Extension Study of Pimavanserin for the Adjunctive Treatment of Schizophrenia

August 6, 2025 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

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
995

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Argentina
      • Buenos Aires, Argentina
        • 610-Clinica Privada Banfield S.A.
      • Ciudad Autonoma Buenos Aires, Argentina
        • 603-Fundación para el Estudio y Tratamiento de las Enfermedades Mentales - FETEM
      • Ciudad Autonoma de Buenos Aire, 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 Aires, Argentina
        • 625-NOVAIN Neurociencias Group
      • Ciudad de Mendoza, Argentina
        • 607-Resolution Psicopharmacology Research Institute
      • Cordoba, Argentina
        • 626-Sanatorio Prof. Leon S. Morra S.A.
      • Córdoba, Argentina
        • 622-Instituto Medico Damic Srl
      • Córdoba, Argentina
        • 624-Centro Especializado en Neurociencias CEN
      • La Plata, Argentina
        • 617-INSA Instituto de Neurociencias San Agustin S.A.
      • La Plata, Argentina
        • 623-Clinica Privada de Salud Mental Santa Teresa de Avila
  • Bulgaria
      • Burgas, Bulgaria, 8000
        • 454-Mental Health Centre 'Prof. Dr. Ivan Temkov', EOOD
      • Kardzhali, Bulgaria, 6600
        • 533-State Psychiatric Hospital - Kardzhali, EOOD
      • Kazanlak, Bulgaria
        • 532-MHAT "Dr. Hristo Stambolski", EOOD
      • Lovech, Bulgaria, 5500
        • 569-State Psychiatric Hospital - Lovech
      • Pazardzhik, Bulgaria, 4400
        • 406-State Psychiatric Hospital - Pazardzhik AD
      • Pleven, Bulgaria
        • 535-UMHAT 'Dr. Georgi Stranski', EAD
      • Plovdiv, Bulgaria, 4004
        • 586-Medical Center Mentalcare OOD
      • Plovdiv, Bulgaria, 4028
        • 563-MC-Hipokrat-N E00D
      • Plovdiv, Bulgaria
        • 592-Medical center Spectar - Plovdiv EOOD
      • Plovdiv, Bulgaria
        • 403-University Multiprofile hospital for activated treatment Sveti Georgi, Clinic of psychiatry
      • Sofia, Bulgaria, 1113
        • 570-Medical Centre "Sveti Naum"
      • Sofia, Bulgaria, 1408
        • 526-DCC "Sv. Vrach and Sv. Sv. Kuzma and Damyan", OOD
      • Sofia, Bulgaria, 1510
        • 568-Medical Center Hera EOOD
      • Sofia, Bulgaria, 1680
        • 528-Medical Center Intermedica, OOD
      • Sofia, Bulgaria, 1202
        • 497-MHC - Sofia, EOOD
      • Sofia, Bulgaria, 1431
        • 402-Military Medical Academy, Multiprofile Hospital for Actie Treatment - Sofia
      • Sofia, Bulgaria, 1431
        • 405-UMHAT "Alexandrovska" EAD
      • Targovishte, Bulgaria, 7700
        • 404-MHAT-Targovishte, AD
      • Tsarev Brod, Bulgaria
        • 590-State Psychiatric Hospital - Tzarev Brod
      • Varna, Bulgaria, 9020
        • 498-DCC "Mladost M" - Varna, OOD
      • Veliko Tarnovo, Bulgaria, 5000
        • 455-Mental Health Center - Veliko Tarnovo EOOD
      • Vratsa, Bulgaria, 3000
        • 401-Mental Health Center-Vratsa EOOD
  • Canada
      • Chatham, Canada, N7L 1C1
        • 356-Chatham-Kent Clinical Trials Research Ctr
    • Ontario
      • Chatham, Ontario, Canada, N7L1C1
        • Chatham-Kent Clinical Trials Research Ctr
    • Quebec
      • Montréal, Quebec, Canada, H3A 1A1
        • 351-McGill University Health Ctr Allan Memorial Int.
  • Croatia
      • Zagreb, Croatia
        • 594-Klinika za psihijatriju Sveti Ivan, n/p Igor Filipčić or Marija Zelenika
      • Zagreb, Croatia
        • 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
  • Czechia
      • Hradec Králové, Czechia, 50341
        • 512-NeuropsychiatrieHK s.r.o.
      • Klecany, Czechia
        • 583-Narodni ustav dusevniho zdravi
      • Plzen, Czechia, 31200
        • 519-A-SHINE s.r.o.
      • Praha 10, Czechia, 10000
        • 513-CLINTRIAL s.r.o.
      • Praha 10, Czechia, 10600
        • 499-MUDr. Tibor Miklos
      • Říčany, Czechia, 25101
        • 511-Psychiatrie Ricany s.r.o.
  • Hungary
      • Budapest, Hungary, 1135
        • 520-Nyiro Gyula Korhaz - Orszagos Pszichiatriai es Addiktologiai Intezet
      • Pécs, Hungary, 7633
        • 440-PsychoTech Kft.
    • Bács-Kiskun Megye
      • Kalocsa, Bács-Kiskun Megye, Hungary, 6300
        • 410-Dr. Máthé és Társa Bt.
    • Pest Megye
      • Budapest, Pest Megye, Hungary, 1036
        • 411-ÓBudai Egészségűgyi Centrum Kft
      • Budapest, Pest Megye, Hungary, 1083
        • 456-Semmelweis University Department of Psychiatry and Psychotherapy
  • Italy
      • Milano, Italy
        • 566-Ospedale San Raffaele (San Raffaele Turro)
      • Torino, Italy
        • 553-AO Città della Salute e della Scienza di Torino
  • Lithuania
      • Kaunas, Lithuania, LT-44279
        • 483-Romuvos klinika, UAB
      • Kaunas, Lithuania, LT-48259
        • 518-Kaunas City Outpatient Clinic, Public Institution
      • Silute, Lithuania
        • 484-Medical Center Puriena JSC
      • Vilnius, Lithuania, 09112
        • 517-Zirmunai Mental Health Center, Public Institution
  • Poland
      • Białystok, Poland, 15-756
        • 525-Podlaskie Centrum Psychogeriatrii
      • Bydgoszcz, Poland, 85-080
        • 502-Przychodnia Srodmiescie Sp. z o. o.
      • Gdańsk, Poland, 80-546
        • 579-Centrum Badan Klinicznych P.I. House Sp. z o.o.
      • Lublin, Poland, 20-582
        • 501-Specjalistyczna Praktyka Lekarska Marek Domański
      • Pruszków, Poland
        • 578-MSCZ im. Prof. J. Mazurkiewicza
  • Russian Federation
      • Arkhangel'sk, Russian Federation, 163530
        • 418-State Budget Healthcare Institution of Arkhangelsk Region "Arkhangelsk Clinical Psychiatric Hospital"
      • Leningrad, Russian Federation, 188820
        • 419-State municipal healthcare Institution "Leningrad region psychoneurological center"
      • Moscow, Russian Federation, 115522
        • 459-Federal State Budgetary Research Institution "Mental Health Science Center"
      • Moscow, 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
        • 581-SBIH of Moscow "Psych Clinical Hospital #1 N.A. Alekseev"
      • Saint Petersburg, Russian Federation, 190121
        • 415-Saint-Petersburg State Healthcare Institution "Saint Nicolas Wonderworker Psychiatric Hospital"
      • Saint Petersburg, Russian Federation, 192019
        • 451-V. M. Bekhterev National Research Medical Center For Psychiatry and Neurology
      • Saint Petersburg, Russian Federation, 192019
        • 453-"Saint-Petersburg Scientific Research Psychoneurological Institute n.a. V.M. Bekhterev"
      • Saint Petersburg, Russian Federation, 192019
        • 465-"Saint-Petersburg Scientific Research Psychoneurological Institute N.A. V.M. Bekhterev"
      • Saint Petersburg, Russian Federation, 192019
        • 495-FSBI "National Medical Scientifi Center of Psychiatry and Neurology n.a. V.M. Bekhterev" MoH
      • Saint Petersburg, Russian Federation, 195112
        • 443-Saint-Petersburg State Budget Healthcare Institution "Psychoneurological Center #5"
      • Saint Petersburg, Russian Federation, 197341
        • 444-SPHI "City Mental Hospital #3 n.a. I.I Skvortsov-Stepanov"
      • Saint Petersburg, Russian Federation, 197341
        • 452-Saint Petersburg State Public Institution of Healthcare "City Psychiatric Hospital #3 n.a.I.I. Skvortsov-Stepanov
      • Saint Petersburg, Russian Federation, 197341
        • 496-SPHI "City Mental Hospital #3 n.a. I.I Skvortsov-Stepanov
      • Saint Petersburg, Russian Federation, 443016
        • 458-State Budget Healthcare Institution "Samara Psychiatric Hospital"
      • Saint-Petersburg, Russian Federation, 190121
        • 571-St. Petersburg SHI "Psychoneurological Dispensary #10"
      • Saint-Petersburg, Russian Federation, 193167
        • 464-Saint Petersburg State Budget Healthcare Institution "City Psychiatric Hospital No. 6 (Inpatient Department with Treatment Center)"
      • Smolensk, Russian Federation, 214019
        • 416-FSBEI HE "Smolensk State Medical University" of the MoH of the RF
      • Stavropol', Russian Federation, 355000
        • 420-"Podderzhka" Research and Educational Center of Psychotherapy Limited Liability Company
      • Tomsk, Russian Federation
        • 572-Klinika StoLet" Ltd.
