Phase
Condition
Psychosis
Tourette's Syndrome
Mood Disorders
Treatment
SEP-363856
Clinical Study ID
Ages 13-65 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
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.
Participant has completed the Treatment Period of Study SEP361-301 or Study SEP361-302.
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.
Female participant must have a negative urine pregnancy test at the End of Treatment (EOT) Visit of Study SEP361-301 or Study SEP361-302.
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.
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
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.
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.
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
Female participant is pregnant or lactating.
Study Design
Study Description
Connect with a study center
Mental Health Centre Prof. Dr. Ivan Temkov - Burgas EOOD, Department for Treatment of Emergency Psychiatric Conditions
Burgas, 8000
BulgariaSite Not Available
Research Site
Burgas, 8000
BulgariaSite Not Available
Research Site
Kardzhali, 6600
BulgariaSite Not Available
State Psychiatric Hospital - Kardzhali, First Women Department, Third Men Department
Kardzhali, 6600
BulgariaSite Not Available
Research Site
Novi Iskar, 1282
BulgariaSite 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
BulgariaSite Not Available
Research Site
Pazardzhik, 4400
BulgariaSite 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
BulgariaSite Not Available
Research Site
Pleven, 5800
BulgariaSite Not Available
UMHAT-Dr. Georgi Stranski EAD, First Psychiatric Clinic
Pleven, 5800
BulgariaSite Not Available
Research Site
Sofia, 1431
BulgariaSite Not Available
UMHAT Alexandrovska EAD First Department of Psychiatry at Clinic of Psychiatry
Sofia, 1431
BulgariaSite Not Available
UMHAT Alexandrovska EAD Second Department of Pshychiatry at Clinic of Psychiatry
Sofia, 1431
BulgariaSite Not Available
Mental Health Center - Veliko Tarnovo EOOD-Department of psychiatry for active treatment of persons with acute psychiotic disorders
Veliko Tarnovo, 5000
BulgariaSite Not Available
Research Site
Veliko Tarnovo, 5000
BulgariaSite Not Available
Mental Health Center-Vratsa EOOD, Department of General Psychiatry
Vratsa, 3000
BulgariaSite Not Available
Research Site
Vratsa, 3000
BulgariaSite Not Available
Centro de Investigaciones y Proyectos en Neurociencias CIPNA
Barranquilla, 080020
ColombiaSite Not Available
Research Site
Barranquilla, 080020
ColombiaSite Not Available
Centro de Investigaciones del Sistema Nervioso Limitada - Grupo CISNE Ltda
Bogotá, 111166
ColombiaSite Not Available
Research Site
Bogotá, 111166
ColombiaSite Not Available
Psychiatric Hospital "Sveti Ivan"
Zagreb, 10090
CroatiaSite Not Available
Research Site
Zagreb, 10090
CroatiaSite Not Available
LTD Psychoneurological Hospital of Daugavpils
Daugavpils, LV-5417
LatviaSite Not Available
Research Site
Daugavpils, LV-5417
LatviaSite Not Available
Research Site
Riga, LV-1005
LatviaSite Not Available
SLLC Riga Centre of Psychiatry and Narcology
Riga, LV-1005
LatviaSite Not Available
Research Site
Strenci, LV-4730
LatviaSite Not Available
SLLC Psychoneurological Hospital of Strenci
Strenci, LV-4730
LatviaSite Not Available
Research Site
Chelyabinsk, 454087
Russian FederationSite Not Available
State Budgetary Institution of Healthcare "Regional Clinical Specialized Psychiatric Hospital #1"
Chelyabinsk, 454087
Russian FederationSite Not Available
Research Site
Leningrad, 188820
Russian FederationSite Not Available
State PUblic Institution of Healthcare Leningrad Regional Psychoneurological Dispensary
Leningrad, 188820
Russian FederationSite Not Available
Saint Petersburg State Budgetary Institution of Healthcare "Psychiatric Hospital n.a P.P. Kashchenko:
Mankovskay, 188357
Russian FederationSite Not Available
