Efficacy and Safety of Pimavanserin as Adjunctive Treatment for the Negative Symptoms of Schizophrenia

Last updated: March 31, 2025
Sponsor: ACADIA Pharmaceuticals Inc.
Overall Status: Completed

Phase

3

Condition

Mood Disorders

Psychosis

Tourette's Syndrome

Treatment

Pimavanserin

Placebo

Clinical Study ID

NCT04531982
ACP-103-064
  • Ages 18-55
  • All Genders

Study Summary

To evaluate the efficacy and safety of adjunctive pimavanserin compared with adjunctive placebo in the treatment of negative symptoms of schizophrenia

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

Total Participants: 454
Treatment Group(s): 2
Primary Treatment: Pimavanserin
Phase: 3
Study Start date:
August 05, 2020
Estimated Completion Date:
February 19, 2024

Connect with a study center

  • 610-Clinica Privada Banfield S.A.

    Buenos Aires,
    Argentina

    Site Not Available

  • 601-CENydET- Centro Neurobiologico y de Estres Traumatico-Biopsychomedical Research Group SRL

    Ciudad Autonoma Buenos Aires, 1058 AAJ
    Argentina

    Site Not Available

  • 602-FunDamoS

    Ciudad Autonoma Buenos Aires, C1405BOA
    Argentina

    Site Not Available

  • 603-Fundación para el Estudio y Tratamiento de las Enfermedades Mentales - FETEM

    Ciudad Autonoma de Buenos Aires, C1133AAH
    Argentina

    Site Not Available

  • 625-NOVAIN Neurociencias Group

    Ciudad Autonoma de Buenos Aires,
    Argentina

    Site Not Available

  • 607-Resolution Psicopharmacology Research Institute

    Ciudad de Mendoza, 5502
    Argentina

    Site Not Available

  • 624-Centro Especializado en Neurociencias CEN

    Cordoba,
    Argentina

    Site Not Available

  • 622-Instituto Medico Damic Srl

    Córdoba,
    Argentina

    Site Not Available

  • 626-Sanatorio Prof. Leon S. Morra S.A.

    Córdoba,
    Argentina

    Site Not Available

  • 617-INSA Instituto de Neurociencias San Agustin S.A.

    La Plata,
    Argentina

    Site Not Available

  • 623-Clinica Privada de Salud Mental Santa Teresa de Avila

    La Plata,
    Argentina

    Site Not Available

  • 532-MHAT "Dr. Hristo Stambolski", EOOD

    Kazanlak, Stara Zagora 6100
    Bulgaria

    Site Not Available

  • 454-Mental Health Center Prof. Dr. Ivan Temkov - Burgas EO Burgas; Department for Treatment of Emergency Psychiatric Conditions

    Burgas, 8000
    Bulgaria

    Site Not Available

  • 533-State Psychiatric Hospital - Kardzhali, EOOD

    Kardzhali, 6600
    Bulgaria

    Site Not Available

  • 569-State Psychiatric Hospital - Lovech

    Lovech, 5500
    Bulgaria

    Site Not Available

  • 535-UMHAT 'Dr. Georgi Stranski', EAD

    Pleven, 5800
    Bulgaria

    Site Not Available

  • 563-MC-Hipokrat-N E00D

    Plovdiv, 4028
    Bulgaria

    Site Not Available

  • 586-Medical Center Mentalcare OOD

    Plovdiv, 4004
    Bulgaria

    Site Not Available

  • 592-Medical center Spectar - Plovdiv EOOD

    Plovdiv,
    Bulgaria

    Site Not Available

  • 405-"UMHAT Alexandrovska EAD, Sofia; Clinic of Psychiatry, First Department of Psychiatry "

    Sofia, 1431
    Bulgaria

    Site Not Available

  • 526-DCC "Sv. Vrach and Sv. Sv. Kuzma and Damyan", OOD

    Sofia, 1408
    Bulgaria

    Site Not Available

  • 528-Medical Center Intermedica, OOD

    Sofia, 1680
    Bulgaria

    Site Not Available

  • 568-Medical Center Hera EOOD

    Sofia, 1510
    Bulgaria

    Site Not Available

  • 570-Medical Centre "Sveti Naum"

    Sofia, 1113
    Bulgaria

    Site Not Available

  • 404-MHAT-Targovishte Targovishte AD, Targovishte; Department of Psychiatry

    Targovishte,
    Bulgaria

    Site Not Available

  • 590-State Psychiatric Hospital - Tzarev Brod

    Tsarev Brod,
    Bulgaria

    Site Not Available

  • 498-DCC "Mladost M" - Varna, OOD

    Varna, 9020
    Bulgaria

    Site Not Available

  • 455-Mental Health Center - Veliko Tarnovo EOOD,

    Veliko Tarnovo, 5000
    Bulgaria

    Site Not Available

  • 401-Mental Health Center - Vratsa EOOD, Vratsa; Department of Psychiatry

    Vratsa, 3000
    Bulgaria

    Site Not Available

  • 536-Clinic for psychiatry Vrapce

    Zagreb, 10090
    Croatia

    Site Not Available

  • 537-Clinic for psychiatry Vrapce

    Zagreb, 10090
    Croatia

    Site Not Available

  • 550-Clinic for psychiatry Vrapce

    Zagreb, 10090
    Croatia

    Site Not Available

  • 557-Clinic for psychiatry Vrapce

    Zagreb, 10090
    Croatia

    Site Not Available

  • 594-klinika za psihijatriju Sveti Ivan, n/p Igor Filipčić or Marija Zelenika

    Zagreb,
    Croatia

    Site Not Available

  • 512-NeuropsychiatrieHK s.r.o.

    Hradec Králové, 503 41
    Czechia

    Site Not Available

  • 583-Narodni ustav dusevniho zdravi

    Klecany, 25067
    Czechia

    Site Not Available

  • 519-A-SHINE s.r.o.

    Plzen, 31200
    Czechia

    Site Not Available

  • 499-MUDr. Tibor Miklos

    Praha 10, 106 00
    Czechia

    Site Not Available

  • 513-CLINTRIAL s.r.o.

    Praha 10, 100 00
    Czechia

    Site Not Available

  • 410-Mathe es Tarsa Bt.

    Kalocsa, Bacs 6300
    Hungary

    Site Not Available

  • 456-Semmelweis University Department of Psychiatry and Psychotherapy

    Budapest, 1083
    Hungary

    Site Not Available

  • 520-Nyiro Gyula Korhaz - Orszagos Pszichiatriai es Addiktologiai Intezet

    Budapest, 1135
    Hungary

    Site Not Available

  • 440-PsychoTech Kft.

    Pecs, 7633
    Hungary

    Site Not Available

  • 580-AOU Consorziale Policlinico di Bari

    Bari,
    Italy

    Site Not Available

  • 552-Ospedale Versilia, UOC Psichiatria

    Lido Di Camaiore,
    Italy

    Site Not Available

  • 539-"Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico U.O.C. Psichiatria - Padiglione Alfieri, primo piano"

    Milano, 20122
    Italy

    Site Not Available

  • 566-Ospedale San Raffaele (San Raffaele Turro)

    Milano, 20127
    Italy

    Site Not Available

  • 577-ASST di Monza (Presidio San Gerardo)

    Monza,
    Italy

    Site Not Available

  • 553-AO Città della Salute e della Scienza di Torino

    Torino,
    Italy

    Site Not Available

  • 483-Romuvos klinika, UAB

    Kaunas, LT-44279
    Lithuania

    Site Not Available

  • 516-Neuromeda, JSC

    Kaunas, 50185
    Lithuania

    Site Not Available

  • 518-Kaunas City Outpatient Clinic, Public Institution

    Kaunas, LT-48259
    Lithuania

    Site Not Available

  • 484-Medical Center Puriena JSC

    Silute,
    Lithuania

    Site Not Available

  • N/A-Silutes Mental Health and Psychotherapy Center, JSC

    Silute, 99142
    Lithuania

    Site Not Available

  • 525-Podlaskie Centrum Psychogeriatrii

    Bialystok, 15-756
    Poland

    Site Not Available

  • 442-Clinsante S.C. Osrodek Badan Klinicznych

    Bydgoszcz,
    Poland

    Site Not Available

  • 502-Przychodnia Srodmiescie Sp. z o. o.

    Bydgoszcz, 85-080
    Poland

    Site Not Available

  • 579-Centrum Badan Klinicznych P.I. House Sp. z o.o.

    Gdańsk, 80-546
    Poland

    Site Not Available

  • 541-Care Clinic centrum Medyczne

    Katowice, 40-568
    Poland

    Site Not Available

  • 501-Specjalistyczna Praktyka Lekarska Marek Domański

    Lublin, 20-582
    Poland

    Site Not Available

  • 578-MSCZ im. prof. J. Mazurkiewicza

    Pruszków, 05-802
    Poland

    Site Not Available

  • 540-Ośr. Badań Klin. CLINSANTE S.C.

    Torun, 87-100
    Poland

    Site Not Available

  • 417-State budget healthcare Institution of Stavropol region "Regional specialized psychiatric hospital #2".

    Tonnel'nyy, Stavropol Region 357034
    Russian Federation

    Site Not Available

  • 505-GUZ Lipetsk Regional psychoneurological Hospital #1

    Lipetsk, 398007
    Russian Federation

    Site 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 Federation

    Site Not Available

  • 581-SBIH of Moscow "Psych Clinical Hospital #1 N.A. Alekseev"

    Moscow, 117152
    Russian Federation

    Site Not Available

  • 415-Saint-Petersburg state healthcare institution "Saint Nicolas wonderworker psychiatric hospital"

    Saint Petersburg, 190121
    Russian Federation

    Site Not Available

  • 443-SBHI "Psychoneurological Dispensary #5"

    Saint Petersburg,
    Russian Federation

    Site Not Available

  • 451-V. M. Bekhterev National Research Medical Center For Psychiatry and Neurology

    Saint Petersburg, 192019
    Russian Federation

    Site Not Available

  • 452-Saint Petersburg State Public Institution of Healthcare "City Psychiatric Hospital #3 n.a. I. I. Skvortsov-Stepanov",

    Saint Petersburg, 197341
    Russian Federation

    Site Not Available

  • 464-Saint Petersburg State Budget Healthcare Institution "City Psychiatric Hospital No. 6 (Inpatient Department with Treatment Center)

    Saint Petersburg, 193167
    Russian Federation

    Site Not Available

  • 465-"Saint-Petersburg Scientific Research Psychoneurological Institute n.a. V.M. Bekhterev

    Saint Petersburg, 192019
    Russian Federation

    Site 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 Federation

    Site Not Available

  • 444-SPHI "City Mental Hospital #3 n.a. I.I.Skvortsov-Stepanov"

    Saint-Petersburg, 197341
    Russian Federation

    Site Not Available

  • 453-"Saint-Petersburg Scientific Research Psychoneurological Institute n.a. V.M. Bekhterev"

    Saint-Petersburg, 192019
    Russian Federation

    Site Not Available

  • 496-SPHI "City Mental Hospital #3 n.a. I.I.Skvortsov-Stepanov"

    Saint-Petersburg, 197341
    Russian Federation

    Site Not Available

  • 571-St. Petersburg SHI "Psychoneurological Dispensary #10"

    Saint-Petersburg, 190121
    Russian Federation

    Site Not Available

  • 458-State Budget Healthcare Institution "Samara Psychiatric Hospital

    Samara, 443016
    Russian Federation

    Site 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 Federation

    Site Not Available

  • 443-SBHI "Psychoneurological Dispensary #5"

    St. Petersburg,
    Russian Federation

    Site Not Available

  • 572-Klinika StoLet" Ltd.

    Tomsk, 634009
    Russian Federation

    Site Not Available

  • 422-State Budget healthcare Institution of Yaroslavl region "Yaroslavl region clinical psychiatric hospital"

    Yaroslavl, 150003
    Russian Federation

    Site Not Available

  • 424-Institute of Mental health

    Belgrade, 11000
    Serbia

    Site Not Available

  • 425-Clinical Hospital Center "Dr. Dragisa Misovic-Dedinje", Clinic of Psychiatry

    Belgrade, 11000
    Serbia

    Site Not Available

  • 584-Clinic for Psychiatry, Clinical Canter of Serbia

    Belgrade,
    Serbia

    Site Not Available

  • 587-Institute of Mental health

    Belgrade,
    Serbia

    Site Not Available

  • 472-Special Neuropsychiatric Hospital Kovin

    Kovin,
    Serbia

    Site Not Available

  • 423-Clinical Center Kragujevac, Clinic of Psychiatry

    Kragujevac,
    Serbia

    Site Not Available

  • 430-Psychiatric Clinic, Clinical Center Kragujevac

    Kragujevac, 34000
    Serbia

    Site Not Available

  • 427-Clinical Center Nis, Mental Health Protection Clinic

    Nis, 18000
    Serbia

    Site Not Available

  • 585-Special Hospital for Psychiatric Diseases "Gornja Toponica"

    Niš,
    Serbia

    Site Not Available

  • 593-Specialized Hospital for Neuropsychiatric Diseases "Sveti Vracevi"

    Novi Kneževac,
    Serbia

    Site Not Available

  • 574-Hospital Clinic de Barcelona

    Barcelona, 08036
    Spain

    Site Not Available

  • 576-Hospital Universitari Vall d'Hebron

    Barcelona, 8035
    Spain

    Site Not Available

  • 588-Institucion Hospitalaria Hestia Palau - Ensayos clinicos

    Barcelona,
    Spain

    Site Not Available

  • 475-Hospital Gregorio Marañon

    Madrid, 28007
    Spain

    Site Not Available

  • 575-Hospital Universitario 12 de Octubre

    Madrid, 28041
    Spain

    Site Not Available

  • 494-CSM La Corredoria

    Oviedo, 33011
    Spain

    Site Not Available

  • 431-Centro de Salud Parquesol, 2ª planta - Servicio de Psiquiatria

    Valladolid, 47016
    Spain

    Active - Recruiting

  • 431-Hospital Psiquiátrico Provincial Doctor Villacian

    Valladolid, 47016
    Spain

    Site Not Available

  • 529-Hospital Provincial de Zamora

    Zamora, 49021
    Spain

    Site Not Available

  • 508-CI Cherkasy Regional Psychiatric Hospital of ChRC

    Smila, Cherkas'ka Oblast 20708
    Ukraine

    Site Not Available

  • 564-Regional Clinical Psychiatric Hospital

    Kropyvnytskyi, Kirovograd Region 25491
    Ukraine

    Site Not Available

  • Kyiv City Psychoneurological Hospital #3 General Psychiatry Department No. 2

    Glevakha Town, Vasylkiv District Kyiv Region 8631
    Ukraine

    Site Not Available

  • 460-Kyiv City Psychoneurological Hospital #3 General Psychiatry Department No. 2

    Kyiv, Vasylkiv District Kyiv Region 08631
    Ukraine

    Site Not Available

  • Kyiv City Psychoneurological Hospital #3 General Psychiatry Department No. 2

    v.Glevakha, Vasylkiv District Kyiv Region 08631
    Ukraine

    Site Not Available

  • 434-State Institution "Institute of Neurology, Psychiatry and Narcology of NAMS of Ukraine", Department of Urgent Psychiatry and Narcology

    Kharkiv, 61068
    Ukraine

    Site 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
    Ukraine

    Site Not Available

  • 582-SI Institute of Neurology,Psychiatry&Narcology of NAMSU

    Kharkiv, 61068
    Ukraine

    Site Not Available

  • 435-Kyiv Regional Medical Incorporation "Psychiatry". Center of Novel Treatment and Rehabilitation of Psychotic disorders, build 5, Department #30

    Kyiv, 04080
    Ukraine

    Site 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,
    Ukraine

    Site 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
    Ukraine

    Site Not Available

  • 509-CI Odesa Regional Medical Centre of Mental Health

    Odesa, 65014
    Ukraine

    Site 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,
    Ukraine

    Site Not Available

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