Phase
Condition
Mood Disorders
Tourette's Syndrome
Schizotypal Personality Disorder (Spd)
Treatment
Placebo
PP1M
PP3M 350 mg eq.
Clinical Study ID
Ages 18-70 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Must meet the diagnostic criteria for schizophrenia according to Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM 5) for at least 6 months before screening
Must be receiving treatment with paliperidone palmitate (as either the paliperidone palmitate 1-month (PP1M) or paliperidone palmitate 3-month (PP3M) formulation), or injectable risperidone, or any oral antipsychotic
Must be able, in the opinion of the investigator, to discontinue any antipsychotic medication other than PP1M) or PP3M during the Screening Phase
Must have a full Positive and Negative Syndrome Scale (PANSS) score of less than (<) 70 points at screening
Must have a body mass index (BMI) between 17 and 40 kilogram (kg)/meter (m)^2 (inclusive) and must have a body weight of at least 47 kg at screening
Must be willing to receive gluteal injections of medication during the Double-blind Phase
Exclusion Criteria
Must not be receiving any form of involuntary treatment, such as involuntary psychiatric hospitalization, parole-mandated treatment, or court-mandated treatment
Must not have attempted suicide within 12 months before screening and must not be at imminent risk of suicide or violent behavior, as clinically assessed by the investigator at the time of screening
Must not have a DSM-5 diagnosis of moderate or severe substance use disorder (except for nicotine and caffeine) within 6 months of screening; however, acute or intermittent substance use prior to screening is not exclusionary, depending upon the clinical judgment of the investigator
Must not have a history of neuroleptic malignant syndrome or tardive dyskinesia
Must not have a history of intolerability or severe reactions to moderate or higher doses of antipsychotic medications and must not have any other factors that would, in the judgment of the investigator, indicate that treatment with moderate or higher doses of paliperidone palmitate would be intolerable or unsafe
Study Design
Study Description
Connect with a study center
Fundación para el Estudio y Tratamiento de las Enfermedades Mentales
Ciudad Autonoma De Buenos Aires, C1425AHQ
ArgentinaSite Not Available
Fundacion para el Estudio y Tratamiento de las Enfermedades Mentales
Ciudad Autónoma De Buenos Aires, C1133AAH
ArgentinaSite Not Available
Fundación para el Estudio y Tratamiento de las Enfermedades Mentales
Ciudad Autónoma De Buenos Aires, C1133AAH
ArgentinaSite Not Available
CEN
Cordoba, X5004FJF
ArgentinaSite Not Available
Sanatorio Prof. Leon S. Morra
Cordoba, X5009BIN
ArgentinaSite Not Available
Clinica Privada de Salud Mental Santa Teresa de Ávila
La Plata, B1904ADM
ArgentinaSite Not Available
Instituto de Neurociencias San Agustin
La Plata, 1900
ArgentinaSite Not Available
Instituto de Neurociencias San Agustín
La Plata, 1900
ArgentinaSite Not Available
C I A P Centro de investigacion y Asistencia en Psiquiatria
Rosario, 2000
ArgentinaSite Not Available
C.I.A.P. (Centro de investigación y Asistencia en Psiquiatría)
Rosario, 2000
ArgentinaSite Not Available
Royal Prince Alfred Hospital
Camperdown, 2050
AustraliaSite Not Available
The Lyell McEwin Hospital
Elizabeth Vale, 5112
AustraliaSite Not Available
Peninsula Therapeutic & Research Group
Frankston, 3199
AustraliaSite Not Available
Neuro Trials Victoria
Noble Park, 3174
AustraliaSite Not Available
Brain & Mind Research Institute
Sydney, 2050
AustraliaSite Not Available
Trial Tech Tecnologia em Pesquisas com Medicamentos
Curitiba, 80240-280
BrazilSite Not Available
Instituto Bairral de Psiquiatria
Itapira, 13970-905
BrazilSite Not Available
Hospital das Clinicas de Porto Alegre
Porto Alegre, 90035-903
BrazilSite Not Available
Ruschel Medicina e Pesquisa Clínica Ltda
Rio de Janeiro, 22270 060
BrazilSite Not Available
Proesq - Unifesp
Sao Paulo, 04020-060
BrazilSite Not Available
SPDM - Associacao Paulista para o Desenvolvimento da Medicina - Hospital Sao Paulo
Sao Paulo, 04020-060
BrazilSite Not Available
CPQuali Pesquisa Clinica LTDA ME
São Paulo, 01228-900
BrazilSite Not Available
Hospital Das Clinicas Da Faculdade De Medicina Da USP
São Paulo, 05403-903
BrazilSite Not Available
Instituto de Psiquiatria - Hcfmusp
São Paulo, 05403010
BrazilSite Not Available
Mental Health Center Prof. Dr. Ivan Temkov
Bourgas, 8001
BulgariaSite Not Available
State Psychiatric Hospital Pazardzhik
Pazardzhik, 4400
BulgariaSite Not Available
UMHAT 'Sveti Georgi'-Plovdiv
Plovdiv, 4002
BulgariaSite Not Available
State Psychiatric HospitalDr.Georgi Kissiov
Radnevo, 6260
BulgariaSite Not Available
Centre for Mental Health Prof.N.Shipkovenski EOOD
Sofia, 1377
BulgariaSite Not Available
Medical Center Intermedica, OOD
Sofia, 1680
BulgariaSite Not Available
City Clinic Medical Center Bregalnitsa EOOD
Varna, 9002
BulgariaSite Not Available
Psychiatricka ambulance, MUDr. Marta Holanova
Brno, 61500
CzechiaSite Not Available
NeuropsychiatrieHK, s.r.o.
Hradec Kralove-Vekose, 50341
CzechiaSite Not Available
A Shine S R O
Plzen, 31200
CzechiaSite Not Available
A-Shine s.r.o.
Plzen, 31200
CzechiaSite Not Available
Institut Neuropsychiatricke pece
Prague, 18600
CzechiaSite Not Available
Psychiatricka ambulance MUDr. Simona Papezova
Prague, 19000
CzechiaSite Not Available
PRAGTIS s.r.o.
Praha 2, 12000
CzechiaSite Not Available
Pragtis S R O
Praha 2, 12000
CzechiaSite Not Available
C.H.S. Charles Perrens
Bordeaux, 33076
FranceSite Not Available
Cabinet Psyché
Douai, 59500
FranceSite Not Available
CHRU La Colombière
Montpellier, 34090
FranceSite Not Available
CHU Caremeau
Nimes Cedex 9, 30029
FranceSite Not Available
Hopital Sainte Anne
Paris, 75674
FranceSite Not Available
CHU Saint-etienne
Saint Etienne Cedex 2, 42055
FranceSite Not Available
Hopital Sainte Musse
Toulon Cedex, 83000
FranceSite Not Available
Hôpital Sainte Musse
Toulon Cedex, 83000
FranceSite Not Available
Praxis Dr. med. Jana Thomsen
Berlin, 10245
GermanySite Not Available
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
Mainz, 55131
GermanySite Not Available
Pharmakologisches Studienzentrum Chemnitz GmbH
Mittweida, 09648
GermanySite Not Available
Frank Kühn - Germany
Oranienburg, 16515
GermanySite Not Available
Kwai Chung Hospital
Hong Kong,
Hong KongSite Not Available
Queen Mary Hospital
Hong Kong,
Hong KongSite Not Available
Józsefvarosi Szent Kozma Egészségügyi Központ
Budapest, 1084
HungarySite Not Available
Petz Aladar Megyei Oktato Korhaz
Gyor, 9023
HungarySite Not Available
Petz Aladar Megyei Oktato Korhaz
Győr, 9023
HungarySite Not Available
Bács-Kiskun Megyei Kórház a Szegedi Tudományegyetem Általános Orvostudományi Kar Oktató Kórháza
Kalocsa, 6300
HungarySite Not Available
Kiskunhalasi Semmelweis Kórház
Kiskunhalas, 6400
HungarySite Not Available
CRU Hungary Kft.
Miskolc, 3529
HungarySite Not Available
Ratandeep Multispeciality Hospital
Ahmedabad, 380008
IndiaSite Not Available
National Institute of Mental Health And Neurosciences
Bengaluru, 560029
IndiaSite Not Available
Post Graduate Institute of Medical Education & Research (PGIMER)
Chandigarh, 160012
IndiaSite Not Available
Sri Ramachandra Medical Centre
Chennai, 600116
IndiaSite Not Available
Asha hospital
Hyderabad, 500034
IndiaSite Not Available
Ahana Hospitals
Madurai, 625020
IndiaSite Not Available
Vinaya Hospital and Research Center
Mangalore, 575003
IndiaSite Not Available
Kasturba Medical College Hospital
Manipal, 576104
IndiaSite Not Available
Jehangir Clinical Development Center Pvt Ltd
Pune, 411001
IndiaSite Not Available
Deva Institute of Health Care and Research Pvt Ltd
Varanasi, 221005
IndiaSite Not Available
VIMHANS Hospital
Vijayawada, 520002
IndiaSite Not Available
Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari
Bari, 70124
ItalySite Not Available
Clinica Psichiatrica - Università di Cagliari
Cagliari, 09127
ItalySite Not Available
Dipartimento di Salute Mentale
Lecce, 73100
ItalySite Not Available
Seconda Universita degli Studi di Napoli - Azienda Ospedaliera Universitaria
Napoli, 80138
ItalySite Not Available
Universita degli Studi di Roma 'La Sapienza' - Azienda Ospedaliera Sant Andrea
Roma, 00189
ItalySite Not Available
Chonnam National University Hospital
Gwangju, 61469
Korea, Republic ofSite Not Available
CHA Bundang Medical Center, CHA University
Gyeonggi-do, 13496
Korea, Republic ofSite Not Available
Chonbuk National Univ Hospital
Jeonju, 54907
Korea, Republic ofSite Not Available
CHA Bundang Medical center, CHA University
Seongnam, 13496
Korea, Republic ofSite Not Available
Seoul National University Hospital
Seoul, 03080
Korea, Republic ofSite Not Available
Hospital Bahagia Ulu Kinta
Ipoh, 31250
MalaysiaSite Not Available
Hospital Kuala Lumpur
Kuala Lumpur, 50586
MalaysiaSite Not Available
University Malaya Medical Centre
Kuala Lumpur, 59100
MalaysiaSite Not Available
Sarawak General Hospital
Kuching, 93586
MalaysiaSite Not Available
Centro de Estudios Clinicos y Especialidades Medicas, S.C.
Mexico, 66400
MexicoSite Not Available
Gabipros SC
Mexico City, 07810
MexicoSite Not Available
Gabipros SC.
Mexico City, 07810
MexicoSite Not Available
Centro de Estudios Clinicos y Especialidades Medicas S C
Monterrey, 64620
MexicoSite Not Available
Centro de Estudios Clinicos y Especialidades Medicas, S.C.
Monterrey, 64620
MexicoSite Not Available
Infosame/Research
Monterrey, 64710
MexicoSite Not Available
Instituto Neuropsique
Monterrey, 64610
MexicoSite Not Available
Centro de Atencion e Investigacion Cardiovascular del Potosi S C
San Luis Potosí, 78200
MexicoSite Not Available
Centro de Atencion e Investigacion Cardiovascular del Potosi, S.C.
San Luis Potosí, 78200
MexicoSite Not Available
Centro de Atención e Investigación Cardiovascular del Potosí, S.C.
San Luis Potosí, 78200
MexicoSite Not Available
Mlynowamed Specjalistyczny Psychiatryczny Gabinet Lekarski Joanna Lazarczyk
Bialystok, 15-404
PolandSite Not Available
Wlokiennicza MED Specjalistyczna Praktyka Lekarska dr n.med. Tomasz Markowski
Bialystok, 15-464
PolandSite Not Available
Zespol Opieki Zdrowotnej w Chelmnie
Chelmno, 86-200
PolandSite Not Available
Centrum Badan Klinicznych PI House sp z o o
Gdansk, 80 546
PolandSite Not Available
Centrum Badań Klinicznych PI-House sp. z o.o.
Gdansk, 80-546
PolandSite Not Available
Medica Centrum Badań spółka z o.o.