Research Site
Matrosy, 186131
Russian FederationSite Not Available
State Budgetary Institution of Healthcare of Karelia Republic "Republican Psychiatric Hospital" Mastrosy
Matrosy, 186131
Russian FederationSite 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 FederationSite Not Available
Institution of Healthcare Moscow "Psychiatric Clinical Hospital #1 Named after N.A. Alekseev of Department of Health Moscow"
Moscow, 117152
Russian FederationSite Not Available
Research Site
Moscow, 117152
Russian FederationSite Not Available
SBIH of Moscow "Psychiatric Clinical Hospital #4 n.a. P.B. Gannushkin"
Moscow, 107076
Russian FederationSite Not Available
State Budgetary institution of Healthcare of Moscow "Psychiatric Hospital №5
Moscow, 141371
Russian FederationSite Not Available
Research Site
Nizhniy Novgorod, 603155
Russian FederationSite Not Available
State Budgetary Institution of Healthcare of Nizhniy Novgorod region " Clinical Psychiatric Hospital # 1 of Nizhniy Novgorod
Nizhniy Novgorod, 603155
Russian FederationSite Not Available
State Budgetary Institution of Healthcare of Karelia Republic "Republican Psychiatric Hospital" Mastrosy
Republic Karelia, 186131
Russian FederationSite Not Available
State Budgetary Institution of Healthcare of Karelia Republic "Republican Psychiatric Hospital" Mastrosy
Republic Of Karelia, 186131
Russian FederationSite 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 FederationSite 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 FederationSite 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 FederationSite Not Available
Research Site
Saint Petersburg, 197341
Russian FederationSite Not Available
Saint Petersburg State Budgetary Institution of Healthcare "Psychiatric Hospital n.a P.P. Kashchenko:
Saint Petersburg, 188357
Russian FederationSite 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 FederationSite Not Available
Saint Petersburg State Public Institution of Healthcare "City Psychiatric Hospital #3 named after I.I. Skvortson"
Saint Petersburg, 197341
Russian FederationSite Not Available
Research Site
Samara, 443016
Russian FederationSite Not Available
State Budgetary Institution of Healthcrae "Samara Regional Clinical Psychiatric Hospital"
Samara, 443016
Russian FederationSite Not Available
Research Site
Saratov, 413124
Russian FederationSite Not Available
State Institution of Healthcare "Engels Psychiatric Hospital" Ministry of Healthcare of Saratov region
Saratov, 413124
Russian FederationSite Not Available
State Institution of Healthcare "Regional Clinical Psychiatric Hospital of Saint Sofia"
Saratov, 410060
Russian FederationSite Not Available
State Institution of Healthcare "Saratov City Clinical Hospital # 2 named after V.I. Razumovskiy" 20 and 21 department
Saratov, 410028
Russian FederationSite Not Available
State Institution of Healthcare "Saratov City Clinical Hospital #2 named after V.I. Razumovskiy", psychiatric departments
Saratov, 410028
Russian FederationSite 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 FederationSite Not Available
Research Site
St. Petersburg, 192019
Russian FederationSite Not Available
Research Site
Stavropol, 357034
Russian FederationSite Not Available
State Budgetary Healthcare Institution of Stavropol region "Stavropol Region Psychiatric Hospital # 2",
Stavropol, 357034
Russian FederationSite Not Available
Research Site
Talagi, 163530
Russian FederationSite Not Available
State Budgetary Healthcare Institution of Arkhangelsk region "Arkhangelsk clinical psychiatric hospital"
Talagi, 163530
Russian FederationSite Not Available
Clinic of Psychiatry, Clinical Center of Serbia
Belgrade, 11000
SerbiaSite Not Available
Clinical Center "Dr. Dragisa Misovic-Dedinje" Clinic of Psychiatry
Belgrade, 11000
SerbiaSite Not Available
Institute of Mental Health
Belgrade, 11000
SerbiaSite Not Available
Research Site
Belgrade, 11000
SerbiaSite Not Available
Research Site
Gornja Toponica, 18202
SerbiaSite Not Available
Special Hospital for Psychiatric Diseases Gornja Toponica
Gornja Toponica, 18202
SerbiaSite Not Available
Research Site
Kovin, 26220
SerbiaSite Not Available
Special Neuropsychiatric Hospital Kovin
Kovin, 26220
SerbiaSite Not Available
Clinic of Psychiatry, Clinical Center Kragujevac
Kragujevac, 34000
SerbiaSite Not Available
Clinical Center Kragujevac, Clinic of Psychiatry
Kragujevac, 34000
SerbiaSite Not Available
Research Site
Kragujevac, 34000
SerbiaSite Not Available
Research Site
Nis, 18000
SerbiaSite Not Available
University Clinical Center Nis, Clinic of Psychiatry
Nis, 18000
SerbiaSite Not Available
Research Site
Novi Knezevac, 23330
SerbiaSite Not Available
Special Hospital for Psychiatric Diseases Sveti Vracevi, Kralja Petra I
Novi Knezevac, 23330
SerbiaSite Not Available
Clinical Center of Vojvodina, Clinic of Psychiatry
Novi Sad, 21000
SerbiaSite Not Available
Research Site
Novi Sad, 21000
SerbiaSite Not Available
Research Site
Vrsac, 26300
SerbiaSite Not Available
Special Hospital for Psychiatric Diseases "Dr Slavoljub Bakalovic"
Vrsac, 26300
SerbiaSite 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
UkraineSite Not Available
Research Site
Ivano-Frankivsk, 76011
UkraineSite Not Available
Commercial Non-Commercial Enterprise of Kharkiv Regional Council Psychiatric Department of Primary Psychotic Episode
Kharkiv, 61068
UkraineSite Not Available
Research Site
Kharkiv, 61068
UkraineSite 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
UkraineSite 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
UkraineSite Not Available
Research Site
Kherson, 73488
UkraineSite Not Available
2-A Metalurgiv street
Kirovograd, 25491
UkraineSite Not Available
Communal Institution of Kyiv Regional Council Regional Psychiatric and Narcological Medical Association, Male Department #10, Female Department #2
Kyiv, 08631
UkraineSite Not Available
Kyiv City Psychoneurological Hospital #2
Kyiv, 02192
UkraineSite Not Available
Kyiv Clinical Hospital on Railway Station #1 of Healthcare Center branch of JSC "Ukrainian Railway", Department of Psychoneurology
Kyiv, 01030
UkraineSite Not Available
National Military and Medical Clinical Center, The Main Military Clinical Hospital, Psychiatric Clinic with Wards for Narcological Patients
Kyiv, 01133
UkraineSite Not Available
Research Site
Kyiv, 04080
UkraineSite 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
UkraineSite Not Available
Communal Noncommercial Enterprise of Lviv Regional Council Lviv Regional clinical Psychiatric Hospital, Department #20
Lviv, 79021
UkraineSite Not Available
Communial Noncommercial Enterprise of Lviv Regional Council Lviv Regional Clinical Psychiatric Hospital, Department #25
Lviv, 79021
UkraineSite Not Available
Research Site
Lviv, 79021
UkraineSite Not Available
2-A Metalurgiv street
Nove, 25491
UkraineSite Not Available
Research Site
Nove, 25491
UkraineSite Not Available
Communal Institution Odesa Regional Psychiatric Hospital #2, Department #14 (female), Department #16 (male)
Odesa, 67513
UkraineSite 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
UkraineSite Not Available
Research Site
Odesa, 67513
UkraineSite 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
UkraineSite 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
UkraineSite Not Available
Research Site
Vinnytsia, 21005
UkraineSite Not Available
Research Site
Little Rock, Arkansas 72211
United StatesSite Not Available
Woodland International Research Group, LLC
Little Rock, Arkansas 72211
United StatesSite Not Available
Research Site
Rogers, Arkansas 72758
United StatesSite Not Available
Woodland Research Northwest
Rogers, Arkansas 72758
United StatesSite Not Available
Advanced Research Center, Inc.
Anaheim, California 92805
United StatesSite Not Available
Research Site
Anaheim, California 92805
United StatesSite Not Available
ProScience Research Group
Culver City, California 90230
United StatesSite Not Available
Research Site
Culver City, California 90230
United StatesSite Not Available
Research Site
Lemon Grove, California 91945
United StatesSite Not Available
Synergy San Diego
Lemon Grove, California 91945
United StatesSite Not Available
Alliance for Research
Long Beach, California 90807
United StatesSite Not Available
Collaborative Neuroscience Network
Long Beach, California 90806
United StatesSite Not Available
Research Site
Long Beach, California 90806
United StatesSite Not Available
Catalina Research Institute
Montclair, California 91763
United StatesSite Not Available
Research Site
Montclair, California 91763
United StatesSite Not Available
California Neuropsychopharmacology Clinical research Institute (CNRI-LA, LLC)
San Diego, California 92102
United StatesSite Not Available
California Neuropsychopharmacology clinical Research Institute
San Diego, California 92102
United StatesSite Not Available
Research Site
San Diego, California 92102
United StatesSite Not Available
Research Site
Sherman Oaks, California 91403
United StatesSite Not Available
Schuster Medical Research Institute
Sherman Oaks, California 91403
United StatesSite Not Available
Research Site
Miami Springs, Florida 33166
United StatesSite Not Available
South Florida Research Phase I-IV, Inc.
Miami Springs, Florida 33166
United StatesSite Not Available
Fort Lauderdale Behavioral Health Center
Oakland Park, Florida 33334
United StatesSite Not Available
Research Site
Oakland Park, Florida 33334
United StatesSite Not Available
Advanced Discovery Research LLC
Atlanta, Georgia 30318
United StatesSite Not Available
Atlanta Center for Medical Research
Atlanta, Georgia 30331
United StatesSite Not Available
Research Site
Atlanta, Georgia 30331
United StatesSite Not Available
iResearch Atlanta, LLC
Atlanta, Georgia 30030
United StatesSite Not Available
Research Site
Decatur, Georgia 30030
United StatesSite Not Available
iResearch Atlanta, LLC
Decatur, Georgia 30030
United StatesSite Not Available
Lake Charles Clinical Trials
Lake Charles, Louisiana 70629
United StatesSite Not Available
Research Site
Lake Charles, Louisiana 70629
United StatesSite Not Available
CBH Health, LLC
Gaithersburg, Maryland 20877
United StatesSite Not Available
Research Site
Gaithersburg, Maryland 20877
United StatesSite Not Available
Precise Research Centers
Flowood, Mississippi 39232
United StatesSite Not Available
Research Site
Flowood, Mississippi 39232
United StatesSite Not Available
Arch Clinical Trials, LLC
Saint Louis, Missouri 63125
United StatesSite Not Available
Research Site
Saint Louis, Missouri 63125
United StatesSite Not Available
Hassman Research Institute
Marlton, New Jersey 08053
United StatesSite Not Available
Research Site
Marlton, New Jersey 08053
United StatesSite Not Available
New York State Psychiatric Institute
New York, New York 10032
United StatesSite Not Available
Research Site
New York, New York 10032
United StatesSite Not Available
Midwest Clinical research Center
Dayton, Ohio 45417
United StatesSite Not Available
Research Site
Dayton, Ohio 45417
United StatesSite Not Available
Dr. David Brown, Community Clinical Research
Austin, Texas 78754
United StatesSite Not Available
Research Site
Austin, Texas 78754
United StatesSite Not Available
Pillar Clinical Research
Richardson, Texas 75080
United StatesSite Not Available
Research Site
Richardson, Texas 75080
United StatesSite Not Available
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