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

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ClinicalTrials.gov Identifier: NCT04092686
Recruitment Status : Recruiting
First Posted : September 17, 2019
Last Update Posted : October 15, 2019
Sponsor:
Information provided by (Responsible Party):
Sunovion

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 18 -65 years old who have been diagnosed with schizophrenia. This study will be conducted in 40 locations world wide. The study will last up to nine (9) weeks.

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: SEP-363856 75mg Drug: SEP-363856 100mg 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 (75 and 100 mg/day) versus placebo over a 6-week Treatment Period in acutely psychotic subjects with schizophrenia. This study is projected to randomize approximately 462 subjects to 3 treatment groups (SEP-363856 75 mg/day, SEP-363856 100 mg/day, or placebo) in a 1:1:1 ratio. 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 hypotheses 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 : 462 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A 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 30, 2019
Estimated Primary Completion Date : October 26, 2021
Estimated Study Completion Date : October 26, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: SEP-363856 75mg
SEP-363856 75mg dosed once daily
Drug: SEP-363856 75mg
SEP-363856 75mg tablet dosed once daily

Experimental: SEP-363856 100mg
SEP-363856 100mg dosed once daily
Drug: SEP-363856 100mg
SEP-363856 100mg 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:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female subject between 18 to 65 years of age (inclusive) at the time of consent.
  2. Subject must give written informed consent and privacy authorization prior to participation 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 ClinicalTrials.gov identifier (NCT number): NCT04092686


Contacts
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Contact: CNS Medical Director 1-866-503-6351 ClinicalTrialDisclosure@sunovion.com

Locations
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United States, Arkansas
Woodland Research Northwest Recruiting
Rogers, Arkansas, United States, 72758
Contact: Robert Billingsley, MD    479-927-3000      
United States, California
Collaborative Neuroscience Network Recruiting
Long Beach, California, United States, 90806
Contact: David Walling, MD    714-799-7799      
California Neuropsychopharmacology Clinical Research Institute Recruiting
San Diego, California, United States, 92102
Contact: Christopher Benbow, MD    619-481-5252      
Schuster Medical Research Institute Recruiting
Sherman Oaks, California, United States, 91403
Contact: Jose Itzcovich-Schuster, MD    818-788-0746      
United States, Louisiana
Lake Charles Clinical Trials Recruiting
Lake Charles, Louisiana, United States, 70629
Contact: Kashinath Yadalam, MD    337-564-6405      
United States, New Jersey
Hassman Research Institute Recruiting
Marlton, New Jersey, United States, 08053
Contact: Howard Hassman, MD    856-452-9901      
United States, Texas
Pillar Clinical Research Recruiting
Richardson, Texas, United States, 75080
Contact: Scott Bartley, MD    214-396-4844      
Latvia
SLLC Psychoneurological Hospital of Strenci Recruiting
Strenci, Latvia, LV-4730
Contact: Inga Bauska, MD    +37164731340      
Sponsors and Collaborators
Sunovion
Investigators
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Study Chair: CNS Medical Director Sunovion

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Responsible Party: Sunovion
ClinicalTrials.gov Identifier: NCT04092686     History of Changes
Other Study ID Numbers: 361-302
2019-000697-37 ( EudraCT Number )
First Posted: September 17, 2019    Key Record Dates
Last Update Posted: October 15, 2019
Last Verified: October 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 ct.gov.
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
URL: http://clinicalstudydatarequest.com

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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
Schizophrenia
Additional relevant MeSH terms:
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Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders