Extension Study of Pimavanserin for the Adjunctive Treatment of Schizophrenia
NCT ID: NCT03121586
Last Updated: 2025-08-24
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
995 participants
INTERVENTIONAL
2017-01-31
2024-05-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Drug - Pimavanserin
Pimavanserin 34 mg, 20 mg, or 10 mg, + background antipsychotic, taken once daily by mouth
Pimavanserin
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
Interventions
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Pimavanserin
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
Eligibility Criteria
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Inclusion Criteria
2. 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
3. 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
4. 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
5. 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
2. A urine drug screen (UDS) result at Baseline that indicates the presence of any tested prohibited substance of potential abuse
1. 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
2. Subjects from Study 064 with a result indicating the presence of marijuana are not permitted in the study
3. Is taking a medication or drug or other substance that is prohibited according to this protocol
4. 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
5. 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).
18 Years
ALL
No
Sponsors
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ACADIA Pharmaceuticals Inc.
INDUSTRY
Responsible Party
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Locations
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171-Alea Research Institute
Phoenix, Arizona, United States
156-Woodland International Research Group, LLC
Little Rock, Arkansas, United States
111-Woodland Research Northwest, LLC
Rogers, Arkansas, United States
167-CITrials - Bellflower
Bellflower, California, United States
105-ProScience Research Group
Culver City, California, United States
123-Synergy San Diego
Lemon Grove, California, United States
164-Artemis Institute for Clinical Research
San Diego, California, United States
165-CITrials
Santa Ana, California, United States
108-Collaborative Nueroscience Network, LLC
Torrance, California, United States
125-Galiz Research
Hialeah, Florida, United States
137-Innovative Clinical Research, Inc.
Lauderhill, Florida, United States
146-Premier Clinical Research Institute, Inc.
Miami, Florida, United States
162-Synexus Clinical Research, Inc.
Atlanta, Georgia, United States
168-Atlanta Center for Medical Research
Atlanta, Georgia, United States
102-Northwest Behavioral Research Center
Marietta, Georgia, United States
114-Northwestern University
Chicago, Illinois, United States
101-American Medical Research
Chicago, Illinois, United States
130-Alexian Brothers Center for Psychiatric Research
Hoffman Estates, Illinois, United States
118-Lake Charles Clinical Trials
Lake Charles, Louisiana, United States
124-Altea Research Institute
Las Vegas, Nevada, United States
141-Hassman Research Institute
Berlin, New Jersey, United States
153-Albuquerque Neuroscience Inc.
Albuquerque, New Mexico, United States
104-Neurobehavioral Research, Inc.
Cedarhurst, New York, United States
140-Synexus Clinical Research, Inc - 140
Jamaica, New York, United States
128-Finger Lakes Clinical Research
Rochester, New York, United States
106-New Hope Clinical Research
Charlotte, North Carolina, United States
145-Carolina Behavioral Care
Durham, North Carolina, United States
110-Cutting Edge Research Group
Oklahoma City, Oklahoma, United States
170-Suburban Research Associates
Downingtown, Pennsylvania, United States
127-University Hills Clinical Research
Irving, Texas, United States
103-Pillar Clinical Research, LLC
Richardson, Texas, United States
115-Psychiatric and Behavioral Solutions LLC
Salt Lake City, Utah, United States
610-Clinica Privada Banfield S.A.
Buenos Aires, , Argentina
625-NOVAIN Neurociencias Group
Buenos Aires, , Argentina
603-Fundación para el Estudio y Tratamiento de las Enfermedades Mentales - FETEM
Ciudad Autonoma Buenos Aires, , Argentina
601-CENydET- Centro Neurobiologico y de Estres Traumatico-Biopsychomedical Research Group SRL
Ciudad Autonoma de Buenos Aire, , Argentina
602-FunDamoS
Ciudad Autonoma de Buenos Aire, , Argentina
622-Instituto Medico Damic Srl
Córdoba, , Argentina
624-Centro Especializado en Neurociencias CEN
Córdoba, , Argentina
626-Sanatorio Prof. Leon S. Morra S.A.
Córdoba, , Argentina
617-INSA Instituto de Neurociencias San Agustin S.A.
La Plata, , Argentina
623-Clinica Privada de Salud Mental Santa Teresa de Avila
La Plata, , Argentina
607-Resolution Psicopharmacology Research Institute
Mendoza, , Argentina
454-Mental Health Centre 'Prof. Dr. Ivan Temkov', EOOD
Burgas, , Bulgaria
533-State Psychiatric Hospital - Kardzhali, EOOD
Kardzhali, , Bulgaria
532-MHAT "Dr. Hristo Stambolski", EOOD
Kazanlak, , Bulgaria
569-State Psychiatric Hospital - Lovech
Lovech, , Bulgaria
406-State Psychiatric Hospital - Pazardzhik AD
Pazardzhik, , Bulgaria
535-UMHAT 'Dr. Georgi Stranski', EAD
Pleven, , Bulgaria
586-Medical Center Mentalcare OOD
Plovdiv, , Bulgaria
563-MC-Hipokrat-N E00D
Plovdiv, , Bulgaria
403-University Multiprofile hospital for activated treatment Sveti Georgi, Clinic of psychiatry
Plovdiv, , Bulgaria
592-Medical center Spectar - Plovdiv EOOD
Plovdiv, , Bulgaria
570-Medical Centre "Sveti Naum"
Sofia, , Bulgaria
497-MHC - Sofia, EOOD
Sofia, , Bulgaria
526-DCC "Sv. Vrach and Sv. Sv. Kuzma and Damyan", OOD
Sofia, , Bulgaria
402-Military Medical Academy, Multiprofile Hospital for Actie Treatment - Sofia
Sofia, , Bulgaria
405-UMHAT "Alexandrovska" EAD
Sofia, , Bulgaria
568-Medical Center Hera EOOD
Sofia, , Bulgaria
528-Medical Center Intermedica, OOD
Sofia, , Bulgaria
404-MHAT-Targovishte, AD
Targovishte, , Bulgaria
590-State Psychiatric Hospital - Tzarev Brod
Tsarev Brod, , Bulgaria
498-DCC "Mladost M" - Varna, OOD
Varna, , Bulgaria
455-Mental Health Center - Veliko Tarnovo EOOD
Veliko Tarnovo, , Bulgaria
401-Mental Health Center-Vratsa EOOD
Vratsa, , Bulgaria
Chatham-Kent Clinical Trials Research Ctr
Chatham, Ontario, Canada
351-McGill University Health Ctr Allan Memorial Int.
Montreal, Quebec, Canada
356-Chatham-Kent Clinical Trials Research Ctr
Chatham, , Canada
536 - Clinic for psychiatry Vrapce
Zagreb, , Croatia
537 - Clinic for psychiatry Vrapce
Zagreb, , Croatia
550-Clinic for psychiatry Vrapce
Zagreb, , Croatia
557 - Clinic for psychiatry Vrapce
Zagreb, , Croatia
594-Klinika za psihijatriju Sveti Ivan, n/p Igor Filipčić or Marija Zelenika
Zagreb, , Croatia
512-NeuropsychiatrieHK s.r.o.
Hradec Králové, , Czechia
583-Narodni ustav dusevniho zdravi
Klecany, , Czechia
519-A-SHINE s.r.o.
Pilsen, , Czechia
513-CLINTRIAL s.r.o.
Prague, , Czechia
499-MUDr. Tibor Miklos
Prague, , Czechia
511-Psychiatrie Ricany s.r.o.
Říčany, , Czechia
410-Dr. Máthé és Társa Bt.
Kalocsa, Bács-Kiskun Megye, Hungary
411-ÓBudai Egészségűgyi Centrum Kft
Budapest, Pest County, Hungary
456-Semmelweis University Department of Psychiatry and Psychotherapy
Budapest, Pest County, Hungary
520-Nyiro Gyula Korhaz - Orszagos Pszichiatriai es Addiktologiai Intezet
Budapest, , Hungary
440-PsychoTech Kft.
Pécs, , Hungary
566-Ospedale San Raffaele (San Raffaele Turro)
Milan, , Italy
553-AO Città della Salute e della Scienza di Torino
Torino, , Italy
483-Romuvos klinika, UAB
Kaunas, , Lithuania
518-Kaunas City Outpatient Clinic, Public Institution
Kaunas, , Lithuania
484-Medical Center Puriena JSC
Šilutė, , Lithuania
517-Zirmunai Mental Health Center, Public Institution
Vilnius, , Lithuania
525-Podlaskie Centrum Psychogeriatrii
Bialystok, , Poland
502-Przychodnia Srodmiescie Sp. z o. o.
Bydgoszcz, , Poland
579-Centrum Badan Klinicznych P.I. House Sp. z o.o.
Gdansk, , Poland
501-Specjalistyczna Praktyka Lekarska Marek Domański
Lublin, , Poland
578-MSCZ im. Prof. J. Mazurkiewicza
Pruszków, , Poland
505-GUZ Lipetsk Regional psychoneurological Hospital #1
Plekhanovo, Lipetsk Oblast, Russia
417-State Budget Healthcare Institution of Stavropol Region (Regional Specialized Psychiatric Hospital #2)
Tonnel’nyy, Stavropol Kray, Russia
418-State Budget Healthcare Institution of Arkhangelsk Region "Arkhangelsk Clinical Psychiatric Hospital"
Arkhangelsk, , Russia
459-Federal State Budgetary Research Institution "Mental Health Science Center"
Moscow, , Russia
573-SBIH of Moscow "Psychiatric Clinical Hospital # 4 n.a. P.B. Gannushkin" Short name: PCH N4 n.a. P.B.Gannushkin
Moscow, , Russia
581-SBIH of Moscow "Psych Clinical Hospital #1 N.A. Alekseev"
Moscow, , Russia
419-State municipal healthcare Institution "Leningrad region psychoneurological center"
Saint Petersburg, , Russia
415-Saint-Petersburg State Healthcare Institution "Saint Nicolas Wonderworker Psychiatric Hospital"
Saint Petersburg, , Russia
571-St. Petersburg SHI "Psychoneurological Dispensary #10"
Saint Petersburg, , Russia
451-V. M. Bekhterev National Research Medical Center For Psychiatry and Neurology
Saint Petersburg, , Russia
453-"Saint-Petersburg Scientific Research Psychoneurological Institute n.a. V.M. Bekhterev"
Saint Petersburg, , Russia
465-"Saint-Petersburg Scientific Research Psychoneurological Institute N.A. V.M. Bekhterev"
Saint Petersburg, , Russia
495-FSBI "National Medical Scientifi Center of Psychiatry and Neurology n.a. V.M. Bekhterev" MoH
Saint Petersburg, , Russia
464-Saint Petersburg State Budget Healthcare Institution "City Psychiatric Hospital No. 6 (Inpatient Department with Treatment Center)"
Saint Petersburg, , Russia
443-Saint-Petersburg State Budget Healthcare Institution "Psychoneurological Center #5"
Saint Petersburg, , Russia
444-SPHI "City Mental Hospital #3 n.a. I.I Skvortsov-Stepanov"
Saint Petersburg, , Russia
452-Saint Petersburg State Public Institution of Healthcare "City Psychiatric Hospital #3 n.a.I.I. Skvortsov-Stepanov
Saint Petersburg, , Russia
496-SPHI "City Mental Hospital #3 n.a. I.I Skvortsov-Stepanov
Saint Petersburg, , Russia
458-State Budget Healthcare Institution "Samara Psychiatric Hospital"
Saint Petersburg, , Russia
416-FSBEI HE "Smolensk State Medical University" of the MoH of the RF
Smolensk, , Russia
420-"Podderzhka" Research and Educational Center of Psychotherapy Limited Liability Company
Stavropol, , Russia
572-Klinika StoLet" Ltd.
Tomsk, , Russia
466-OOO "Lion-Med"
Voronezh, , Russia
422-State Budget Healthcare Institution of Yaroslavl Region "Yaroslavl Region Clinical Psychiatric Hospital"
Yaroslavl, , Russia
428-Clinical center of Serbia
Belgrade, , Serbia
424-Institute of Mental health
Belgrade, , Serbia
425-Clinical Hospital Center "Dr. Dragisa Misovic-Dedinje", Clinic of Psychiatry
Belgrade, , Serbia
471-Clinic for Psychiatric Diseases "Dr Laza Lazarevic"
Belgrade, , Serbia
524-General Hospital Euromedik
Belgrade, , Serbia
587-Institute of Mental Health
Belgrade, , Serbia
584-Clinic for Psychiatry, Clinical Canter of Serbia
Belgrade, , Serbia
472-Special Hospital for Psychiatric Diseases "Kovin"
Kovin, , Serbia
493-Special Neuropsychiatric Hospital Kovin
Kovin, , Serbia
423-Clinical Center Kragujevac
Kragujevac, , Serbia
429-Clinical Center Kragujevac, Clinic of Psychiatry
Kragujevac, , Serbia
430-Psychiatric Clinic, Clinical Center Kragujevac
Kragujevac, , Serbia
427-Clinical Center Nis, Clinic of Mental Health
Niš, , Serbia
585-Special Hospital for Psychiatric Diseases "Gornja Toponica"
Niš, , Serbia
593-Specialized Hospital for Neuropsychiatric Diseases "Sveti Vracevi"
Novi Kneževac, , Serbia
476-FIDMAG Germanes Hospitalaries
Barcelona, , Spain
574-Hospital Clinic de Barcelona
Barcelona, , Spain
588-Institucion Hospitalaria Hestia Palau - Ensayos clinicos
Barcelona, , Spain
475-Hospital Gregorio Marañon
Madrid, , Spain
575-Hospital Universitario 12 de Octubre
Madrid, , Spain
494-CSM La Corredoria
Oviedo, , Spain
431-Centro de Salud Parquesol, 2ª planta - Servicio de Psiquiatria
Valladolid, , Spain
529-Hospital Provincial de Zamora
Zamora, , Spain
438-Communal Establishment "Odesa Regional Psychiatric Hospital #2"
Odesa, Oblast, Ukraine
462-Communal Establishment "I.I. Mechnykov Dnipropetrovsk Regional Clinical Hospital"
Dnipro, , Ukraine
510-CI of Kyiv RC Regional Psychiatric-Narcological Medical Association, Depart #10 (male), Dept #2 (female)
Hlevakha, , Ukraine
433-SI "Institute of Neurology, Psychiatry and Narcology of National Academy of Medical Sciences of Ukraine"
Kharkiv, , Ukraine
434-State Institution "Institute of Neurology, Psychiatry and Narcology of NAMS of Ukraine", Department of Urgent Psychiatry and Narcology
Kharkiv, , Ukraine
582-SI Institute of Neurology,Psychiatry&Narcology of NAMSU
Kharkiv, , Ukraine
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
461-Kherson Regional Psychiatric Hospital
Kherson, , Ukraine
507-Main Military Clinical Hospital of MDU
Kyiv, , Ukraine
447-Ukrainian Scientific Research Institute of Social and Forensic Psychiatry and Narcology of Ministry of Healthcare of Ukraine
Kyiv, , Ukraine
Kyiv Regional Medical Incorporation Psychiatry Center of Novel Treatment and Rehabilitation of Psychotic Disorders, Department #29, Department #30
Kyiv, , Ukraine
460-Kyiv City Psychoneurological Hospital #3, General Psychiatry Department No. 2
Kyiv, , Ukraine
435-Kyiv Regional Medical Incorporation "Psychiatry". Center of Novel Treatment and Rehabilitation of Psychotic disorders, build 5, Department #30
Kyiv, , Ukraine
564-Regional Clinical Psychiatric Hospital
Nove, , Ukraine
509-CI Odesa Regional Medical Centre of Mental Health
Odesa, , Ukraine
508-CI Cherkasy Regional Psychiatric Hospital of ChRC Female Dept #11, Male Dept #12
Smila, , Ukraine
591-Municipal non-profit enterprise "Transcarpathian Regional Medical Center of Mental Health and Medicine of Addictions" of the Transcarpathian Regional Council, Department of psychiatry
Uzhhorod, , Ukraine
Communal Establishment "Acad. O.I. Iushchenko Vinnytsia Regional Psychoneurologic Hospital"
Vinnytsia, , Ukraine
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
Vinnytsia, , Ukraine
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2016-003435-38
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
ACP-103-035
Identifier Type: -
Identifier Source: org_study_id
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