Phase
Condition
Tourette's Syndrome
Schizotypal Personality Disorder (Spd)
Mood Disorders
Treatment
SEP-363856 75mg
SEP-363856 50mg
Placebo
Clinical Study ID
Ages 13-65 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Male or female subject between 13 to 65 years of age (inclusive) at the time ofconsent.
Subject or subjects parent/legal guardian [adolescents] must give written informedconsent and privacy authorization prior to participate in the study; adolescentsmust also provide informed assent..
Subject meets DSM-5 criteria for schizophrenia as established by clinical interviewat screening
Subject must have a CGI-S score ≥ 4
Subject must have a PANSS total score ≥ 80 and a PANSS item score ≥ 4 on 2 or moreof the following PANSS items: delusions, conceptual disorganization, hallucinations,and unusual thought content
Subject has an acute exacerbation of psychotic symptoms (persisting no longer than 2months prior to providing informed consent).
Subject has marked deterioration of functioning in one or more areas.
Subject is, in the opinion of the Investigator, generally healthy based on screeningmedical history, PE, neurological examination, vital signs, ECG, and clinicallaboratory values.
Exclusion
Exclusion Criteria:
Subject has a DSM-5 diagnosis or presence of symptoms consistent with a DSM-5diagnosis other than schizophrenia. Exclusionary disorders include but are notlimited to alcohol use disorder (within past 12 months), substance (other thannicotine or caffeine) use disorder within past 12 months or lifetime history ofsignificant substance abuse that in the opinion of the Investigator or Sponsor, mayhave had a significant and potentially permanent impact of the brain or other bodysystems, major depressive disorder, bipolar I or II disorder, schizoaffectivedisorder, obsessive compulsive disorder, and posttraumatic stress disorder. Symptomsof mild to moderate mood dysphoria or anxiety are allowed so long as these symptomsare not the primary focus of treatment.
Subject is at significant risk of harming self, others, or objects based onInvestigator's judgment.
Subject has any clinically significant unstable medical condition or any clinicallysignificant chronic disease that in the opinion of the Investigator, would limit thesubject's ability to complete and/or participate in the study:
Female subject who is pregnant or lactating
Subject has any clinically significant abnormal laboratory value(s) at Screening asdetermined by the investigator.
Study Design
Study Description
Connect with a study center
State Psychiatric Hospital - Pazardzhik AD-Department of Active Treatment of Men Department for Active Treatment of Woman Department of Active Treatment of Mean and Woman
Pazardzhik, 4400
BulgariaSite Not Available
UMHAT-Dr. Georgi Stranski EAD-First Psychiatric clinic
Pleven, 5800
BulgariaSite Not Available
Mental Health Center-Sofia EOOD - Unit for Active Treatment of Persons with serious Mental Disorders
Sofia, 1202
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
First Department for Active Treatment - Men Second Department for Active Treatment - Men Women Department - Rehabilitation Sector Women Department - Acute Sector
Tsarev, 9747
BulgariaSite Not Available
Mental Health Center-Veliko Tarnovo EOOD-Deparmtentsof psychiatry for active treatment of persons with acute psychotic disorders
Veliko Tarnovo, 5000
BulgariaSite Not Available
Mental Health Center - Vratsa EOOD-Department of General Psychiatry
Vratsa, 3000
BulgariaSite Not Available
E.S.E Hospital Mental de Antioquia - Unidad de Investigación
Bello, Antioquia 051053
ColombiaSite Not Available
Centro de Investigaciones del Sistema Nervioso Limitada - Grupo CISNE Ltda
Bogota,
ColombiaSite Not Available
Centro de Investigaciones y Proyectos en Neurociencias CIPNA
Bogota,
ColombiaSite Not Available
Centro de Investigaciones del Sistema Nervioso Limitada - Grupo CISNE Ltda
Bogotá, 111166
ColombiaSite Not Available
State Budgetrary Institution of Healthcare Regional Clinical Specialized Psychiatric Hospital #1
Chelyabinsk, 454087
Russian FederationSite Not Available
State Budgetary Healthcare Institution of Republic Karelia "Republican Psyhiatric Hospital"
Karelia, 186131
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 nizhniy Novgorod region "Clinical Psychiatric Hosptial #1 of Nizhniy Novgorod
Nizniy Novgorod, 603155
Russian FederationSite Not Available
State Budgetary Healthcare Institution of Republic Karelia "Republican Psyhiatric Hospital"