Gdańsk, 80-126
PolandSite Not Available
Szpital Specjalistyczny im H Klimontowicza Oddzial Psychiatryczny
Gorlice, 38-300
PolandSite Not Available
Szpital Specjalistyczny im. H. Klimontowicza, Oddzial Psychiatryczny
Gorlice, 38-300
PolandSite Not Available
Niepubliczny Zaklad Opieki Psychiatrycznej MENTIS
Leszno, 64-100
PolandSite Not Available
Centrum Medyczne Luxmed Sp z o o
Lublin, 20 109
PolandSite Not Available
Poradnia Zdrowia Psychicznego 'Syntonia' w Pruszczu Gdanskim
Pruszcz Gdanski, 83-000
PolandSite Not Available
NZOZ Syntonia
Pruszcz Gdański, 83-000
PolandSite Not Available
Mazowieckie Specjalistyczne Centrum Zdrowia im. Prof. Jana Mazurkiewicza w Pruszkowie
Pruszkow, 05-802
PolandSite Not Available
Wojewodzki Szpital Zespolony im L Rydygiera w Toruniu
Torun, 87 100
PolandSite Not Available
Wojewodzki Szpital Zespolony im. L. Rydygiera w Toruniu
Torun, 87-100
PolandSite Not Available
Neomed Medical Center
Brasov, 500283
RomaniaSite Not Available
Spitalul Clinic Judetean de Urgenta
Cluj-Napoca, 400012
RomaniaSite Not Available
Spitalul Clinic de Neuropsihiatrie
Craiova, 200473
RomaniaSite Not Available
Institutului Regional de Psihiatrie "Socola" Iasi
Iasi, 700282
RomaniaSite Not Available
Spitalul Clinic Judetean Mures
Targu Mures, 540139
RomaniaSite Not Available
Sverdlovsk Regional Clinical Psychiatric Hospital
Ekaterinburg,
Russian FederationSite Not Available
Clinical Psychiatric Hospital #3 Named After V.A. Gilyarovsky
Moscow, 107076
Russian FederationSite Not Available
Psychiatric Clinical hospital 1 named after N.A. Alekseev
Moscow, 117152
Russian FederationSite Not Available
Nizny Novgorod clinical psychiatric hospital 1
Nizny Novgorod, 603155
Russian FederationSite Not Available
SHI 'Saratov City Clinical Hospital 2 n.a V.I. Razumovsky
Saratov, 410028
Russian FederationSite Not Available
Saratov Regional Psychiatric hospital named after St. Sofia
Saratov, 410060
Russian FederationSite Not Available
Psychoneurological Dispensary of Frunzensky District
St-Petersburg, 190013
Russian FederationSite Not Available
Psychoneurological dispensary 1
St-Petersburg, 199178
Russian FederationSite Not Available
Psychoneurological dispensary 10
St-Petersburg, 190121
Russian FederationSite Not Available
St-Petersburg Bekhterev Psychoneurological Research Institute
St-Petersburg, 192109
Russian FederationSite Not Available
Psychoneurological Dispensary #4
St.Peterburg, 197110
Russian FederationSite Not Available
Research Institute of Mental Health
Tomsk, 634014
Russian FederationSite Not Available
Flexivest 14 Research
Cape Town, 7550
South AfricaSite Not Available
Gert Bosch - Pretoria South Africa
Pretoria, 0042
South AfricaSite Not Available
Gert Bosch Pretoria South Africa
Pretoria, 0042
South AfricaSite Not Available
Juan Schrönen - Western Cape South Africa
Welgemoed, 7530
South AfricaSite Not Available
Hosp Univ Vall D Hebron
Barcelona, 08035
SpainSite Not Available
Hosp. Univ. Vall D Hebron
Barcelona, 08035
SpainSite Not Available
Inst. Internac. Neurociencias Aplicadas
Barcelona, 8006
SpainSite Not Available
Hosp. Univ. de Basurto
Bilbao, 48013
SpainSite Not Available
Centro Salud Mental La Corredoria
Oviedo, 33011
SpainSite Not Available
Hosp. El Bierzo
Ponferrada, 24404
SpainSite Not Available
Hosp. Univ. de Torrevieja
Torrevieja, 03186
SpainSite Not Available
Hosp. Clinico Univ. de Valencia
Valencia, 46010
SpainSite Not Available
Hosp. Prov. de Zamora
Zamora, 49021
SpainSite Not Available
National Cheng Kung University Hospital
Tainan, 70403
TaiwanSite Not Available
Mackay Memorial Hospital
Taipei, 10449
TaiwanSite Not Available
Taipei Veterans General Hospital
Taipei, 11217
TaiwanSite Not Available
Chang Gung Memorial Hospital
Taoyuan, 333
TaiwanSite Not Available
Abdurrah Yurtarslan Training and Research Hospital
Ankara, 6200
TurkeySite Not Available
Ankara Numune Research and Training Hospital
Ankara, 6800
TurkeySite Not Available
Erenkoy Mental Health Hospital
Istanbul, 34736
TurkeySite Not Available
Selcuk University, Medical School, Department of Psychiatry
