A Clinical Study to Evaluate the Long-term Safety and Tolerability of an Investigational Drug in People With Schizophrenia

Last updated: December 12, 2024
Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Overall Status: Terminated

Phase

3

Condition

Psychosis

Tourette's Syndrome

Mood Disorders

Treatment

SEP-363856

Clinical Study ID

NCT04109950
SEP361-303
2019-000696-16
  • Ages 13-65
  • All Genders

Study Summary

This is a clinical trial to determine the long-term safety and tolerability of an investigational drug in people with schizophrenia. Participants in the study will receive the drug being studied. This study is accepting male and female participants between 13 and 65 years old who have been diagnosed with schizophrenia and have completed Study SEP361-301 (NCT04072354) or Study SEP361-302 (NCT04092686). This study will be conducted in approximately 80 study centers worldwide. The treatment duration for this study is one (1) year.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Participant (or participants parent/legal guardian for adolescents) must give written informed consent and privacy authorization prior to participation in the study; adolescents must also provide informed assent.

  2. Participant has completed the Treatment Period of Study SEP361-301 or Study SEP361-302.

  3. Participant has not taken any medication other than the study drug and protocol-allowed medications for the purpose of controlling schizophrenia symptoms during Study SEP361-301 or SEP361-302.

  4. Female participant must have a negative urine pregnancy test at the End of Treatment (EOT) Visit of Study SEP361-301 or Study SEP361-302.

  5. Female participants of childbearing potential must agree to use highly effective and reliable contraception throughout the study and for at least 30 days after the last dose of study drug has been taken.

  6. Male participants must agree to avoid fathering a child and use highly effective methods of birth control from screening in Study SEP361-301 or Study SEP361-302, until at least 30 days after the last study drug administration in the present study (SEP361-303).

Exclusion Criteria

  1. Participant answered "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 Columbia Suicide Severity Rating Scale (C-SSRS) assessment at the End of treatment (EO) Visit of Study SEP361-301 or SEP361-302.

  2. Participant has a clinically significant abnormality including physical examination, vital signs, ECG, or laboratory test at the EOT Visit of Study SEP361-301 or SEP361-302 that the investigator in consultation with the medical monitor considers to be inappropriate to allow participation in the study.

  3. Participant has a positive urine drug screen (UDS) at the EOT Visit of Study SEP361-301 or SEP361-302. However, a positive UDS test may not result in exclusion of participants if the Investigator determines that the positive test is as a result of prescription medicine(s). participants may enter this study before the urine drug screen results are received from the central laboratory. However, after receipt and review of the results any participant meeting this exclusion criterion must be discontinued from the study. Retesting of the UDS is allowed once with prior approval from the Medical Monitor with the retest used to determine eligibility

  4. Female participant is pregnant or lactating.

Study Design

Total Participants: 463
Treatment Group(s): 1
Primary Treatment: SEP-363856
Phase: 3
Study Start date:
November 20, 2019
Estimated Completion Date:
November 09, 2023

Study Description

An open-label extension study to assess the safety and tolerability of SEP-363856 in participants with schizophrenia This is an open-label extension study to evaluate long-term safety and tolerability of SEP-363856. This is a 52-week, outpatient, multicenter, flexible-dose, open-label extension study designed to evaluate the long-term safety and tolerability of SEP-363856 (25 to 100 mg/day) for the treatment of participants with schizophrenia who have completed the Treatment Period of one of the two following double-blind studies: Study SEP361-301 (NCT04072354) or Study SEP361-302 (NCT04092686).

Sumitomo Pharma America Inc. was the former Sponsor and conducted this study. Sumitomo was responsible for analysis and clinical study report (CSR) completion. Otsuka took over study after IND was transferred and is concluding activities with registry postings.

Connect with a study center

  • Mental Health Centre Prof. Dr. Ivan Temkov - Burgas EOOD, Department for Treatment of Emergency Psychiatric Conditions

    Burgas, 8000
    Bulgaria

    Site Not Available

  • Research Site

    Burgas, 8000
    Bulgaria

    Site Not Available

  • Research Site

    Kardzhali, 6600
    Bulgaria

    Site Not Available

  • State Psychiatric Hospital - Kardzhali, First Women Department, Third Men Department

    Kardzhali, 6600
    Bulgaria

    Site Not Available

  • Research Site

    Novi Iskar, 1282
    Bulgaria

    Site Not Available

  • 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

    Site Not Available

  • Research Site

    Pazardzhik, 4400
    Bulgaria

    Site Not Available

  • State Psychiatric Hospital-Pazardzhik AD, Department for Active Treatment of Men Department for Active Treatment of Women , Department of Active Treatment of Men and Women

    Pazardzhik, 4400
    Bulgaria

    Site Not Available

  • Research Site

    Pleven, 5800
    Bulgaria

    Site Not Available

  • UMHAT-Dr. Georgi Stranski EAD, First Psychiatric Clinic

    Pleven, 5800
    Bulgaria

    Site Not Available

  • Research Site

    Sofia, 1431
    Bulgaria

    Site Not Available

  • UMHAT Alexandrovska EAD First Department of Psychiatry at Clinic of Psychiatry

    Sofia, 1431
    Bulgaria

    Site Not Available

  • UMHAT Alexandrovska EAD Second Department of Pshychiatry at Clinic of Psychiatry

    Sofia, 1431
    Bulgaria

    Site Not Available

  • Mental Health Center - Veliko Tarnovo EOOD-Department of psychiatry for active treatment of persons with acute psychiotic disorders

    Veliko Tarnovo, 5000
    Bulgaria

    Site Not Available

  • Research Site

    Veliko Tarnovo, 5000
    Bulgaria

    Site Not Available

  • Mental Health Center-Vratsa EOOD, Department of General Psychiatry

    Vratsa, 3000
    Bulgaria

    Site Not Available

  • Research Site

    Vratsa, 3000
    Bulgaria

    Site Not Available

  • Centro de Investigaciones y Proyectos en Neurociencias CIPNA

    Barranquilla, 080020
    Colombia

    Site Not Available

  • Research Site

    Barranquilla, 080020
    Colombia

    Site Not Available

  • Centro de Investigaciones del Sistema Nervioso Limitada - Grupo CISNE Ltda

    Bogotá, 111166
    Colombia

    Site Not Available

  • Research Site

    Bogotá, 111166
    Colombia

    Site Not Available

  • Psychiatric Hospital "Sveti Ivan"

    Zagreb, 10090
    Croatia

    Site Not Available

  • Research Site

    Zagreb, 10090
    Croatia

    Site Not Available

  • LTD Psychoneurological Hospital of Daugavpils

    Daugavpils, LV-5417
    Latvia

    Site Not Available

  • Research Site

    Daugavpils, LV-5417
    Latvia

    Site Not Available

  • Research Site

    Riga, LV-1005
    Latvia

    Site Not Available

  • SLLC Riga Centre of Psychiatry and Narcology

    Riga, LV-1005
    Latvia

    Site Not Available

  • Research Site

    Strenci, LV-4730
    Latvia

    Site Not Available

  • SLLC Psychoneurological Hospital of Strenci

    Strenci, LV-4730
    Latvia

    Site Not Available

  • Research Site

    Chelyabinsk, 454087
    Russian Federation

    Site Not Available

  • State Budgetary Institution of Healthcare "Regional Clinical Specialized Psychiatric Hospital #1"

    Chelyabinsk, 454087
    Russian Federation

    Site Not Available

  • Research Site

    Leningrad, 188820
    Russian Federation

    Site Not Available

  • State PUblic Institution of Healthcare Leningrad Regional Psychoneurological Dispensary

    Leningrad, 188820
    Russian Federation

    Site Not Available

  • Saint Petersburg State Budgetary Institution of Healthcare "Psychiatric Hospital n.a P.P. Kashchenko:

    Mankovskay, 188357
    Russian Federation

    Site Not Available

  • Research Site

    Matrosy, 186131
    Russian Federation

    Site Not Available

  • State Budgetary Institution of Healthcare of Karelia Republic "Republican Psychiatric Hospital" Mastrosy

    Matrosy, 186131
    Russian Federation

    Site Not Available

  • Saint Petersburg State Budgetary Institution of Healthcare "Psychiatric Hosptial named after P.P. Kashchenko, inpatient no 2 legg add: 10

    Menkovskay, 190005
    Russian Federation

    Site Not Available

  • Institution of Healthcare Moscow "Psychiatric Clinical Hospital #1 Named after N.A. Alekseev of Department of Health Moscow"

    Moscow, 117152
    Russian Federation

    Site Not Available

  • Research Site

    Moscow, 117152
    Russian Federation

    Site Not Available

  • SBIH of Moscow "Psychiatric Clinical Hospital #4 n.a. P.B. Gannushkin"

    Moscow, 107076
    Russian Federation

    Site Not Available

  • State Budgetary institution of Healthcare of Moscow "Psychiatric Hospital №5

    Moscow, 141371
    Russian Federation

    Site Not Available

  • Research Site

    Nizhniy Novgorod, 603155
    Russian Federation

    Site Not Available

  • State Budgetary Institution of Healthcare of Nizhniy Novgorod region " Clinical Psychiatric Hospital # 1 of Nizhniy Novgorod

    Nizhniy Novgorod, 603155
    Russian Federation

    Site Not Available

  • State Budgetary Institution of Healthcare of Karelia Republic "Republican Psychiatric Hospital" Mastrosy

    Republic Karelia, 186131
    Russian Federation

    Site Not Available

  • State Budgetary Institution of Healthcare of Karelia Republic "Republican Psychiatric Hospital" Mastrosy

    Republic Of Karelia, 186131
    Russian Federation

    Site Not Available

  • FSBI "NMRC of Psychiatry and Neurology n.a. V.M. Bekhterev" MoH RF 3, Bekhtereva str, Saint Petersbur, 192019, Russia based on SPb SI of Healthcare "City Psychiatric Hospital #6"

    Saint Petersburg, 191167
    Russian Federation

    Site Not Available

  • Federal State Budgetary Institution "National Medical Research Center o Psychiatry and Neurology named after V.M. Bekhterev" of the Ministry of Healthcare of the Russian Fereration

    Saint Petersburg, 192019
    Russian Federation

    Site Not Available

  • Federal State Budgetary Institution "National Medical Research Center of Psychiatry and Neurology n. a. V. M. Bekhterev" of the Ministry of Healthcare of the Russian Federation

    Saint Petersburg, 192019
    Russian Federation

    Site Not Available

  • Research Site

    Saint Petersburg, 197341
    Russian Federation

    Site Not Available

  • Saint Petersburg State Budgetary Institution of Healthcare "Psychiatric Hospital n.a P.P. Kashchenko:

    Saint Petersburg, 188357
    Russian Federation

    Site Not Available

  • Saint Petersburg State Budgetary Institution of Healthcare "Psychiatric Hosptial named after P.P. Kashchenko, inpatient no 2 legg add: 10

    Saint Petersburg, 190005
    Russian Federation

    Site Not Available

  • Saint Petersburg State Public Institution of Healthcare "City Psychiatric Hospital #3 named after I.I. Skvortson"

    Saint Petersburg, 197341
    Russian Federation

    Site Not Available

  • Research Site

    Samara, 443016
    Russian Federation

    Site Not Available

  • State Budgetary Institution of Healthcrae "Samara Regional Clinical Psychiatric Hospital"

    Samara, 443016
    Russian Federation

    Site Not Available

  • Research Site

    Saratov, 413124
    Russian Federation

    Site Not Available

  • State Institution of Healthcare "Engels Psychiatric Hospital" Ministry of Healthcare of Saratov region

    Saratov, 413124
    Russian Federation

    Site Not Available

  • State Institution of Healthcare "Regional Clinical Psychiatric Hospital of Saint Sofia"

    Saratov, 410060
    Russian Federation

    Site Not Available

  • State Institution of Healthcare "Saratov City Clinical Hospital # 2 named after V.I. Razumovskiy" 20 and 21 department

    Saratov, 410028
    Russian Federation

    Site Not Available

  • State Institution of Healthcare "Saratov City Clinical Hospital #2 named after V.I. Razumovskiy", psychiatric departments

    Saratov, 410028
    Russian Federation

    Site Not Available

  • Federal State Budgetary Institution "National Medical Research Center of Psychiatry and Neurology named after V. M. Bekhterev" of the Ministry of the Healthcare of Russian federation

    St. Petersburg, 192019
    Russian Federation

    Site Not Available

  • Research Site

    St. Petersburg, 192019
    Russian Federation

    Site Not Available

  • Research Site

    Stavropol, 357034
    Russian Federation

    Site Not Available

  • State Budgetary Healthcare Institution of Stavropol region "Stavropol Region Psychiatric Hospital # 2",

    Stavropol, 357034
    Russian Federation

    Site Not Available

  • Research Site

    Talagi, 163530
    Russian Federation

    Site Not Available

  • State Budgetary Healthcare Institution of Arkhangelsk region "Arkhangelsk clinical psychiatric hospital"

    Talagi, 163530
    Russian Federation

    Site Not Available

  • Clinic of Psychiatry, Clinical Center of Serbia

    Belgrade, 11000
    Serbia

    Site Not Available

  • Clinical Center "Dr. Dragisa Misovic-Dedinje" Clinic of Psychiatry

    Belgrade, 11000
    Serbia

    Site Not Available

  • Institute of Mental Health

    Belgrade, 11000
    Serbia

    Site Not Available

  • Research Site

    Belgrade, 11000
    Serbia

    Site Not Available

  • Research Site

    Gornja Toponica, 18202
    Serbia

    Site Not Available

  • Special Hospital for Psychiatric Diseases Gornja Toponica

    Gornja Toponica, 18202
    Serbia

    Site Not Available

  • Research Site

    Kovin, 26220
    Serbia

    Site Not Available

  • Special Neuropsychiatric Hospital Kovin

    Kovin, 26220
    Serbia

    Site Not Available

  • Clinic of Psychiatry, Clinical Center Kragujevac

    Kragujevac, 34000
    Serbia

    Site Not Available

  • Clinical Center Kragujevac, Clinic of Psychiatry

    Kragujevac, 34000
    Serbia

    Site Not Available

  • Research Site

    Kragujevac, 34000
    Serbia

    Site Not Available

  • Research Site

    Nis, 18000
    Serbia

    Site Not Available

  • University Clinical Center Nis, Clinic of Psychiatry

    Nis, 18000
    Serbia

    Site Not Available

  • Research Site

    Novi Knezevac, 23330
    Serbia

    Site Not Available

  • Special Hospital for Psychiatric Diseases Sveti Vracevi, Kralja Petra I

    Novi Knezevac, 23330
    Serbia

    Site Not Available

  • Clinical Center of Vojvodina, Clinic of Psychiatry

    Novi Sad, 21000
    Serbia

    Site Not Available

  • Research Site

    Novi Sad, 21000
    Serbia

    Site Not Available

  • Research Site

    Vrsac, 26300
    Serbia

    Site Not Available

  • Special Hospital for Psychiatric Diseases "Dr Slavoljub Bakalovic"

    Vrsac, 26300
    Serbia

    Site Not Available

  • Regional Psychoneurological Hospital#3, Department of Critical Conditions and Primary Psychotic Episode for Adult Population #1, Ivano-Frankivsk National Medical University, Chair of Psychiatry, Narcology and Medical Pschology

    Ivano-Frankivsk, 76011
    Ukraine

    Site Not Available

  • Research Site

    Ivano-Frankivsk, 76011
    Ukraine

    Site Not Available

  • Commercial Non-Commercial Enterprise of Kharkiv Regional Council Psychiatric Department of Primary Psychotic Episode

