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

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

Sponsors

Lead sponsor: Sunovion

Source 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.

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.

Overall Status Recruiting
Start Date September 30, 2019
Completion Date October 26, 2021
Primary Completion Date October 26, 2021
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Change from Baseline in Positive and negative syndrome scale (PANSS) total score at Endpoint (Week 6) Baseline and Week 6
Secondary Outcome
Measure Time Frame
Change from Baseline in Clinical Global Impressions - Severity (CGI-S) score at Endpoint (Week 6) Baseline and Week 6
Enrollment 462
Condition
Intervention

Intervention type: Drug

Intervention name: SEP-363856 75mg

Description: SEP-363856 75mg tablet dosed once daily

Arm group label: SEP-363856 75mg

Intervention type: Drug

Intervention name: SEP-363856 100mg

Description: SEP-363856 100mg tablet dosed once daily

Arm group label: SEP-363856 100mg

Intervention type: Drug

Intervention name: Placebo

Description: Placebo tablet dosed once daily

Arm group label: Placebo

Eligibility

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

Gender: All

Minimum age: 18 Years

Maximum age: 65 Years

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
CNS Medical Director Study Chair Sunovion
Overall Contact

Last name: CNS Medical Director

Phone: 1-866-503-6351

Email: [email protected]

Location
facility status contact
Woodland Research Northwest | Rogers, Arkansas, 72758, United States Recruiting Robert Billingsley, MD 479-927-3000
Collaborative Neuroscience Network | Long Beach, California, 90806, United States Recruiting David Walling, MD 714-799-7799
California Neuropsychopharmacology Clinical Research Institute | San Diego, California, 92102, United States Recruiting Christopher Benbow, MD 619-481-5252
Schuster Medical Research Institute | Sherman Oaks, California, 91403, United States Recruiting Jose Itzcovich-Schuster, MD 818-788-0746
Lake Charles Clinical Trials | Lake Charles, Louisiana, 70629, United States Recruiting Kashinath Yadalam, MD 337-564-6405
Hassman Research Institute | Marlton, New Jersey, 08053, United States Recruiting Howard Hassman, MD 856-452-9901
New York State Psychiatric Institute | New York, New York, 10032, United States Recruiting Jeffrey Lieberman, MD 646-774-5300
Pillar Clinical Research | Richardson, Texas, 75080, United States Recruiting Scott Bartley, MD 214-396-4844
Mental Health Centre, Prof. Dr. Ivan Temkov, Burgas EOOD, Department for Treatment of Emergency Psychiatric Conditions | Burgas, 8000, Bulgaria Recruiting Ivan Temkov, MD +359888451225
State Psychiatric Hospital - Kardzhali, First Woman Department, Third Men Deparment | Kardzhali, 6600, Bulgaria Recruiting Rozaliya Rangelova, MD +359889903682
State Psychiatric Hospital Sv. Ivan rilski-Department General Psychiatry for Adults "closed" Type -Men, Department General Psychiatry for Adults, "Closed" Type - Women | Novi Iskar, 1282, Bulgaria Recruiting Tsvetesiava Galabova, MD +3599917215
UMHAT Sveti Georgi EAD | Plovdiv, 4000, Bulgaria Active, not recruiting
LTD Psychoeurological Hospital of Daugavpils | Daugavpils, LV-5417, Latvia Recruiting Inna Sapele +37165402223
SLLC Riga Centre of Psychiatry and Narcology | Riga, LV-1005, Latvia Recruiting Elmars Rancans, Professor +37167080131
SLLC Psychoneurological Hospital of Strenci | Strenci, LV-4730, Latvia Recruiting Inga Bauska, MD +37164731340
State Public Institution of Healthcare Leningrad Regional Psychoneurological Dispensary | Leningrad, 188820, Russian Federation Recruiting Natalia Penchul, MD +78137864178
State Budgetary Institution of Healthcare of Moscow "Psychiatric Clinical Hospital #1 named after N.A. Alekseev of Department of Healthcare of Moscow | Moscow, 117152, Russian Federation Recruiting Anatoly Smulevich, MD +74959528331
State Budgetary Institution of Healthcare of Moscow "Psychiatric Hospital No. 5" | Moscow, 141371, Russian Federation Recruiting Alexander Arbuzov, MD +74965431346
Saint Petersburg State Budgetary Institution of Healthcare "Psychiatric Hospital named after P.P. Kashchenko, inpatient No 2 leg add | Saint Petersburg, 190005, Russian Federation Recruiting Liudmila Shapovalova, MD +79112700727
FSBI- "NMRC of Psychiatry and Neurology named after V.M. Bekhterev" MoH RF3 | Saint Petersburg, 192019, Russian Federation Recruiting Nikolay Nezanov, MD +78125675406
Saint Petersburg State Public Institution of Healthcare "City Psychiatric Hospital #3 named after I.I. Skvortsov-Stepanov" | Saint Petersburg, 197341, Russian Federation Recruiting Alexander Sofronov, MD +78123018654
Saint Petersburg State Public Institution of Healthcare "City Psychiatric Hospital #3 named after I.I. Skvortsov-Stepanov" | Saint Petersburg, 197341, Russian Federation Recruiting Alexander Sofronov, MD +79030951679
State Institution of Healthcare "Saratov City Clinical Hospital #2 named after V.I. Razumovskiy" 20 and 21 departments | Saratov, 410028, Russian Federation Recruiting Julia Barylnik, MD +79272266850
State Institution of Healthcare Regional Clinical Psychiatric Hospital of Saint Sofia | Saratov, 410060, Russian Federation Recruiting Irina Ivlieva +78452955048
FSBI "NMRC of Psychiatry and Neurology named after V.M. Bekterev" MoH RF | St. Petersburg, 192019, Russian Federation Recruiting Mikhail Ivanov, MD +79219306167
Clinic of Psychiatry, Clinical Center of Serbia | Belgrade, 11000, Serbia Recruiting Maja Ivkovic, PhD +38163252201
Special Neuropsychiatric Hospital Kovin | Kovin, 26220, Serbia Recruiting Snezana Djordjevic, MD +381641438246
Clinic of Psychiatry, clinical Center Kragujevac | Kragujevac, 34000, Serbia Recruiting Mirjana Jovanovic, Professor +38134370151
Special Hospital for Psychiatric Disease Sveti Vracevi | Novi Knezevac, 23330, Serbia Recruiting Jovan Milovanovic, MD +38163239962
46 Academician Pavlov St | Kharkiv, 61068, Ukraine Recruiting Viktor Kovalenko +380577381062
State Institution Institute of Neurology, Psychiatry and Narcology of the National Academy of Medical Sciences of Ukraine, Department of Boundary Psychiatry | Kharkiv, 61068, Ukraine Recruiting Nataliya Maruta +380677577772
Communica Noncommercial Enterprise Kherson Regional Institution of Psychiatric Care Assistance of Kherson Regional Council, Male Department of Psychiatry #3, Female Department of Psychiatry #10 | Kherson, 73488, Ukraine Recruiting Pavlo Palamarchuk, MD +38504940457
Kyev Clinical Hospital on Railway Station #1 of Healthcare Center branch of JSC "Ukrainian railway" Department of Psychoneurology | Kyiv, 01030, Ukraine Recruiting Oleg Chaban +380444651721
National Military and Medical Clinical Center, The Main Military Clinical Hospital, Psychiatric Clinic with Wards for Narcological Patients | Kyiv, 01133, Ukraine Recruiting Ievgeniia Grynevych +380996423313
Communal Institution of Kyiv Regional Council Regional Psychiatric and Narcological Medical Association, Male Department #10, Female Department #2 | Kyiv, 08631, Ukraine Recruiting Gennadii Ziberblat +380506480750
Communal Noncommercial Enterprise of Lviv Regional Concil Lviv Regional Clinical Psychiatric Hospital, Department #20 | Lviv, 79021, Ukraine Recruiting Kateryna Zakal +380677672919
Communal Institution O.I. Yuschenko Vinnytsia Regional Psychoneurological Hospital, Male Department #21, Female Department #15, M.I. Pyrogov Vinnytsia National Medical University, Chair of Psychiatry, Narcology and Psychotherapy with Postgraduate Educatio | Vinnytsia, 21005, Ukraine Recruiting Oksana Serebrennnikova, MD +380679605672
Location Countries

Bulgaria

Latvia

Russian Federation

Serbia

Ukraine

United States

Verification Date

May 2020

Responsible Party

Responsible party type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 3
Arm Group

Arm group label: SEP-363856 75mg

Arm group type: Experimental

Description: SEP-363856 75mg dosed once daily

Arm group label: SEP-363856 100mg

Arm group type: Experimental

Description: SEP-363856 100mg dosed once daily

Arm group label: Placebo

Arm group type: Placebo Comparator

Description: Placebo dosed once daily

Patient Data Yes
Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Intervention model description: A randomized, double-blind, parallel-group, placebo-controlled, fixed-dose, multicenter study

Primary purpose: Treatment

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking description: double-blind

Source: ClinicalTrials.gov