Extension Study of Pimavanserin for the Adjunctive Treatment of Schizophrenia
August 15, 2023 updated by: ACADIA Pharmaceuticals Inc.
A 52-Week, Open-Label, Extension Study of Pimavanserin for the Adjunctive Treatment of Schizophrenia
To evaluate the long-term safety and tolerability of pimavanserin after 52 weeks of adjunctive treatment in subjects with schizophrenia
Study Overview
Study Type
Interventional
Enrollment (Estimated)
500
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Dragana Bugarski-Kirola, MD
- Phone Number: 609-250-6903
- Email: dbugarski-kirola@acadia-pharm.com
Study Contact Backup
- Name: Sandra Filosi
- Phone Number: 609-250-6920
- Email: sfilosi@acadia-pharm.com
Study Locations
-
-
-
Buenos Aires, Argentina
- Not yet recruiting
- 610-Clinica Privada Banfield S.A.
-
Ciudad Autonoma Buenos Aires, Argentina
- Recruiting
- 603-Fundación para el Estudio y Tratamiento de las Enfermedades Mentales - FETEM
-
Ciudad Autonoma de Buenos Aire, Argentina
- Recruiting
- 601-CENydET- Centro Neurobiologico y de Estres Traumatico-Biopsychomedical Research Group SRL
-
Ciudad Autonoma de Buenos Aire, Argentina
- Recruiting
- 602-FunDamoS
-
Ciudad Autonoma de Buenos Aires, Argentina
- Not yet recruiting
- 625-NOVAIN Neurociencias Group
-
Ciudad de Mendoza, Argentina
- Recruiting
- 607-Resolution Psicopharmacology Research Institute
-
Cordoba, Argentina
- Not yet recruiting
- 626-Sanatorio Prof. Leon S. Morra S.A.
-
Córdoba, Argentina
- Not yet recruiting
- 622-Instituto Medico Damic Srl
-
Córdoba, Argentina
- Not yet recruiting
- 624-Centro Especializado en Neurociencias CEN
-
La Plata, Argentina
- Recruiting
- 617-INSA Instituto de Neurociencias San Agustin S.A.
-
La Plata, Argentina
- Not yet recruiting
- 623-Clinica Privada de Salud Mental Santa Teresa de Avila
-
-
-
-
-
Burgas, Bulgaria, 8000
- Recruiting
- 454-Mental Health Centre 'Prof. Dr. Ivan Temkov', EOOD
-
Kardzhali, Bulgaria, 6600
- Recruiting
- 533-State Psychiatric Hospital - Kardzhali, EOOD
-
Kazanlak, Bulgaria
- Recruiting
- 532-MHAT "Dr. Hristo Stambolski", EOOD
-
Lovech, Bulgaria, 5500
- Recruiting
- 569-State Psychiatric Hospital - Lovech
-
Pazardzhik, Bulgaria, 4400
- Completed
- 406-State Psychiatric Hospital - Pazardzhik AD
-
Pleven, Bulgaria
- Recruiting
- 535-UMHAT 'Dr. Georgi Stranski', EAD
-
Plovdiv, Bulgaria, 4004
- Recruiting
- 586-Medical Center Mentalcare OOD
-
Plovdiv, Bulgaria, 4028
- Completed
- 563-MC-Hipokrat-N E00D
-
Plovdiv, Bulgaria
- Recruiting
- 592-Medical center Spectar - Plovdiv EOOD
-
Plovdiv, Bulgaria
- Completed
- 403-University Multiprofile hospital for activated treatment Sveti Georgi, Clinic of psychiatry
-
Sofia, Bulgaria, 1113
- Recruiting
- 570-Medical Centre "Sveti Naum"
-
Sofia, Bulgaria, 1408
- Recruiting
- 526-DCC "Sv. Vrach and Sv. Sv. Kuzma and Damyan", OOD
-
Sofia, Bulgaria, 1510
- Recruiting
- 568-Medical Center Hera EOOD
-
Sofia, Bulgaria, 1680
- Recruiting
- 528-Medical Center Intermedica, OOD
-
Sofia, Bulgaria, 1202
- Completed
- 497-MHC - Sofia, EOOD
-
Sofia, Bulgaria, 1431
- Completed
- 402-Military Medical Academy, Multiprofile Hospital for Actie Treatment - Sofia
-
Sofia, Bulgaria, 1431
- Recruiting
- 405-UMHAT "Alexandrovska" EAD
-
Targovishte, Bulgaria, 7700
- Completed
- 404-MHAT-Targovishte, AD
-
Tsarev Brod, Bulgaria
- Not yet recruiting
- 590-State Psychiatric Hospital - Tzarev Brod
-
Tserova Koria, Bulgaria, 5047
- Withdrawn
- 407-State Psychiatric Hospital - Tserova Koria
-
Varna, Bulgaria, 9020
- Recruiting
- 498-DCC "Mladost M" - Varna, OOD
-
Veliko Tarnovo, Bulgaria, 5000
- Recruiting
- 455-Mental Health Center - Veliko Tarnovo EOOD
-
Vratsa, Bulgaria, 3000
- Recruiting
- 401-Mental Health Center-Vratsa EOOD
-
-
-
-
-
Chatham, Canada, N7L 1C1
- Completed
- 356-Chatham-Kent Clinical Trials Research Ctr
-
Kingston, Canada, K7L 4X3
- Withdrawn
- 354-Queens University at Kingston, Providence Care Hospital
-
Mississauga, Canada, L5M 4N4
- Withdrawn
- 355-Sunny Johnson Medical Research Associates
-
Penticton, Canada, V2A 4M4
- Withdrawn
- 357-Dr. Alexander McIntyre Inc.
-
-
British Columbia
-
Penticton, British Columbia, Canada, V2A 4M4
- Withdrawn
- Dr. Alexander McIntyre Inc.
-
-
Ontario
-
Chatham, Ontario, Canada, N7L1C1
- Completed
- Chatham-Kent Clinical Trials Research Ctr
-
Toronto, Ontario, Canada, M6J 1H4
- Withdrawn
- 352 - Centre for Addiction and Mental Health
-
-
Quebec
-
Montréal, Quebec, Canada, H3A 1A1
- Completed
- 351-McGill University Health Ctr Allan Memorial Int.
-
-
-
-
-
Zagreb, Croatia
- Not yet recruiting
- 594-Klinika za psihijatriju Sveti Ivan, n/p Igor Filipčić or Marija Zelenika
-
Zagreb, Croatia
- Not yet recruiting
- 536 - Clinic for psychiatry Vrapce
-
Zagreb, Croatia
- Recruiting
- 537 - Clinic for psychiatry Vrapce
-
Zagreb, Croatia
- Not yet recruiting
- 550-Clinic for psychiatry Vrapce
-
Zagreb, Croatia
- Recruiting
- 557 - Clinic for psychiatry Vrapce
-
-
-
-
-
Hradec Králové, Czechia, 50341
- Recruiting
- 512-NeuropsychiatrieHK s.r.o.
-
Klecany, Czechia
- Recruiting
- 583-Narodni ustav dusevniho zdravi
-
Plzen, Czechia, 31200
- Recruiting
- 519-A-SHINE s.r.o.
-
Praha 10, Czechia, 10000
- Completed
- 513-CLINTRIAL s.r.o.
-
Praha 10, Czechia, 10600
- Completed
- 499-MUDr. Tibor Miklos
-
Praha 6, Czechia, 16000
- Withdrawn
- 491-MEDICAL SERVICES PRAGUE s.r.o.
-
Říčany, Czechia, 25101
- Completed
- 511-Psychiatrie Ricany s.r.o.
-
-
-
-
-
Budapest, Hungary, 1135
- Completed
- 520-Nyiro Gyula Korhaz - Orszagos Pszichiatriai es Addiktologiai Intezet
-
Budapest, Hungary, 1084
- Withdrawn
- 521-Jozsefvarosi Szent Kozma Egeszsegugyi Kozpont
-
Debrecen, Hungary, 4032
- Withdrawn
- 527-Debreceni Egyetem
-
Gyula, Hungary, 5700
- Withdrawn
- 412-Békés Megyei Központi Kórház/Pszichiátria osztály
-
Pécs, Hungary, 7633
- Recruiting
- 440-PsychoTech Kft.
-
Székesfehérvár, Hungary
- Withdrawn
- 489-St. Gyorgy Hospital
-
-
Bács-Kiskun Megye
-
Kalocsa, Bács-Kiskun Megye, Hungary, 6300
- Recruiting
- 410-Dr. Máthé és Társa Bt.
-
-
Pest Megye
-
Budapest, Pest Megye, Hungary, 1036
- Completed
- 411-ÓBudai Egészségűgyi Centrum Kft
-
Budapest, Pest Megye, Hungary, 1083
- Recruiting
- 456-Semmelweis University Department of Psychiatry and Psychotherapy
-
-
-
-
-
Bari, Italy
- Withdrawn
- 580-AOU Consorziale Policlinico di Bari
-
Lido di Camaiore, Italy
- Withdrawn
- 552-Ospedale Versilia, UOC Psichiatria
-
Milano, Italy
- Withdrawn
- 539-Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico U.O.C. Psichiatria - Padiglione Alfieri, primo piano
-
Milano, Italy
- Recruiting
- 566-Ospedale San Raffaele (San Raffaele Turro)
-
Monza, Italy
- Withdrawn
- 577-ASST di Monza (Presidio San Gerardo)
-
Torino, Italy
- Not yet recruiting
- 553-AO Città della Salute e della Scienza di Torino
-
-
-
-
-
Kaunas, Lithuania, LT-44279
- Completed
- 483-Romuvos klinika, UAB
-
Kaunas, Lithuania, LT-48259
- Completed
- 518-Kaunas City Outpatient Clinic, Public Institution
-
Kaunas, Lithuania, 50185
- Withdrawn
- 516-Neuromeda, JSC
-
Silute, Lithuania, 99142
- Withdrawn
- Silutes Mental Health and Psychotherapy Center, JSC
-
Silute, Lithuania
- Completed
- 484-Medical Center Puriena JSC
-
Vilnius, Lithuania, 09112
- Completed
- 517-Zirmunai Mental Health Center, Public Institution
-
Vilnius, Lithuania, 10204
- Withdrawn
- 514-Antakalnis Psychiatric Consultation Center, Public Institution
-
-
-
-
-
Białystok, Poland, 15-756
- Recruiting
- 525-Podlaskie Centrum Psychogeriatrii
-
Bydgoszcz, Poland, 85-080
- Completed
- 502-Przychodnia Srodmiescie Sp. z o. o.
-
Bydgoszcz, Poland
- Withdrawn
- 442-Clinsante S.C. Osrodek Badan Klinicznych
-
Gdańsk, Poland, 80-546
- Recruiting
- 579-Centrum Badan Klinicznych P.I. House Sp. z o.o.
-
Katowice, Poland, 40-568
- Withdrawn
- 541-Care Clinic centrum Medyczne
-
Kobierzyce, Poland
- Withdrawn
- 503-NZOZ Poradnia Zdrowia Psychicznego
-
Lublin, Poland, 20-582
- Recruiting
- 501-Specjalistyczna Praktyka Lekarska Marek Domański
-
Lublin, Poland, 20-080
- Withdrawn
- 504-Centrum Medyczne "Luxmed" Sp. z o.o.
-
Pruszcz Gdański, Poland, 83-000
- Withdrawn
- 500-NZOZ Syntonia
-
Pruszków, Poland
- Not yet recruiting
- 578-MSCZ im. Prof. J. Mazurkiewicza
-
Torun, Poland, 87-100
- Withdrawn
- 540-Ośr. Badań Klin. CLINSANTE S.C.
-
-
-
-
-
Arkhangel'sk, Russian Federation, 163530
- Completed
- 418-State Budget Healthcare Institution of Arkhangelsk Region "Arkhangelsk Clinical Psychiatric Hospital"
-
Ekaterinburg, Russian Federation, 620030
- Withdrawn
- 506-Sverdlov Regional Psychiatric Clinical Hospital
-
Leningrad, Russian Federation, 188820
- Completed
- 419-State municipal healthcare Institution "Leningrad region psychoneurological center"
-
Moscow, Russian Federation, 115522
- Completed
- 459-Federal State Budgetary Research Institution "Mental Health Science Center"
-
Moscow, Russian Federation
- Recruiting
- 573-SBIH of Moscow "Psychiatric Clinical Hospital # 4 n.a. P.B. Gannushkin" Short name: PCH N4 n.a. P.B.Gannushkin
-
Moscow, Russian Federation
- Recruiting
- 581-SBIH of Moscow "Psych Clinical Hospital #1 N.A. Alekseev"
-
Saint Petersburg, Russian Federation, 190121
- Recruiting
- 415-Saint-Petersburg State Healthcare Institution "Saint Nicolas Wonderworker Psychiatric Hospital"
-
Saint Petersburg, Russian Federation, 192019
- Recruiting
- 451-V. M. Bekhterev National Research Medical Center For Psychiatry and Neurology
-
Saint Petersburg, Russian Federation, 192019
- Recruiting
- 453-"Saint-Petersburg Scientific Research Psychoneurological Institute n.a. V.M. Bekhterev"
-
Saint Petersburg, Russian Federation, 192019
- Recruiting
- 465-"Saint-Petersburg Scientific Research Psychoneurological Institute N.A. V.M. Bekhterev"
-
Saint Petersburg, Russian Federation, 192019
- Recruiting
- 495-FSBI "National Medical Scientifi Center of Psychiatry and Neurology n.a. V.M. Bekhterev" MoH
-
Saint Petersburg, Russian Federation, 197341
- Recruiting
- 444-SPHI "City Mental Hospital #3 n.a. I.I Skvortsov-Stepanov"
-
Saint Petersburg, Russian Federation, 197341
- Recruiting
- 452-Saint Petersburg State Public Institution of Healthcare "City Psychiatric Hospital #3 n.a.I.I. Skvortsov-Stepanov
-
Saint Petersburg, Russian Federation, 197341
- Recruiting
- 496-SPHI "City Mental Hospital #3 n.a. I.I Skvortsov-Stepanov
-
Saint Petersburg, Russian Federation, 443016
- Recruiting
- 458-State Budget Healthcare Institution "Samara Psychiatric Hospital"
-
Saint Petersburg, Russian Federation
- Withdrawn
- 490-SHI City Psychoneurological Dispensary #7 with Hospital
-
Saint Petersburg, Russian Federation, 195112
- Completed
- 443-Saint-Petersburg State Budget Healthcare Institution "Psychoneurological Center #5"
-
Saint-Petersburg, Russian Federation, 190121
- Recruiting
- 571-St. Petersburg SHI "Psychoneurological Dispensary #10"
-
Saint-Petersburg, Russian Federation, 193167
- Recruiting
- 464-Saint Petersburg State Budget Healthcare Institution "City Psychiatric Hospital No. 6 (Inpatient Department with Treatment Center)"
-
Smolensk, Russian Federation, 214019
- Recruiting
- 416-FSBEI HE "Smolensk State Medical University" of the MoH of the RF
-
Stavropol', Russian Federation, 355000
- Completed
- 420-"Podderzhka" Research and Educational Center of Psychotherapy Limited Liability Company
-
Tomsk, Russian Federation
- Recruiting
- 572-Klinika StoLet" Ltd.
-
Voronezh, Russian Federation, 394024
- Completed
- 466-OOO "Lion-Med"
-
Yaroslavl, Russian Federation, 150003
- Recruiting
- 422-State Budget Healthcare Institution of Yaroslavl Region "Yaroslavl Region Clinical Psychiatric Hospital"
-
-
Lipetsk Region
-
Plekhanovo, Lipetsk Region, Russian Federation, 399313
- Completed
- 505-GUZ Lipetsk Regional psychoneurological Hospital #1
-
-
Stavropol Region
-
Tonnel'nyy, Stavropol Region, Russian Federation, 357034
- Recruiting
- 417-State Budget Healthcare Institution of Stavropol Region (Regional Specialized Psychiatric Hospital #2)
-
-
-
-
-
Belgrad, Serbia, 11000
- Recruiting
- 587-Institute of Mental Health
-
Belgrad, Serbia
- Not yet recruiting
- 584-Clinic for Psychiatry, Clinical Canter of Serbia
-
Belgrad, Serbia, 11000
- Recruiting
- 424-Institute of Mental health
-
Belgrade, Serbia, 11000
- Recruiting
- 425-Clinical Hospital Center "Dr. Dragisa Misovic-Dedinje", Clinic of Psychiatry
-
Belgrade, Serbia, 11 000
- Completed
- 428-Clinical center of Serbia
-
Belgrade, Serbia, 11000
- Completed
- 471-Clinic for Psychiatric Diseases "Dr Laza Lazarevic"
-
Belgrade, Serbia, 11000
- Completed
- 524-General Hospital Euromedik
-
Belgrade, Serbia, 11000
- Withdrawn
- 522-Military Medical Academy Clinic of Psychiatry
-
Kovin, Serbia, 26220
- Completed
- 472-Special Hospital for Psychiatric Diseases "Kovin"
-
Kovin, Serbia, 26220
- Completed
- 493-Special Neuropsychiatric Hospital Kovin
-
Kragujevac, Serbia, 34 000
- Recruiting
- 423-Clinical Center Kragujevac
-
Kragujevac, Serbia, 34 000
- Completed
- 429-Clinical Center Kragujevac, Clinic of Psychiatry
-
Kragujevac, Serbia
- Recruiting
- 430-Psychiatric Clinic, Clinical Center Kragujevac
-
Nis, Serbia, 18 000
- Recruiting
- 427-Clinical Center Nis, Clinic of Mental Health
-
Niš, Serbia
- Recruiting
- 585-Special Hospital for Psychiatric Diseases "Gornja Toponica"
-
Novi Kneževac, Serbia
- Not yet recruiting
- 593-Specialized Hospital for Neuropsychiatric Diseases "Sveti Vracevi"
-
-
-
-
-
Barcelona, Spain, 08830
- Completed
- 476-FIDMAG Germanes Hospitalaries
-
Barcelona, Spain
- Recruiting
- 574-Hospital Clinic de Barcelona
-
Barcelona, Spain
- Withdrawn
- 576-Hospital Universitari Vall d'Hebron
-
Barcelona, Spain
- Not yet recruiting
- 588-Institucion Hospitalaria Hestia Palau - Ensayos clinicos
-
Madrid, Spain
- Withdrawn
- 445-Hospital del Henares
-
Madrid, Spain, 28007
- Completed
- 475-Hospital Gregorio Marañon
-
Madrid, Spain
- Recruiting
- 575-Hospital Universitario 12 de Octubre
-
Oviedo, Spain, 33011
- Recruiting
- 494-CSM La Corredoria
-
Valladolid, Spain, 47016
- Recruiting
- 431-Centro de Salud Parquesol, 2ª planta - Servicio de Psiquiatria
-
Zamora, Spain, 49021
- Recruiting
- 529-Hospital Provincial de Zamora
-
-
-
-
-
Chernihiv, Ukraine
- Withdrawn
- 436-Public Medicoprophylactic Institution "Chernihiv Regional Psychoneurologic Hospital", Psychiatric Department #18
-
Dnipro, Ukraine, 49005
- Completed
- 462-Communal Establishment "I.I. Mechnykov Dnipropetrovsk Regional Clinical Hospital"
-
Hlevakha, Ukraine, 08631
- Completed
- 510-CI of Kyiv RC Regional Psychiatric-Narcological Medical Association, Depart #10 (male), Dept #2 (female)
-
Kharkiv, Ukraine, 61068
- Recruiting
- 434-State Institution "Institute of Neurology, Psychiatry and Narcology of NAMS of Ukraine", Department of Urgent Psychiatry and Narcology
-
Kharkiv, Ukraine, 61068
- Recruiting
- 582-SI Institute of Neurology,Psychiatry&Narcology of NAMSU
-
Kharkiv, Ukraine
- Recruiting
- 567-CIH Kharkiv Regional Clinical Psychiatric Hospital #3 Psychiatric Department of Primary Psychotic Episod Short Site name: CIH KRCPH #3 PD of PPE
-
Kharkiv, Ukraine, 61068
- Completed
- 433-SI "Institute of Neurology, Psychiatry and Narcology of National Academy of Medical Sciences of Ukraine"
-
Kherson, Ukraine, 73488
- Completed
- 461-Kherson Regional Psychiatric Hospital
-
Kyiv, Ukraine, 04080
- Recruiting
- Kyiv Regional Medical Incorporation Psychiatry Center of Novel Treatment and Rehabilitation of Psychotic Disorders, Department #29, Department #30
-
Kyiv, Ukraine, 01133
- Completed
- 507-Main Military Clinical Hospital of MDU
-
Kyiv, Ukraine
- Recruiting
- 435-Kyiv Regional Medical Incorporation "Psychiatry". Center of Novel Treatment and Rehabilitation of Psychotic disorders, build 5, Department #30
-
Kyiv, Ukraine
- Withdrawn
- 565-Kyiv CH on Railway Transport #2 of Branch Center of Healthcare Public Company Ukr Railway Short site name: Kyiv Railway Clinical Hospital № 2
-
Kyiv, Ukraine, 02192
- Withdrawn
- 437-Kyiv City Psychoneurological Hospital #2 Kyiv City Psychoneurological Hospital #2 Consultative Department
-
Kyiv, Ukraine, 04080
- Completed
- 447-Ukrainian Scientific Research Institute of Social and Forensic Psychiatry and Narcology of Ministry of Healthcare of Ukraine
-
Kyiv, Ukraine, 08631
- Completed
- 460-Kyiv City Psychoneurological Hospital #3, General Psychiatry Department No. 2
-
Lviv, Ukraine, 79017
- Withdrawn
- 523-CI of LRC Lviv Regional Psychoneurology Dispensary
-
Lviv, Ukraine, 79021
- Withdrawn
- 446-CI Lviv Regional Clinical Psychiatric Hospital Dept #20
-
Nove, Ukraine
- Recruiting
- 564-Regional Clinical Psychiatric Hospital
-
Odesa, Ukraine, 65014
- Recruiting
- 509-CI Odesa Regional Medical Centre of Mental Health
-
Poltava, Ukraine, 36013
- Withdrawn
- 448-Poltava Regional Clinical Psychiatric Hospital n.a. O.F. Maltsev
-
Smila, Ukraine, 20708