    Kharkiv, 61068
    Ukraine

    Site Not Available

  • Research Site

    Kharkiv, 61068
    Ukraine

    Site Not Available

  • State Institution Institute of Neurology, Psychiatry and Narcology of the National Academy of Medical Sciences of Ukraine, Department of Boundary Psychiatry

    Kharkiv, 61068
    Ukraine

    Site Not Available

  • Communal 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

    Site Not Available

  • Research Site

    Kherson, 73488
    Ukraine

    Site Not Available

  • 2-A Metalurgiv street

    Kirovograd, 25491
    Ukraine

    Site Not Available

  • Communal Institution of Kyiv Regional Council Regional Psychiatric and Narcological Medical Association, Male Department #10, Female Department #2

    Kyiv, 08631
    Ukraine

    Site Not Available

  • Kyiv City Psychoneurological Hospital #2

    Kyiv, 02192
    Ukraine

    Site Not Available

  • Kyiv Clinical Hospital on Railway Station #1 of Healthcare Center branch of JSC "Ukrainian Railway", Department of Psychoneurology

    Kyiv, 01030
    Ukraine

    Site Not Available

  • National Military and Medical Clinical Center, The Main Military Clinical Hospital, Psychiatric Clinic with Wards for Narcological Patients

    Kyiv, 01133
    Ukraine

    Site Not Available

  • Research Site

    Kyiv, 04080
    Ukraine

    Site Not Available

  • Territorial Medical Association Psychiatry in Kyiv, Center of Novel Methods of Treatment and Rehabilitation of Psychotic Conditions, Department #29 (male), Department #30 (female), Outpatient and Polyclinic Office at Department #30

    Kyiv, 04080
    Ukraine

    Site Not Available

  • Communal Noncommercial Enterprise of Lviv Regional Council Lviv Regional clinical Psychiatric Hospital, Department #20

    Lviv, 79021
    Ukraine

    Site Not Available

  • Communial Noncommercial Enterprise of Lviv Regional Council Lviv Regional Clinical Psychiatric Hospital, Department #25

    Lviv, 79021
    Ukraine

    Site Not Available

  • Research Site

    Lviv, 79021
    Ukraine

    Site Not Available

  • 2-A Metalurgiv street

    Nove, 25491
    Ukraine

    Site Not Available

  • Research Site

    Nove, 25491
    Ukraine

    Site Not Available

  • Communal Institution Odesa Regional Psychiatric Hospital #2, Department #14 (female), Department #16 (male)

    Odesa, 67513
    Ukraine

    Site Not Available

  • Communal Non-commercial Enterprise Odesa Regional Medical Center of Mental Health of Odesa Regional Council, Department #6 (male), Department #12 (female)

    Odesa, 65006
    Ukraine

    Site Not Available

  • Research Site

    Odesa, 67513
    Ukraine

    Site Not Available

  • Communal Institution O.I. Yushchenko Vinnytsia Regional Psychoneurological Hospital, Female Department #10, Male Department #7, Vinnytsia M.I.Pyrogov National Medical University, Chair of Psychiatry, Narcology and Psychotherapy with Postgraduate Education

    Vinnytsia, 21005
    Ukraine

    Site Not Available

  • Communal Institution O.I.Yushchenko 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

    Site Not Available

  • Research Site

    Vinnytsia, 21005
    Ukraine

    Site Not Available

  • Research Site

    Little Rock, Arkansas 72211
    United States

    Site Not Available

  • Woodland International Research Group, LLC

    Little Rock, Arkansas 72211
    United States

    Site Not Available

  • Research Site

    Rogers, Arkansas 72758
    United States

    Site Not Available

  • Woodland Research Northwest

    Rogers, Arkansas 72758
    United States

    Site Not Available

  • Advanced Research Center, Inc.