Petrozavodsk, 186131
Russian FederationSite Not Available
FSBI 'NMRC of Psychiatry and Neurology named after V.M. Bekhterev MoH RF, department 12
Saint Petersburg, 192019
Russian FederationSite Not Available
State Budgetary Institution of Healthcare "Samara Regional Clinical Psychiatric Hospital"
Samara, 443016
Russian FederationSite Not Available
State Institution of Healthcare Saratov City Clninical Hospital #2, named after V.I. Razumovskiy psychiatric deparmtents
Saratov, 410028
Russian FederationSite Not Available
FSBI "NMRC of Psychiatry and Neurology named after V.M. Bekhterev" MoH RF, department 12
St. petersburg, 092019
Russian FederationSite Not Available
Clinical Center "Dr. Dragisa Misovic-Dedinje" Clinic of Psychiatry
Belgrade, 11000
SerbiaSite Not Available
Clinical Center Nis, Center of Mental Health Protection
Belgrade, 11000
SerbiaSite Not Available
Institute of Mental Health
Belgrade, 11000
SerbiaSite Not Available
Special Hospital for Psychiartric Diseases Gornja Toponica, Stevana, Sindjelica 39
Gornja Toponica, 18202
SerbiaSite Not Available
Special Hospital for Psychiatric Diseases "Kovin",
Kovin, 26220
SerbiaSite Not Available
Special Neuropsychiatric Hospital Kovin
Kovin, 26220
SerbiaSite Not Available
Clinical Center Kragujevac, Clinic of Psychiatry
Kragujevac, 34000
SerbiaSite Not Available
University Clinical Center Nis, Clinic of Psychiatry
Nis, 18000
SerbiaSite Not Available
Special Hospital for Psychiatric Diseases "SVeti Vracevi",
Novi Knezevac, 23330
SerbiaSite Not Available
Clinical Center of Vojvodina, Clinic of Psychiatry
Novi Sad, 21000
SerbiaSite Not Available
Special Hospital for Psychiatric Diseases
Vrsac, 26300
SerbiaSite Not Available
15, Medychna St
Ivano-Frankivsk, 76011
UkraineSite Not Available
2-A Metalurgiv st
Kropyvnytskyi, 25491
UkraineSite Not Available
103 Kyrylivska St
Kyiv, 04080
UkraineSite Not Available
Dr. Vladyslav Demchenko
Kyiv, 02192
UkraineSite Not Available
Communal Noncommercial Enterprise of Lviv Regional Council Lviv Regional Clinical Psychiatric Hospital, Department #25
Lviv, 79021
UkraineSite Not Available
1, Tsentraina Square, Oleksandrivka village, Lyman Region, Odesa Region
Odesa, 67513
UkraineSite Not Available
9 Academician Vorobiov St
Odesa, 65006
UkraineSite Not Available
1 Medychna St
Poltava, 36013
UkraineSite Not Available
Communal Non-commercial Enterprise Cherkasy Regional Psychiatric Hospital of Cherkasy Regional Council, Female Department #11, Male Department #12
Smila, 20708
UkraineSite Not Available
Comm. Institution O.I. Yushchenko Vinnytsia Reg. Psychoneurologoical Hospital
Vinnytsia, 21005
UkraineSite Not Available
Woodland International Research Group, LLC
Little Rock, Arkansas 72211
United StatesSite Not Available
Advanced Research Center, Inc.
Anaheim, California 92805
United StatesSite Not Available
CITrials
Bellflower, California 90706
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
Catalina Research Institute
Montclair, California 91763
United StatesSite Not Available
NRC Research Institute
Orange, California 92868
United StatesSite Not Available
California Neuropsychopharmacology Clinical Research Institute (CNRI-LA, LLC)
Pico Rivera, California 90660
United StatesSite Not Available
UCSD Medical Center,UCSD Department of Psychiatry
San Diego, California 92103-8229
United StatesSite Not Available
Larkin Behavioral Health Services
Hollywood, Florida 33021
United StatesSite Not Available
Research Centers of America
Hollywood, Florida 33024
United StatesSite Not Available
South Florida Research Phase I-IV, Inc.
Miami Springs, Florida 33166
United StatesSite Not Available
Advanced Discovery Research LLC
Atlanta, Georgia 30318
United StatesSite Not Available
Atlantic Center for Medical Research
Atlanta, Georgia 30331
United StatesSite Not Available
iResearch Atlanta, LLC
Decatur, Georgia 30030
United StatesSite Not Available
CBH Health, LLC
Gaithersburg, Maryland 20877
United StatesSite Not Available
Precise Research Centers
Flowood, Mississippi 39232
United StatesSite Not Available
Arch Clinical Trials, LLC
Saint Louis, Missouri 63125
United StatesSite Not Available
Clinical Research of Southern Nevada, LLC
Las Vegas, Nevada 89128
United StatesSite Not Available
Midwest Clinical Research Center
Dayton, Ohio 45417
United StatesSite Not Available
Community Clinical Research
Austin, Texas 78754
United StatesSite Not Available
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