify for randomization, subjects must meet all of the following randomization criteria:
1.Subject must have a PANSS total score = 80 at Baseline (Day 1).
2.Subject must have a PANSS subscale score = 4 on 2 or more of the following PANSS subscale items: delusions, conceptual disorganization, hallucinations, and unusual thought content at Baseline (Day 1).
3.Subject must have a CGI_S score = 4 at Baseline (Day 1).
4.Subject must have a total score < 5 on the SAS at Baseline (Day 1).
5.Subject must not answer 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 Baseline (ie, since last visit).
Subject must meet all other inclusion and none of the exclusion criteria at Baseline (Day 1).
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 278
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria (not all inclusive):
To qualify for participation, subjects must not meet any of the following exclusion criteria:
1.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 (ie, in the past one month) and at Baseline (ie, since last visit).
2.Subject has previously received SEP_363856.
3.Subject has a lifelong history or presence of symptoms consistent with a major psychiatric disorder other than primary schizophrenia as defined by DSM-V unless symptoms were rediagnosed as consistent with primary schizophrenia. Exclusionary disorders include but are not limited to alcohol use disorder (within past 12 months), substance (other than nicotine or caffeine) use disorder within past 12 months, major depressive disorder, bipolar depression, mania, schizoaffective disorder, obsessive compulsive disorder, posttraumatic stress disorder. Previous or current symptoms of mild to moderate mood dysphoria or anxiety are allowed so long as these symptoms have not been a focus of primary treatment.
4.Subject is at significant risk of harming him/herself or others according to the Investigator's judgment.
5.Subject has attempted suicide within 3 months prior to screening
6.Subject is involuntarily hospitalized.
7.Subject is receiving a total dose of antipsychotic medication equivalent to > 12.0mg/day of haloperidol at Screening.
8.Subject has received electroconvulsive therapy treatment within the 6 months prior to screening or is expected to require ECT during the study.
9.Subject has had past episodes of significant extrapyramidal symptoms (EPS) under current medication that required dose modification or the addition of anti-Parkinson's treatment within the last 6 months.
10.Subject is considered resistant to antipsychotic treatment by the Investigator, defined as failure to respond to 2 or more marketed antipsychotic agents, given at adequate dose for at least 4 weeks (28 days) within 1 year (365 days) before Screening (eg, the subject was hospitalized because of worsening psychotic symptoms due to insufficient clinical response or required frequent use of other antipsychotic drugs on a temporary basis).
11.Subject has a history of treatment with clozapine for refractory psychosis and/or subject has been treated with clozapine (for any reason) within 4 months of Screening.
12.Subject is currently participating, or has participated in, a study with an investigational or marketed compound or device within 6 months prior to signing the informed consent, or has participated in 2 or more studies within 24 months prior to signing the informed consent
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 flexibly dosed SEP-363856 (50 or 75 mg/day) compared with placebo in acutely psychotic adult subjects with schizophrenia as measured by the Positive and Negative Syndrome Scale (PANSS).;Secondary Objective: To evaluate the efficacy of flexibly-dosed SEP-363856 (50 or 75 mg/day) compared with placebo in acutely psychotic adult subjects with schizophrenia.;Primary end point(s): Change from Baseline in PANSS total score at Week 4;Timepoint(s) of evaluation of this end point: Week 4
- Secondary Outcome Measures
Name Time Method