    Anaheim, California 92805
    United States

    Site Not Available

  • Research Site

    Anaheim, California 92805
    United States

    Site Not Available

  • ProScience Research Group

    Culver City, California 90230
    United States

    Site Not Available

  • Research Site

    Culver City, California 90230
    United States

    Site Not Available

  • Research Site

    Lemon Grove, California 91945
    United States

    Site Not Available

  • Synergy San Diego

    Lemon Grove, California 91945
    United States

    Site Not Available

  • Alliance for Research

    Long Beach, California 90807
    United States

    Site Not Available

  • Collaborative Neuroscience Network

    Long Beach, California 90806
    United States

    Site Not Available

  • Research Site

    Long Beach, California 90806
    United States

    Site Not Available

  • Catalina Research Institute

    Montclair, California 91763
    United States

    Site Not Available

  • Research Site

    Montclair, California 91763
    United States

    Site Not Available

  • California Neuropsychopharmacology Clinical research Institute (CNRI-LA, LLC)

    San Diego, California 92102
    United States

    Site Not Available

  • California Neuropsychopharmacology clinical Research Institute

    San Diego, California 92102
    United States

    Site Not Available

  • Research Site

    San Diego, California 92102
    United States

    Site Not Available

  • Research Site

    Sherman Oaks, California 91403
    United States

    Site Not Available

  • Schuster Medical Research Institute

    Sherman Oaks, California 91403
    United States

    Site Not Available

  • Research Site

    Miami Springs, Florida 33166
    United States

    Site Not Available

  • South Florida Research Phase I-IV, Inc.

    Miami Springs, Florida 33166
    United States

    Site Not Available

  • Fort Lauderdale Behavioral Health Center

    Oakland Park, Florida 33334
    United States

    Site Not Available

  • Research Site

    Oakland Park, Florida 33334
    United States

    Site Not Available

  • Advanced Discovery Research LLC

    Atlanta, Georgia 30318
    United States

    Site Not Available

  • Atlanta Center for Medical Research

    Atlanta, Georgia 30331
    United States

    Site Not Available

  • Research Site

    Atlanta, Georgia 30331
    United States

    Site Not Available

  • iResearch Atlanta, LLC

    Atlanta, Georgia 30030
    United States

    Site Not Available

  • Research Site

    Decatur, Georgia 30030
    United States

    Site Not Available

  • iResearch Atlanta, LLC

    Decatur, Georgia 30030
    United States

    Site Not Available

  • Lake Charles Clinical Trials

    Lake Charles, Louisiana 70629
    United States

    Site Not Available

  • Research Site

    Lake Charles, Louisiana 70629
    United States

    Site Not Available

  • CBH Health, LLC

    Gaithersburg, Maryland 20877
    United States

    Site Not Available

  • Research Site

    Gaithersburg, Maryland 20877
    United States

    Site Not Available

  • Precise Research Centers

    Flowood, Mississippi 39232
    United States

    Site Not Available

  • Research Site

    Flowood, Mississippi 39232
    United States

    Site Not Available

  • Arch Clinical Trials, LLC

    Saint Louis, Missouri 63125
    United States

    Site Not Available

  • Research Site

    Saint Louis, Missouri 63125
    United States

    Site Not Available

  • Hassman Research Institute

    Marlton, New Jersey 08053
    United States

    Site Not Available

  • Research Site

    Marlton, New Jersey 08053
    United States

    Site Not Available

  • New York State Psychiatric Institute

    New York, New York 10032
    United States

    Site Not Available

  • Research Site

    New York, New York 10032
    United States

    Site Not Available

  • Midwest Clinical research Center

    Dayton, Ohio 45417
    United States

    Site Not Available

  • Research Site

    Dayton, Ohio 45417
    United States

    Site Not Available

  • Dr. David Brown, Community Clinical Research

    Austin, Texas 78754
    United States

    Site Not Available

  • Research Site

    Austin, Texas 78754
    United States

    Site Not Available

  • Pillar Clinical Research

    Richardson, Texas 75080
    United States

    Site Not Available

  • Research Site

    Richardson, Texas 75080
    United States

    Site Not Available

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