- Recruiting
- 508-CI Cherkasy Regional Psychiatric Hospital of ChRC Female Dept #11, Male Dept #12
-
Vinnytsia, Ukraine, 21005
- Completed
- Communal Establishment "Acad. O.I. Iushchenko Vinnytsia Regional Psychoneurologic Hospital"
-
Vinnytsia, Ukraine
- Completed
- 432-Municipal Institution "Vinnytsya Regional Psychoneurological Hospital n.a. Acad. O.I. Yushchenko", Male Department No 14, Female Department No 15, Vinnytsya National Medical University n.a. M.I. Pyrogov, Dept of Psychiatry, Narcology and Psychothera
-
Úzhgorod, Ukraine
- Not yet recruiting
- 591-Municipal non-profit enterprise "Transcarpathian Regional Medical Center of Mental Health and Medicine of Addictions" of the Transcarpathian Regional Council, Department of psychiatry
-
-
Oblast
-
Odessa, Oblast, Ukraine, 67513
- Completed
- 438-Communal Establishment "Odesa Regional Psychiatric Hospital #2"
-
-
-
-
Arizona
-
Phoenix, Arizona, United States, 85012
- Completed
- 171-Alea Research Institute
-
-
Arkansas
-
Little Rock, Arkansas, United States, 72211
- Completed
- 156-Woodland International Research Group, LLC
-
Rogers, Arkansas, United States, 72758
- Completed
- 111-Woodland Research Northwest, LLC
-
-
California
-
Anaheim, California, United States, 92805
- Withdrawn
- 154-Advanced Research Center, Inc.
-
Bellflower, California, United States, 90706
- Completed
- 167-CITrials - Bellflower
-
Cerritos, California, United States, 90703
- Withdrawn
- 147-Comprehensive Clinical Development
-
Culver City, California, United States, 90230
- Completed
- 105-ProScience Research Group
-
Glendale, California, United States, 91206
- Withdrawn
- 121-Behavioral Research Specialists, LLC
-
Lemon Grove, California, United States, 91945
- Completed
- 123-Synergy San Diego
-
Long Beach, California, United States, 90822
- Withdrawn
- 126-Long Beach VA Healthcare System
-
Long Beach, California, United States, 90813
- Withdrawn
- 150-Apostle Clinical Trials, Inc.
-
Los Angeles, California, United States, 90024
- Withdrawn
- 120-Pacific Institute of Medical Research
-
Oakland, California, United States, 94607
- Withdrawn
- 107-Pacific Research Partners, LLC
-
San Diego, California, United States, 92103
- Completed
- 164-Artemis Institute for Clinical Research
-
San Diego, California, United States, 92123
- Withdrawn
- 122-Sharp Mesa Vista Hospital
-
Santa Ana, California, United States, 92705
- Completed
- 165-CITrials
-
Torrance, California, United States, 90502
- Completed
- 108-Collaborative Nueroscience Network, LLC
-
-
Connecticut
-
Norwalk, Connecticut, United States, 90650
- Withdrawn
- 112-Flagship Norwalk, LLC
-
-
Florida
-
Boca Raton, Florida, United States, 33431
- Withdrawn
- 158-Charles E. Schmidt College of Medicine Florida Atlantic University
-
Bradenton, Florida, United States, 34201
- Withdrawn
- 119-Meridien Research
-
Hialeah, Florida, United States, 33016
- Completed
- 125-Galiz Research
-
Jacksonville, Florida, United States, 32256
- Withdrawn
- 132-Clinical Neuroscience Solutions Inc.
-
Lauderhill, Florida, United States, 33319
- Completed
- 137-Innovative Clinical Research, Inc.
-
Miami, Florida, United States, 33122
- Completed
- 146-Premier Clinical Research Institute, Inc.
-
Miami, Florida, United States, 33136
- Withdrawn
- 149-Miller School of Medicine University of Miami
-
Orlando, Florida, United States, 32810
- Withdrawn
- 166-Meridien Research
-
Tampa, Florida, United States, 33613
- Withdrawn
- 163-Stedman Clinical Trials
-
-
Georgia
-
Atlanta, Georgia, United States, 30328
- Completed
- 162-Synexus Clinical Research, Inc.
-
Atlanta, Georgia, United States, 30331
- Completed
- 168-Atlanta Center for Medical Research
-
Augusta, Georgia, United States, 30912
- Withdrawn
- 135-Georgia Regents University, Department of Psychiatry & Behavioral Health
-
Decatur, Georgia, United States, 30030
- Withdrawn
- 152-iResearch Atlanta LLC
-
Marietta, Georgia, United States, 30060
- Completed
- 102-Northwest Behavioral Research Center
-
-
Illinois
-
Chicago, Illinois, United States, 60611
- Completed
- 114-Northwestern University
-
Chicago, Illinois, United States, 60612
- Completed
- 101-American Medical Research
-
Hoffman Estates, Illinois, United States, 60169
- Completed
- 130-Alexian Brothers Center for Psychiatric Research
-
-
Kansas
-
Wichita, Kansas, United States, 67214
- Withdrawn
- 133-Department of Psychiatry and Behavioral Sciences KU School of Medicine-Wichita - 133
-
-
Louisiana
-
Lake Charles, Louisiana, United States, 70629
- Completed
- 118-Lake Charles Clinical Trials
-
Shreveport, Louisiana, United States, 71101
- Withdrawn
- 116-Louisiana Clinical Research Center
-
-
Maryland
-
Catonsville, Maryland, United States, 21228
- Withdrawn
- 157-Maryland Psychiatric Research Center
-
-
Michigan
-
Ann Arbor, Michigan, United States, 48105
- Withdrawn
- 151-Michigan Clinical Research Institute PC
-
-
Mississippi
-
Flowood, Mississippi, United States, 39110
- Withdrawn
- 134-Precise Research Centers
-
-
Missouri
-
Saint Charles, Missouri, United States, 63304
- Withdrawn
- 113-St. Charles Psychiatric Associates Midwest Research Group
-
Saint Louis, Missouri, United States, 63110
- Withdrawn
- 148-Washington University School of Medicine St. Louis
-
Saint Louis, Missouri, United States, 63141
- Withdrawn
- 109-St. Louis Clinical Trials, LLC
-
-
Nebraska
-
Lincoln, Nebraska, United States, 68526
- Withdrawn
- 143-Premier Psychiatric Research Institute, LLC
-
-
Nevada
-
Las Vegas, Nevada, United States, 89102
- Completed
- 124-Altea Research Institute
-
-
New Jersey
-
Berlin, New Jersey, United States, 08009
- Completed
- 141-Hassman Research Institute
-
Marlton, New Jersey, United States, 08053
- Withdrawn
- 169-PRA Health Sciences
-
-
New Mexico
-
Albuquerque, New Mexico, United States, 87109
- Completed
- 153-Albuquerque Neuroscience Inc.
-
-
New York
-
Cedarhurst, New York, United States, 11516
- Completed
- 104-Neurobehavioral Research, Inc.
-
Jamaica, New York, United States, 11432
- Completed
- 140-Synexus Clinical Research, Inc - 140
-
Rochester, New York, United States, 14618
- Completed
- 128-Finger Lakes Clinical Research
-
-
North Carolina
-
Charlotte, North Carolina, United States, 28211
- Completed
- 106-New Hope Clinical Research
-
Durham, North Carolina, United States, 27704
- Completed
- 145-Carolina Behavioral Care
-
-
Ohio
-
Cleveland, Ohio, United States, 44106
- Withdrawn
- 139-University Hospitals Cleveland Medical Center
-
Dayton, Ohio, United States, 45417
- Withdrawn
- 138-Midwest Clinical Research Center
-
Shaker Heights, Ohio, United States, 44122
- Withdrawn
- 129-Insight Clinical Trials, LLC
-
-
Oklahoma
-
Oklahoma City, Oklahoma, United States, 73116
- Completed
- 110-Cutting Edge Research Group
-
-
Pennsylvania
-
Downingtown, Pennsylvania, United States, 19335
- Completed
- 170-Suburban Research Associates
-
-
South Carolina
-
Charleston, South Carolina, United States, 29407
- Withdrawn
- 144-Carolina Clinical Trials, Inc.
-
-
Texas
-
Houston, Texas, United States, 77007
- Withdrawn
- 155-Bayou City Research, Ltd.
-
Irving, Texas, United States, 75062
- Completed
- 127-University Hills Clinical Research
-
Richardson, Texas, United States, 75080
- Completed
- 103-Pillar Clinical Research, LLC
-
-
Utah
-
Salt Lake City, Utah, United States, 84105
- Completed
- 115-Psychiatric and Behavioral Solutions LLC
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Patient is able to understand and provide signed informed consent
- Has a caregiver or some other identified responsible person (e.g., family member, social worker, caseworker, or nurse) considered reliable by the Investigator in providing support to the subject to help ensure compliance with study treatment, study visits, and protocol procedures and who is also able to provide input helpful for completing study rating scale
- Is completing the Week 6 visit in Study ACP-103-034 or the Week 26 visit in Study ACP-103-038 or 064 while continuing to take his/her assigned dose of blinded study drug and may, in the Investigator's opinion, benefit from continued adjunctive treatment with pimavanserin to a antipsychotic
- If the subject is female, she must not be pregnant or breastfeeding. She must also be of non-childbearing potential (defined as either surgically sterilized or at least 1 year postmenopausal) or must agree to use two clinically acceptable methods of contraception
The main background antipsychotic with which the subject is being treated must continue to be on one of the antipsychotics listed below:
- Aripiprazole
Aripiprazole long-acting injectables:
- Abilify Maintena®
- Aristada®
- Asenapine
- Risperidone
- Risperidone long-acting injection
- Olanzapine
- Paliperidone extended release (ER) (≤9 mg)
Paliperidone palmitate
- Invega Sustenna® (≤156 mg)
- Invega Trinza® (≤546 mg)
- Trevicta® (≤350 mg)
- Xeplion® (≤100 mg)
- Lurasidone
- Cariprazine
- Brexpiprazole
- Asenapine
Exclusion Criteria:
- Patient is judged by the Investigator or the Medical Monitor to be inappropriate for the study (e.g., significantly noncompliant in Studies ACP-103-034, -038, or -064)
A urine drug screen (UDS) result at Baseline that indicates the presence of any tested prohibited substance of potential abuse
- Subjects from Studies 034 and 038 with a result indicating the presence of marijuana are permitted, if allowed by medical regulations, if they agree to abstain from marijuana use during the study and the medical monitor approves the subject's participation
- Subjects from Study 064 with a result indicating the presence of marijuana are not permitted in the study
- Is taking a medication or drug or other substance that is prohibited according to this protocol
- Known family or personal history or symptoms of long QT syndrome or risk factors for torsade de pointes and/or sudden death, including symptomatic bradycardia, hypokalemia or hypomagnesemia, and the presence of congenital prolongation of the QT interval
- Patient has current evidence of a serious and/or unstable psychiatric, neurologic, cardiovascular, respiratory, gastrointestinal, renal, hepatic, hematologic, or other medical disorder, including cancer or malignancies, which would affect the patient's ability to participate in the study.
Patients will be evaluated at screening to ensure that all criteria for study participation are met. Patients may be excluded from the study based on these assessments (and specifically if it is determined that their baseline health and psychiatric condition do not meet all pre-specified entry criteria).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Drug - Pimavanserin
Pimavanserin 34 mg, 20 mg, or 10 mg, + background antipsychotic, taken once daily by mouth
|
Pimavanserin 10 mg, tablet, taken as one 10 mg tablets, once daily by mouth, OR Pimavanserin 20 mg, tablet, taken as two 10 mg tablets, once daily by mouth, OR Pimavanserin 34 mg, tablet, taken as two 17 mg tablets, once daily by mouth
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Evaluate the long-term safety and tolerability of pimavanserin (e.g., Summary of Treatment-Emergent Adverse Events [Safety and Tolerability])
Time Frame: 52 weeks
|
Evaluate the long-term safety and tolerability of pimavanserin after 52 weeks of adjunctive treatment in subjects with schizophrenia
|
52 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2017
Primary Completion (Estimated)
March 1, 2024
Study Completion (Estimated)
March 1, 2024
Study Registration Dates
First Submitted
April 13, 2017
First Submitted That Met QC Criteria
April 17, 2017
First Posted (Actual)
April 20, 2017
Study Record Updates
Last Update Posted (Actual)
August 18, 2023
Last Update Submitted That Met QC Criteria
August 15, 2023
Last Verified
August 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Schizophrenia Spectrum and Other Psychotic Disorders
- Schizophrenia
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Antipsychotic Agents
- Tranquilizing Agents
- Psychotropic Drugs
- Serotonin Agents
- Serotonin 5-HT2 Receptor Antagonists
- Serotonin Antagonists
- Antiparkinson Agents
- Anti-Dyskinesia Agents
- Pimavanserin
Other Study ID Numbers
- ACP-103-035
- 2016-003435-38 (EudraCT Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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