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A Clinical Trial to Study the Efficacy and Safety of an Investigational Drug in Acutely Psychotic People With Schizophrenia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04072354
Recruitment Status : Recruiting
First Posted : August 28, 2019
Last Update Posted : October 1, 2019
Information provided by (Responsible Party):

Brief Summary:
A clinical trial to study the efficacy and safety of an investigational drug in acutely psychotic people with schizophrenia. Participants in the study will either receive the drug being studied or a placebo. This study is accepting male and female participants between 13 years old -65 years old who have been diagnosed with schizophrenia. This study will be conducted in 50 locations worldwide. The study will last up to 9 weeks total time.

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: SEP-363856 50mg Drug: SEP-363856 75mg Drug: Placebo Phase 3

Detailed Description:

This is a multicenter, randomized, double-blind, parallel-group, fixed-dosed study evaluating the efficacy and safety of two doses of SEP-363856 (50 and 75 mg/day) versus placebo over a 6-week Treatment Period in acutely psychotic subjects with schizophrenia. This study is projected to randomize approximately 435 subjects (18-65 years) to 3 treatment groups (SEP-363856 50 mg/day, SEP-363856 75 mg/day, or placebo) in a 1:1:1 ratio. In addition, the study will randomize approximately 90 adolescent subjects (13-17 years) in a 1:1:1 ratio to the 3 treatment groups (with approximately 30 subjects per group) in a separate cohort. Treatment assignment will be stratified by country. Study drug will be taken once a day and may be taken with or without food.

This study is designed to test the hypothesis that, treatment with SEP-363856 in adult subjects with schizophrenia will result in significantly greater reduction (i.e. improvement) in PANSS total score and CGI-S score at Week 6 from Baseline when compared to placebo. The overall Type I error is controlled for two hierarchical families of hypotheses. The first family includes hypotheses about the testing of change from Baseline in PANSS total score at Week 6 between each of the SEP-363856 dose levels vs. placebo. The second family of hypotheses are about the testing of change from Baseline in CGI-S score at Week 6 between each of the SEP-363856 dose levels vs. placebo.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 525 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: randomized, double-blind, parallel-group, placebo controlled, fixed-dose multicenter study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: double-blind
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : September 11, 2019
Estimated Primary Completion Date : September 3, 2021
Estimated Study Completion Date : September 3, 2021

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: SEP-363856 50mg
SEP-363856 50mg dosed once daily
Drug: SEP-363856 50mg
SEP-363856 50mg tablet dosed once daily

Experimental: SEP-363856 75mg
SEP-363856 75mg dosed once daily
Drug: SEP-363856 75mg
SEP-363856 75mg tablet dosed once daily

Placebo Comparator: Placebo
Placebo dosed once daily
Drug: Placebo
Placebo tablet dosed once daily

Primary Outcome Measures :
  1. Change from Baseline in Positive and negative syndrome scale (PANSS) total score at Endpoint (Week 6) [ Time Frame: Baseline and Week 6 ]
    PANSS is comprised of 30 items and 3 subscales (Positive, Negative, General Psychopathology). An anchored Likert scale from 1 - 7, where values of 2 and above indicate the presence of progressively more severe symptoms, is used to score each item. Individual items are then summed to determine scores for the 3 subscales, as well as a total score. PANSS Positive subscale score range: 7-49. PANSS Negative subscale score range: 7-49. PANSS General Psychopathology subscale score range: 16-112. PANSS total score range: 30-210.

Secondary Outcome Measures :
  1. Change from Baseline in Clinical Global Impressions - Severity (CGI-S) score at Endpoint (Week 6) [ Time Frame: Baseline and Week 6 ]
    The CGI-S is a single-item clinician-rated assessment of the subject's current illness state on a 7-point scale (score range: 1-7), where a higher score is associated with greater illness severity.

Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Male or female subject between 13 to 65 years of age (inclusive) at the time of consent.
  2. Subject or subjects parent/legal guardian [adolescents] must give written informed consent and privacy authorization prior to participate in the study; adolescents must also provide informed assent..
  3. Subject meets DSM-5 criteria for schizophrenia as established by clinical interview
  4. Subject must have a CGI-S score ≥ 4
  5. 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
  6. Subject has an acute exacerbation of psychotic symptoms (persisting no longer than 2 months prior to providing informed consent).
  7. Subject has marked deterioration of functioning in one or more areas.
  8. Subject is, in the opinion of the Investigator, generally healthy based on screening medical history, PE, neurological examination, vital signs, and clinical laboratory values.

Exclusion Criteria:

  1. 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), substance (other than nicotine or caffeine) use disorder within past 12 months, 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.
  2. Subject is at significant risk of harming self, others, or objects based on Investigator's judgment.
  3. 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:
  4. Female subject who is pregnant or lactating
  5. Subject has any clinically significant abnormal laboratory value(s) at Screening

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04072354

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Contact: CNS Medical Director 1-866-503-6351

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United States, Arkansas
Woodland International Research Group, LLC Recruiting
Little Rock, Arkansas, United States, 72211
Contact: Jim Aukstuolis, MD    501-221-8681      
United States, California
Synergy San Diego Recruiting
Lemon Grove, California, United States, 91945
Contact: Mohammed Bari, MD    619-303-6130      
California Neuropsychopharmacology Clinical Research Institute (CNRI-LA, LLC) Recruiting
Pico Rivera, California, United States, 90660
Contact: Raymond Manning, MD    562-928-8601      
United States, Florida
Research Centers of America Recruiting
Hollywood, Florida, United States, 33024
Contact: Peter Ventre, MD    954-990-7649      
United States, Georgia
Atlantic Center for Medical Research Recruiting
Atlanta, Georgia, United States, 30331
Contact: Robert Risenberg, MD         
United States, Maryland
CBH Health, LLC Recruiting
Gaithersburg, Maryland, United States, 20877
Contact: Robert Litman, MD    301-251-4702      
United States, Ohio
Midwest Clinical Research Center Recruiting
Dayton, Ohio, United States, 45417
Contact: Otto Dueno, MD    937-424-1052      
United States, Texas
Community Clinical Research Recruiting
Austin, Texas, United States, 78754
Contact: David Brown, MD    512-323-2622      
Sponsors and Collaborators
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Study Chair: CNS Medical Director Sunovion Pharmaceuticals In.

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Responsible Party: Sunovion Identifier: NCT04072354     History of Changes
Other Study ID Numbers: SEP361-301
2019-000470-36 ( EudraCT Number )
First Posted: August 28, 2019    Key Record Dates
Last Update Posted: October 1, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: IPD for this study may be made available upon request via the Clinical Study Data Request site
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: IPD will be made available upon request within 12 months of posting the study results on
Access Criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sunovion:
acute psychosis
Additional relevant MeSH terms:
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Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders