Phase
Condition
Mood Disorders
Psychosis
Tourette's Syndrome
Treatment
Pimavanserin
Placebo
Clinical Study ID
Ages 18-55 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Male or female, ≥18 and ≤55 years of age at the time of Screening
Has a caregiver or some other identified responsible person (e.g., family member,social worker, caseworker, or nurse) considered reliable by the Investigator inproviding support to the subject to help ensure compliance with study treatment,study visits, and protocol procedures, and who is also able to provide input helpfulfor completing study rating scales
Diagnosis of schizophrenia made ≥1 year prior to Screening
Is being treated must be one of the antipsychotics listed below:
Aripiprazole
Aripiprazole long-acting injectables
Abilify Maintena®
Aristada®
Asenapine
Brexpiprazole
Cariprazine
Lurasidone
Olanzapine
Paliperidone extended release (ER) (≤9 mg)
Paliperidone palmitate
Invega Sustenna® (≤156 mg)
Invega Trinza® (≤546 mg)
Trevicta® (≤350 mg)
Xeplion® (≤100 mg)
Risperidone
Risperidone long-acting injection
Must be medically stable (including no recent hospitalization for exacerbation ofpsychiatric disorder) and has been medically stable for at least 12 weeks prior toScreening, in the opinion of the Investigator
Exclusion
Exclusion Criteria:
Has a current comorbid psychiatric disorder other than schizophrenia or a disorderthat would interfere with the ability to complete study assessments
Is at a significant risk of suicide, in the opinion of the Investigator
Has a significant risk of violent behavior in the opinion of the Investigator
A confirmed urine drug screen (UDS) result at Baseline that indicates the presenceof any tested prohibited substance of potential abuse, including marijuana
Is taking a medication or drug or other substance that is prohibited according tothis protocol, including medications that prolong the QT interval, strong cytochromeP450 (CYP) 3A4 enzyme (CYP3A4) inhibitors and inducers
Known family or personal history or symptoms of long QT syndrome or risk factors fortorsade de pointes and/or sudden death, including symptomatic bradycardia,hypokalemia or hypomagnesemia, and the presence of congenital prolongation of the QTinterval
Current evidence, or history within the previous 12 weeks prior to Screening, of aserious and/or unstable psychiatric, neurologic, cardiovascular, respiratory,gastrointestinal, renal, hepatic, hematologic, or other medical disorder, includingcancer or malignancies that in the judgment of the Investigator would jeopardize thesafe participation of the subject in the study
Has moderate to severe congestive heart failure
Has a history of myocardial infarction within 6 months prior to enrollment
Has a body mass index (BMI) <19 or ≥35 at Screening
Additional inclusion/exclusion criteria apply. 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 condition do not meet all prespecified entry criteria).
Study Design
Connect with a study center
610-Clinica Privada Banfield S.A.
Buenos Aires,
ArgentinaSite Not Available
601-CENydET- Centro Neurobiologico y de Estres Traumatico-Biopsychomedical Research Group SRL
Ciudad Autonoma Buenos Aires, 1058 AAJ
ArgentinaSite Not Available
602-FunDamoS
Ciudad Autonoma Buenos Aires, C1405BOA
ArgentinaSite Not Available
603-Fundación para el Estudio y Tratamiento de las Enfermedades Mentales - FETEM
Ciudad Autonoma de Buenos Aires, C1133AAH
ArgentinaSite Not Available
625-NOVAIN Neurociencias Group
Ciudad Autonoma de Buenos Aires,
ArgentinaSite Not Available
607-Resolution Psicopharmacology Research Institute
Ciudad de Mendoza, 5502
ArgentinaSite Not Available
624-Centro Especializado en Neurociencias CEN
Cordoba,
ArgentinaSite Not Available
622-Instituto Medico Damic Srl
Córdoba,
ArgentinaSite Not Available
626-Sanatorio Prof. Leon S. Morra S.A.
Córdoba,
ArgentinaSite Not Available
617-INSA Instituto de Neurociencias San Agustin S.A.
La Plata,
ArgentinaSite Not Available
623-Clinica Privada de Salud Mental Santa Teresa de Avila
La Plata,
ArgentinaSite Not Available
532-MHAT "Dr. Hristo Stambolski", EOOD
Kazanlak, Stara Zagora 6100
BulgariaSite Not Available
454-Mental Health Center Prof. Dr. Ivan Temkov - Burgas EO Burgas; Department for Treatment of Emergency Psychiatric Conditions
Burgas, 8000
BulgariaSite Not Available
533-State Psychiatric Hospital - Kardzhali, EOOD
Kardzhali, 6600
BulgariaSite Not Available
569-State Psychiatric Hospital - Lovech
Lovech, 5500
BulgariaSite Not Available
535-UMHAT 'Dr. Georgi Stranski', EAD
Pleven, 5800
BulgariaSite Not Available
563-MC-Hipokrat-N E00D
Plovdiv, 4028
BulgariaSite Not Available
586-Medical Center Mentalcare OOD
Plovdiv, 4004
BulgariaSite Not Available
592-Medical center Spectar - Plovdiv EOOD
Plovdiv,
BulgariaSite Not Available
405-"UMHAT Alexandrovska EAD, Sofia; Clinic of Psychiatry, First Department of Psychiatry "
Sofia, 1431
BulgariaSite Not Available
526-DCC "Sv. Vrach and Sv. Sv. Kuzma and Damyan", OOD
Sofia, 1408
BulgariaSite Not Available
528-Medical Center Intermedica, OOD
Sofia, 1680
BulgariaSite Not Available
568-Medical Center Hera EOOD
Sofia, 1510
BulgariaSite Not Available
570-Medical Centre "Sveti Naum"
Sofia, 1113
BulgariaSite Not Available
404-MHAT-Targovishte Targovishte AD, Targovishte; Department of Psychiatry
Targovishte,
BulgariaSite Not Available
590-State Psychiatric Hospital - Tzarev Brod
Tsarev Brod,
BulgariaSite Not Available
498-DCC "Mladost M" - Varna, OOD
Varna, 9020
BulgariaSite Not Available
455-Mental Health Center - Veliko Tarnovo EOOD,
Veliko Tarnovo, 5000
BulgariaSite Not Available
401-Mental Health Center - Vratsa EOOD, Vratsa; Department of Psychiatry
Vratsa, 3000
BulgariaSite Not Available
536-Clinic for psychiatry Vrapce
Zagreb, 10090
CroatiaSite Not Available
537-Clinic for psychiatry Vrapce
Zagreb, 10090
CroatiaSite Not Available
550-Clinic for psychiatry Vrapce
Zagreb, 10090
CroatiaSite Not Available
557-Clinic for psychiatry Vrapce
Zagreb, 10090
CroatiaSite Not Available
594-klinika za psihijatriju Sveti Ivan, n/p Igor Filipčić or Marija Zelenika
Zagreb,
CroatiaSite Not Available
512-NeuropsychiatrieHK s.r.o.
Hradec Králové, 503 41
CzechiaSite Not Available
583-Narodni ustav dusevniho zdravi
Klecany, 25067
CzechiaSite Not Available
519-A-SHINE s.r.o.
Plzen, 31200
CzechiaSite Not Available
499-MUDr. Tibor Miklos
Praha 10, 106 00
CzechiaSite Not Available
513-CLINTRIAL s.r.o.
Praha 10, 100 00
CzechiaSite Not Available
410-Mathe es Tarsa Bt.
Kalocsa, Bacs 6300
HungarySite Not Available
456-Semmelweis University Department of Psychiatry and Psychotherapy
Budapest, 1083
HungarySite Not Available
520-Nyiro Gyula Korhaz - Orszagos Pszichiatriai es Addiktologiai Intezet
Budapest, 1135
HungarySite Not Available
440-PsychoTech Kft.
Pecs, 7633
HungarySite Not Available
580-AOU Consorziale Policlinico di Bari
Bari,
ItalySite Not Available
552-Ospedale Versilia, UOC Psichiatria
Lido Di Camaiore,
ItalySite Not Available
539-"Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico U.O.C. Psichiatria - Padiglione Alfieri, primo piano"
Milano, 20122
ItalySite Not Available
566-Ospedale San Raffaele (San Raffaele Turro)
Milano, 20127
ItalySite Not Available
577-ASST di Monza (Presidio San Gerardo)
Monza,
ItalySite Not Available
553-AO Città della Salute e della Scienza di Torino
Torino,
ItalySite Not Available
483-Romuvos klinika, UAB
Kaunas, LT-44279
LithuaniaSite Not Available
516-Neuromeda, JSC
Kaunas, 50185
LithuaniaSite Not Available
518-Kaunas City Outpatient Clinic, Public Institution
Kaunas, LT-48259
LithuaniaSite Not Available
484-Medical Center Puriena JSC
Silute,
LithuaniaSite Not Available
N/A-Silutes Mental Health and Psychotherapy Center, JSC
Silute, 99142
LithuaniaSite Not Available
525-Podlaskie Centrum Psychogeriatrii
Bialystok, 15-756
PolandSite Not Available
442-Clinsante S.C. Osrodek Badan Klinicznych
Bydgoszcz,
PolandSite Not Available
502-Przychodnia Srodmiescie Sp. z o. o.
Bydgoszcz, 85-080
PolandSite Not Available
579-Centrum Badan Klinicznych P.I. House Sp. z o.o.
Gdańsk, 80-546
PolandSite Not Available
541-Care Clinic centrum Medyczne
Katowice, 40-568
PolandSite Not Available
501-Specjalistyczna Praktyka Lekarska Marek Domański
Lublin, 20-582
PolandSite Not Available
578-MSCZ im. prof. J. Mazurkiewicza
Pruszków, 05-802
PolandSite Not Available
540-Ośr. Badań Klin. CLINSANTE S.C.
Torun, 87-100
PolandSite Not Available
417-State budget healthcare Institution of Stavropol region "Regional specialized psychiatric hospital #2".
Tonnel'nyy, Stavropol Region 357034
Russian FederationSite Not Available
505-GUZ Lipetsk Regional psychoneurological Hospital #1
Lipetsk, 398007
Russian FederationSite Not Available
573-"SBIH of Moscow ""Psychiatric Clinical Hospital # 4 n.a. P.B. Gannushkin"" Short name: PCH N4 n.a. P.B.Gannushkin"
Moscow, 107076
Russian FederationSite Not Available
581-SBIH of Moscow "Psych Clinical Hospital #1 N.A. Alekseev"
Moscow, 117152
Russian FederationSite Not Available
415-Saint-Petersburg state healthcare institution "Saint Nicolas wonderworker psychiatric hospital"
Saint Petersburg, 190121
Russian FederationSite Not Available
443-SBHI "Psychoneurological Dispensary #5"
Saint Petersburg,
Russian FederationSite Not Available
451-V. M. Bekhterev National Research Medical Center For Psychiatry and Neurology
Saint Petersburg, 192019
Russian FederationSite Not Available
452-Saint Petersburg State Public Institution of Healthcare "City Psychiatric Hospital #3 n.a. I. I. Skvortsov-Stepanov",
Saint Petersburg, 197341
Russian FederationSite Not Available
464-Saint Petersburg State Budget Healthcare Institution "City Psychiatric Hospital No. 6 (Inpatient Department with Treatment Center)
Saint Petersburg, 193167
Russian FederationSite Not Available
465-"Saint-Petersburg Scientific Research Psychoneurological Institute n.a. V.M. Bekhterev
Saint Petersburg, 192019
Russian FederationSite Not Available
495-"FSBI "National medical scientific center of psychiatry and neurology n.a. V.M. Bekhterev" MoH Short name: NMSC of Psy&Neuro n.a. Bekhterev, 12 dep."
Saint Petersburg, 192019
Russian FederationSite Not Available
444-SPHI "City Mental Hospital #3 n.a. I.I.Skvortsov-Stepanov"
Saint-Petersburg, 197341
Russian FederationSite Not Available
453-"Saint-Petersburg Scientific Research Psychoneurological Institute n.a. V.M. Bekhterev"
Saint-Petersburg, 192019
Russian FederationSite Not Available
496-SPHI "City Mental Hospital #3 n.a. I.I.Skvortsov-Stepanov"
Saint-Petersburg, 197341
Russian FederationSite Not Available
571-St. Petersburg SHI "Psychoneurological Dispensary #10"
Saint-Petersburg, 190121
Russian FederationSite Not Available
458-State Budget Healthcare Institution "Samara Psychiatric Hospital
Samara, 443016
Russian FederationSite Not Available
416-FSBEI HE "Smolensk State Medical University" of the MoH of the RF (Clinical Research Centre of diagnostics and medicines)
Smolensk, 214019
Russian FederationSite Not Available
443-SBHI "Psychoneurological Dispensary #5"
St. Petersburg,
Russian FederationSite Not Available
572-Klinika StoLet" Ltd.
Tomsk, 634009
Russian FederationSite Not Available
422-State Budget healthcare Institution of Yaroslavl region "Yaroslavl region clinical psychiatric hospital"
Yaroslavl, 150003
Russian FederationSite Not Available
424-Institute of Mental health
Belgrade, 11000
SerbiaSite Not Available
425-Clinical Hospital Center "Dr. Dragisa Misovic-Dedinje", Clinic of Psychiatry
Belgrade, 11000
SerbiaSite Not Available
584-Clinic for Psychiatry, Clinical Canter of Serbia
Belgrade,
SerbiaSite Not Available
587-Institute of Mental health
Belgrade,
SerbiaSite Not Available
472-Special Neuropsychiatric Hospital Kovin
Kovin,
SerbiaSite Not Available
423-Clinical Center Kragujevac, Clinic of Psychiatry
Kragujevac,
SerbiaSite Not Available
430-Psychiatric Clinic, Clinical Center Kragujevac
Kragujevac, 34000
SerbiaSite Not Available
427-Clinical Center Nis, Mental Health Protection Clinic
Nis, 18000
SerbiaSite Not Available
585-Special Hospital for Psychiatric Diseases "Gornja Toponica"
Niš,
SerbiaSite Not Available
593-Specialized Hospital for Neuropsychiatric Diseases "Sveti Vracevi"
Novi Kneževac,
SerbiaSite Not Available
574-Hospital Clinic de Barcelona
Barcelona, 08036
SpainSite Not Available
576-Hospital Universitari Vall d'Hebron
Barcelona, 8035
SpainSite Not Available
588-Institucion Hospitalaria Hestia Palau - Ensayos clinicos
Barcelona,
SpainSite Not Available
475-Hospital Gregorio Marañon
Madrid, 28007
SpainSite Not Available
575-Hospital Universitario 12 de Octubre
Madrid, 28041
SpainSite Not Available
494-CSM La Corredoria
Oviedo, 33011
SpainSite Not Available
431-Centro de Salud Parquesol, 2ª planta - Servicio de Psiquiatria
Valladolid, 47016
SpainActive - Recruiting
431-Hospital Psiquiátrico Provincial Doctor Villacian
Valladolid, 47016
SpainSite Not Available
529-Hospital Provincial de Zamora
Zamora, 49021
SpainSite Not Available
508-CI Cherkasy Regional Psychiatric Hospital of ChRC
Smila, Cherkas'ka Oblast 20708
UkraineSite Not Available
564-Regional Clinical Psychiatric Hospital
Kropyvnytskyi, Kirovograd Region 25491
UkraineSite Not Available
Kyiv City Psychoneurological Hospital #3 General Psychiatry Department No. 2
Glevakha Town, Vasylkiv District Kyiv Region 8631
UkraineSite Not Available
460-Kyiv City Psychoneurological Hospital #3 General Psychiatry Department No. 2
Kyiv, Vasylkiv District Kyiv Region 08631
UkraineSite Not Available
Kyiv City Psychoneurological Hospital #3 General Psychiatry Department No. 2
v.Glevakha, Vasylkiv District Kyiv Region 08631
UkraineSite Not Available
434-State Institution "Institute of Neurology, Psychiatry and Narcology of NAMS of Ukraine", Department of Urgent Psychiatry and Narcology
Kharkiv, 61068
UkraineSite Not Available
567-"CIH Kharkiv Regional Clinical Psychiatric Hospital #3 Psychiatric Department of Primary Psychotic Episod Short Site name: CIH KRCPH #3 PD of PPE "
Kharkiv, 61068
UkraineSite Not Available
582-SI Institute of Neurology,Psychiatry&Narcology of NAMSU
Kharkiv, 61068
UkraineSite Not Available
435-Kyiv Regional Medical Incorporation "Psychiatry". Center of Novel Treatment and Rehabilitation of Psychotic disorders, build 5, Department #30
Kyiv, 04080
UkraineSite Not Available
447-Department of Medical Social Issues in Treatment of Mental Disorder of the Ukrainian Scientific Research Institute of Social and Forensic Psychiatry and Narcology of the Ministry of Health of Ukraine, Outpatient Multidisciplinary Consultation Clinic
Kyiv,
UkraineSite Not Available
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, 3049
UkraineSite Not Available
509-CI Odesa Regional Medical Centre of Mental Health
Odesa, 65014
UkraineSite Not Available
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,
UkraineSite Not Available
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