Extension Study of Pimavanserin for the Adjunctive Treatment of Schizophrenia
- Registration Number
- NCT03121586
- Lead Sponsor
- ACADIA Pharmaceuticals Inc.
- Brief Summary
To evaluate the long-term safety and tolerability of pimavanserin after 52 weeks of adjunctive treatment in subjects with schizophrenia
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 996
-
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
-
-
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Drug - Pimavanserin Pimavanserin Pimavanserin 34 mg, 20 mg, or 10 mg, + background antipsychotic, taken once daily by mouth
- Primary Outcome Measures
Name Time Method Evaluate the long-term safety and tolerability of pimavanserin (e.g., Summary of Treatment-Emergent Adverse Events [Safety and Tolerability]) 52 weeks Evaluate the long-term safety and tolerability of pimavanserin after 52 weeks of adjunctive treatment in subjects with schizophrenia
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (161)
141-Hassman Research Institute
🇺🇸Berlin, New Jersey, United States
114-Northwestern University
🇺🇸Chicago, Illinois, United States
582-SI Institute of Neurology,Psychiatry&Narcology of NAMSU
🇺🇦Kharkiv, Ukraine
510-CI of Kyiv RC Regional Psychiatric-Narcological Medical Association, Depart #10 (male), Dept #2 (female)
🇺🇦Hlevakha, Ukraine
164-Artemis Institute for Clinical Research
🇺🇸San Diego, California, United States
124-Altea Research Institute
🇺🇸Las Vegas, Nevada, United States
165-CITrials
🇺🇸Santa Ana, California, United States
101-American Medical Research
🇺🇸Chicago, Illinois, United States
170-Suburban Research Associates
🇺🇸Downingtown, Pennsylvania, United States
168-Atlanta Center for Medical Research
🇺🇸Atlanta, Georgia, United States
622-Instituto Medico Damic Srl
🇦🇷Córdoba, Argentina
137-Innovative Clinical Research, Inc.
🇺🇸Lauderhill, Florida, United States
146-Premier Clinical Research Institute, Inc.
🇺🇸Miami, Florida, United States
156-Woodland International Research Group, LLC
🇺🇸Little Rock, Arkansas, United States
105-ProScience Research Group
🇺🇸Culver City, California, United States
593-Specialized Hospital for Neuropsychiatric Diseases "Sveti Vracevi"
🇷🇸Novi Kneževac, Serbia
517-Zirmunai Mental Health Center, Public Institution
🇱🇹Vilnius, Lithuania
424-Institute of Mental health
🇷🇸Belgrad, Serbia
518-Kaunas City Outpatient Clinic, Public Institution
🇱🇹Kaunas, Lithuania
484-Medical Center Puriena JSC
🇱🇹Silute, Lithuania
425-Clinical Hospital Center "Dr. Dragisa Misovic-Dedinje", Clinic of Psychiatry
🇷🇸Belgrade, Serbia
471-Clinic for Psychiatric Diseases "Dr Laza Lazarevic"
🇷🇸Belgrade, Serbia
493-Special Neuropsychiatric Hospital Kovin
🇷🇸Kovin, Serbia
429-Clinical Center Kragujevac, Clinic of Psychiatry
🇷🇸Kragujevac, Serbia
587-Institute of Mental Health
🇷🇸Belgrad, Serbia
483-Romuvos klinika, UAB
🇱🇹Kaunas, Lithuania
423-Clinical Center Kragujevac
🇷🇸Kragujevac, Serbia
430-Psychiatric Clinic, Clinical Center Kragujevac
🇷🇸Kragujevac, Serbia
171-Alea Research Institute
🇺🇸Phoenix, Arizona, United States
145-Carolina Behavioral Care
🇺🇸Durham, North Carolina, United States
115-Psychiatric and Behavioral Solutions LLC
🇺🇸Salt Lake City, Utah, United States
356-Chatham-Kent Clinical Trials Research Ctr
🇨🇦Chatham, Canada
459-Federal State Budgetary Research Institution "Mental Health Science Center"
🇷🇺Moscow, Russian Federation
496-SPHI "City Mental Hospital #3 n.a. I.I Skvortsov-Stepanov
🇷🇺Saint Petersburg, Russian Federation
403-University Multiprofile hospital for activated treatment Sveti Georgi, Clinic of psychiatry
🇧🇬Plovdiv, Bulgaria
106-New Hope Clinical Research
🇺🇸Charlotte, North Carolina, United States
123-Synergy San Diego
🇺🇸Lemon Grove, California, United States
570-Medical Centre "Sveti Naum"
🇧🇬Sofia, Bulgaria
592-Medical center Spectar - Plovdiv EOOD
🇧🇬Plovdiv, Bulgaria
111-Woodland Research Northwest, LLC
🇺🇸Rogers, Arkansas, United States
167-CITrials - Bellflower
🇺🇸Bellflower, California, United States
108-Collaborative Nueroscience Network, LLC
🇺🇸Torrance, California, United States
125-Galiz Research
🇺🇸Hialeah, Florida, United States
162-Synexus Clinical Research, Inc.
🇺🇸Atlanta, Georgia, United States
102-Northwest Behavioral Research Center
🇺🇸Marietta, Georgia, United States
130-Alexian Brothers Center for Psychiatric Research
🇺🇸Hoffman Estates, Illinois, United States
118-Lake Charles Clinical Trials
🇺🇸Lake Charles, Louisiana, United States
153-Albuquerque Neuroscience Inc.
🇺🇸Albuquerque, New Mexico, United States
140-Synexus Clinical Research, Inc - 140
🇺🇸Jamaica, New York, United States
104-Neurobehavioral Research, Inc.
🇺🇸Cedarhurst, New York, United States
110-Cutting Edge Research Group
🇺🇸Oklahoma City, Oklahoma, United States
128-Finger Lakes Clinical Research
🇺🇸Rochester, New York, United States
103-Pillar Clinical Research, LLC
🇺🇸Richardson, Texas, United States
127-University Hills Clinical Research
🇺🇸Irving, Texas, United States
610-Clinica Privada Banfield S.A.
🇦🇷Buenos Aires, Argentina
603-Fundación para el Estudio y Tratamiento de las Enfermedades Mentales - FETEM
🇦🇷Ciudad Autonoma Buenos Aires, Argentina
625-NOVAIN Neurociencias Group
🇦🇷Ciudad Autonoma de Buenos Aires, Argentina
601-CENydET- Centro Neurobiologico y de Estres Traumatico-Biopsychomedical Research Group SRL
🇦🇷Ciudad Autonoma de Buenos Aire, Argentina
498-DCC "Mladost M" - Varna, OOD
🇧🇬Varna, Bulgaria
602-FunDamoS
🇦🇷Ciudad Autonoma de Buenos Aire, Argentina
626-Sanatorio Prof. Leon S. Morra S.A.
🇦🇷Cordoba, Argentina
607-Resolution Psicopharmacology Research Institute
🇦🇷Ciudad de Mendoza, Argentina
624-Centro Especializado en Neurociencias CEN
🇦🇷Córdoba, Argentina
617-INSA Instituto de Neurociencias San Agustin S.A.
🇦🇷La Plata, Argentina
454-Mental Health Centre 'Prof. Dr. Ivan Temkov', EOOD
🇧🇬Burgas, Bulgaria
623-Clinica Privada de Salud Mental Santa Teresa de Avila
🇦🇷La Plata, Argentina
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
563-MC-Hipokrat-N E00D
🇧🇬Plovdiv, 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
586-Medical Center Mentalcare OOD
🇧🇬Plovdiv, Bulgaria
568-Medical Center Hera EOOD
🇧🇬Sofia, Bulgaria
528-Medical Center Intermedica, OOD
🇧🇬Sofia, Bulgaria
590-State Psychiatric Hospital - Tzarev Brod
🇧🇬Tsarev Brod, Bulgaria
404-MHAT-Targovishte, AD
🇧🇬Targovishte, 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.
🇨🇦Montréal, Quebec, Canada
550-Clinic for psychiatry Vrapce
🇭🇷Zagreb, Croatia
557 - Clinic for psychiatry Vrapce
🇭🇷Zagreb, Croatia
519-A-SHINE s.r.o.
🇨🇿Plzen, Czechia
594-Klinika za psihijatriju Sveti Ivan, n/p Igor Filipčić or Marija Zelenika
🇭🇷Zagreb, Croatia
583-Narodni ustav dusevniho zdravi
🇨🇿Klecany, Czechia
512-NeuropsychiatrieHK s.r.o.
🇨🇿Hradec Králové, Czechia
511-Psychiatrie Ricany s.r.o.
🇨🇿Říčany, Czechia
513-CLINTRIAL s.r.o.
🇨🇿Praha 10, Czechia
525-Podlaskie Centrum Psychogeriatrii
🇵🇱Białystok, Poland
499-MUDr. Tibor Miklos
🇨🇿Praha 10, Czechia
410-Dr. Máthé és Társa Bt.
🇭🇺Kalocsa, Bács-Kiskun Megye, Hungary
456-Semmelweis University Department of Psychiatry and Psychotherapy
🇭🇺Budapest, Pest Megye, Hungary
520-Nyiro Gyula Korhaz - Orszagos Pszichiatriai es Addiktologiai Intezet
🇭🇺Budapest, Hungary
411-ÓBudai Egészségűgyi Centrum Kft
🇭🇺Budapest, Pest Megye, Hungary
440-PsychoTech Kft.
🇭🇺Pécs, Hungary
566-Ospedale San Raffaele (San Raffaele Turro)
🇮🇹Milano, Italy
553-AO Città della Salute e della Scienza di Torino
🇮🇹Torino, Italy
579-Centrum Badan Klinicznych P.I. House Sp. z o.o.
🇵🇱Gdańsk, Poland
502-Przychodnia Srodmiescie Sp. z o. o.
🇵🇱Bydgoszcz, Poland
501-Specjalistyczna Praktyka Lekarska Marek Domański
🇵🇱Lublin, Poland
578-MSCZ im. Prof. J. Mazurkiewicza
🇵🇱Pruszków, Poland
417-State Budget Healthcare Institution of Stavropol Region (Regional Specialized Psychiatric Hospital #2)
🇷🇺Tonnel'nyy, Stavropol Region, Russian Federation
505-GUZ Lipetsk Regional psychoneurological Hospital #1
🇷🇺Plekhanovo, Lipetsk Region, Russian Federation
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
418-State Budget Healthcare Institution of Arkhangelsk Region "Arkhangelsk Clinical Psychiatric Hospital"
🇷🇺Arkhangel'sk, Russian Federation
419-State municipal healthcare Institution "Leningrad region psychoneurological center"
🇷🇺Leningrad, Russian Federation
581-SBIH of Moscow "Psych Clinical Hospital #1 N.A. Alekseev"
🇷🇺Moscow, Russian Federation
451-V. M. Bekhterev National Research Medical Center For Psychiatry and Neurology
🇷🇺Saint Petersburg, Russian Federation
415-Saint-Petersburg State Healthcare Institution "Saint Nicolas Wonderworker Psychiatric Hospital"
🇷🇺Saint Petersburg, Russian Federation
453-"Saint-Petersburg Scientific Research Psychoneurological Institute n.a. V.M. Bekhterev"
🇷🇺Saint Petersburg, Russian Federation
465-"Saint-Petersburg Scientific Research Psychoneurological Institute N.A. V.M. Bekhterev"
🇷🇺Saint Petersburg, Russian Federation
495-FSBI "National Medical Scientifi Center of Psychiatry and Neurology n.a. V.M. Bekhterev" MoH
🇷🇺Saint Petersburg, Russian Federation
443-Saint-Petersburg State Budget Healthcare Institution "Psychoneurological Center #5"
🇷🇺Saint Petersburg, Russian Federation
444-SPHI "City Mental Hospital #3 n.a. I.I Skvortsov-Stepanov"
🇷🇺Saint Petersburg, Russian Federation
452-Saint Petersburg State Public Institution of Healthcare "City Psychiatric Hospital #3 n.a.I.I. Skvortsov-Stepanov
🇷🇺Saint Petersburg, Russian Federation
458-State Budget Healthcare Institution "Samara Psychiatric Hospital"
🇷🇺Saint Petersburg, Russian Federation
571-St. Petersburg SHI "Psychoneurological Dispensary #10"
🇷🇺Saint-Petersburg, Russian Federation
416-FSBEI HE "Smolensk State Medical University" of the MoH of the RF
🇷🇺Smolensk, Russian Federation
428-Clinical center of Serbia
🇷🇸Belgrade, Serbia
464-Saint Petersburg State Budget Healthcare Institution "City Psychiatric Hospital No. 6 (Inpatient Department with Treatment Center)"
🇷🇺Saint-Petersburg, Russian Federation
420-"Podderzhka" Research and Educational Center of Psychotherapy Limited Liability Company
🇷🇺Stavropol', Russian Federation
572-Klinika StoLet" Ltd.
🇷🇺Tomsk, Russian Federation
466-OOO "Lion-Med"
🇷🇺Voronezh, Russian Federation
422-State Budget Healthcare Institution of Yaroslavl Region "Yaroslavl Region Clinical Psychiatric Hospital"
🇷🇺Yaroslavl, Russian Federation
524-General Hospital Euromedik
🇷🇸Belgrade, Serbia
584-Clinic for Psychiatry, Clinical Canter of Serbia
🇷🇸Belgrad, Serbia
472-Special Hospital for Psychiatric Diseases "Kovin"
🇷🇸Kovin, Serbia
427-Clinical Center Nis, Clinic of Mental Health
🇷🇸Nis, Serbia
585-Special Hospital for Psychiatric Diseases "Gornja Toponica"
🇷🇸Niš, Serbia
574-Hospital Clinic de Barcelona
🇪🇸Barcelona, Spain
476-FIDMAG Germanes Hospitalaries
🇪🇸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
431-Centro de Salud Parquesol, 2ª planta - Servicio de Psiquiatria
🇪🇸Valladolid, Spain
494-CSM La Corredoria
🇪🇸Oviedo, Spain
438-Communal Establishment "Odesa Regional Psychiatric Hospital #2"
🇺🇦Odessa, Oblast, Ukraine
529-Hospital Provincial de Zamora
🇪🇸Zamora, Spain
462-Communal Establishment "I.I. Mechnykov Dnipropetrovsk Regional Clinical Hospital"
🇺🇦Dnipro, Ukraine
434-State Institution "Institute of Neurology, Psychiatry and Narcology of NAMS of Ukraine", Department of Urgent Psychiatry and Narcology
🇺🇦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
564-Regional Clinical Psychiatric Hospital
🇺🇦Nove, Ukraine
460-Kyiv City Psychoneurological Hospital #3, General Psychiatry Department No. 2
🇺🇦Kyiv, Ukraine
509-CI Odesa Regional Medical Centre of Mental Health
🇺🇦Odesa, 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
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
🇺🇦Úzhgorod, Ukraine
537 - Clinic for psychiatry Vrapce
🇭🇷Zagreb, Croatia
536 - Clinic for psychiatry Vrapce
🇭🇷Zagreb, Croatia
433-SI "Institute of Neurology, Psychiatry and Narcology of National Academy of Medical Sciences of Ukraine"
🇺🇦Kharkiv, Ukraine
435-Kyiv Regional Medical Incorporation "Psychiatry". Center of Novel Treatment and Rehabilitation of Psychotic disorders, build 5, Department #30
🇺🇦Kyiv, 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