Konya, 42130
TurkeySite Not Available
Sakarya University Medical Faculty Psychiatry Department
Sakarya, 54187
TurkeySite Not Available
Chernigiv Regional Psychoneurological Hospital
Chernigiv, 14005
UkraineSite Not Available
MNCE of Kyiv RC Regional Psychiatric and Narcological Medical Association
Glevakha, 8630
UkraineSite Not Available
Mnpe of Kharkiv Regional Council 'Regional Clinical Psychiatric Hospital #3'
Kharkiv, 61068
UkraineSite Not Available
CNPE'Kherson Regional Institution of Mental Care'of Kherson Regional Council
Kherson, 73488
UkraineSite Not Available
Kyiv Territorial Medical Incorporation 'Psychiatry'
Kyiv, 04080
UkraineSite Not Available
CNCE of the Lviv Regional Council 'Lviv Regional Clinical Psychiatric Hospital'
Lviv, 79021
UkraineSite Not Available
Municipal Institution 'Lviv Regional Clinical Psycho-Neurological Dispensary'
Lviv, 79017
UkraineSite Not Available
CNCE Odesa regional psychiatric hospital #2 Odesa regional council
Oleksandrivka, 67513
UkraineSite Not Available
CNCE'Odesa regional psychiatric hospital #2" Odesa regional council'
Oleksandrivka, Kominternivskyi District, 67513
UkraineSite Not Available
CNCE 'Cherkasy Regional Psychiatric Hospital of Cherkasy Regional Council'
Smila, 20708
UkraineSite Not Available
CNCE 'Vinnytsya RC Psychoneurological Hospital n.a. O.I. Yushchenko Vinnytsya RC'
Vinnytsia, 21005
UkraineSite Not Available
Woodland Research Northwest
Rogers, Arkansas 72758
United StatesSite Not Available
California Pharmaceutical Research Institute, Inc.
Anaheim, California 92804
United StatesSite Not Available
ATP Clinical Research
Costa Mesa, California 92626
United StatesSite Not Available
Collaborative NeuroScience Network
Garden Grove, California 92845
United StatesSite Not Available
Synergy East
Lemon Grove, California 91945
United StatesSite Not Available
Pacific Research Partners
Oakland, California 94607
United StatesSite Not Available
SF-Care, Inc
San Rafael, California 94901
United StatesSite Not Available
New Life Medical Research Center, Inc.
Hialeah, Florida 33012
United StatesSite Not Available
Clintex Research Group
Miami, Florida 33135
United StatesSite Not Available
Florida Research Center Inc.
Miami, Florida 33174
United StatesSite Not Available
Medical Research Group of Central Florida
Orange City, Florida 32763
United StatesSite Not Available
New Life Medical Research Center, Inc.
Sanford, Florida 32771
United StatesSite Not Available
Olympian Clinical Research
Tampa, Florida 33614
United StatesSite Not Available
Atlanta Center for Medical Research
Atlanta, Georgia 30331
United StatesSite Not Available
Uptown Research Institute
Chicago, Illinois 60640
United StatesSite Not Available
Alexian Behavioral Health Hospital
Hoffman Estates, Illinois 60169
United StatesSite Not Available
Ascension via Christi Research
Wichita, Kansas 67214
United StatesSite Not Available
Massachusetts General Hospital
Boston, Massachusetts 02114
United StatesSite Not Available
Cherry Street Services, Inc.
Grand Rapids, Michigan 49503
United StatesSite Not Available
St. Louis Clinical Trials
Saint Louis, Missouri 63141
United StatesSite Not Available
The Zucker Hillside Hospital
Glen Oaks, New York 11004
United StatesSite Not Available
Clinical Trials of America Inc
Hickory, North Carolina 28601
United StatesSite Not Available
University Hospital of Cleveland
Cleveland, Ohio 44106
United StatesSite Not Available
Wexner Medical Center at the Ohio State University
Columbus, Ohio 43210
United StatesSite Not Available
Midwest Clinical Research Center
Dayton, Ohio 45417
United StatesSite Not Available
University of Pennsylvania Medical Center
Philadelphia, Pennsylvania 19104
United StatesSite Not Available
Future Search Trials of Dallas
Dallas, Texas 75231
United StatesSite Not Available
The Center for Health Care Services
San Antonio, Texas 78208
United StatesSite Not Available
Psychiatric and Behavioral Solutions
Salt Lake City, Utah 84105-2425
United StatesSite Not Available
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