      • Voronezh, Russian Federation, 394024
        • 466-OOO "Lion-Med"
      • Yaroslavl, Russian Federation, 150003
        • 422-State Budget Healthcare Institution of Yaroslavl Region "Yaroslavl Region Clinical Psychiatric Hospital"
    • Lipetsk Region
      • Plekhanovo, Lipetsk Region, Russian Federation, 399313
        • 505-GUZ Lipetsk Regional psychoneurological Hospital #1
    • Stavropol Region
      • Tonnel'nyy, Stavropol Region, Russian Federation, 357034
        • 417-State Budget Healthcare Institution of Stavropol Region (Regional Specialized Psychiatric Hospital #2)
  • Serbia
      • Belgrad, Serbia, 11000
        • 424-Institute of Mental health
      • Belgrad, Serbia, 11000
        • 587-Institute of Mental Health
      • Belgrad, Serbia
        • 584-Clinic for Psychiatry, Clinical Canter of Serbia
      • Belgrade, Serbia, 11000
        • 425-Clinical Hospital Center "Dr. Dragisa Misovic-Dedinje", Clinic of Psychiatry
      • Belgrade, Serbia, 11 000
        • 428-Clinical center of Serbia
      • Belgrade, Serbia, 11000
        • 471-Clinic for Psychiatric Diseases "Dr Laza Lazarevic"
      • Belgrade, Serbia, 11000
        • 524-General Hospital Euromedik
      • Kovin, Serbia, 26220
        • 472-Special Hospital for Psychiatric Diseases "Kovin"
      • Kovin, Serbia, 26220
        • 493-Special Neuropsychiatric Hospital Kovin
      • Kragujevac, Serbia, 34 000
        • 423-Clinical Center Kragujevac
      • Kragujevac, Serbia, 34 000
        • 429-Clinical Center Kragujevac, Clinic of Psychiatry
      • Kragujevac, Serbia
        • 430-Psychiatric Clinic, Clinical Center Kragujevac
      • Nis, Serbia, 18 000
        • 427-Clinical Center Nis, Clinic of Mental Health
      • Niš, Serbia
        • 585-Special Hospital for Psychiatric Diseases "Gornja Toponica"
      • Novi Kneževac, Serbia
        • 593-Specialized Hospital for Neuropsychiatric Diseases "Sveti Vracevi"
  • Spain
      • Barcelona, Spain
        • 588-Institucion Hospitalaria Hestia Palau - Ensayos clinicos
      • Barcelona, Spain, 08830
        • 476-FIDMAG Germanes Hospitalaries
      • Barcelona, Spain
        • 574-Hospital Clinic de Barcelona
      • Madrid, Spain, 28007
        • 475-Hospital Gregorio Marañon
      • Madrid, Spain
        • 575-Hospital Universitario 12 de Octubre
      • Oviedo, Spain, 33011
        • 494-CSM La Corredoria
      • Valladolid, Spain, 47016
        • 431-Centro de Salud Parquesol, 2ª planta - Servicio de Psiquiatria
      • Zamora, Spain, 49021
        • 529-Hospital Provincial de Zamora
  • Ukraine
      • Dnipro, Ukraine, 49005
        • 462-Communal Establishment "I.I. Mechnykov Dnipropetrovsk Regional Clinical Hospital"
      • Hlevakha, Ukraine, 08631
        • 510-CI of Kyiv RC Regional Psychiatric-Narcological Medical Association, Depart #10 (male), Dept #2 (female)
      • Kharkiv, Ukraine, 61068
        • 434-State Institution "Institute of Neurology, Psychiatry and Narcology of NAMS of Ukraine", Department of Urgent Psychiatry and Narcology
      • Kharkiv, Ukraine, 61068
        • 582-SI Institute of Neurology,Psychiatry&Narcology of NAMSU
      • Kharkiv, Ukraine, 61068
        • 433-SI "Institute of Neurology, Psychiatry and Narcology of National Academy of Medical Sciences of Ukraine"
      • 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
      • Kherson, Ukraine, 73488
        • 461-Kherson Regional Psychiatric Hospital
      • Kyiv, Ukraine, 01133
        • 507-Main Military Clinical Hospital of MDU
      • Kyiv, Ukraine, 04080
        • 447-Ukrainian Scientific Research Institute of Social and Forensic Psychiatry and Narcology of Ministry of Healthcare of Ukraine
      • Kyiv, Ukraine, 04080
        • Kyiv Regional Medical Incorporation Psychiatry Center of Novel Treatment and Rehabilitation of Psychotic Disorders, Department #29, Department #30
      • Kyiv, Ukraine, 08631
        • 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
      • Nove, Ukraine
        • 564-Regional Clinical Psychiatric Hospital
      • Odesa, Ukraine, 65014
        • 509-CI Odesa Regional Medical Centre of Mental Health
      • Smila, Ukraine, 20708
        • 508-CI Cherkasy Regional Psychiatric Hospital of ChRC Female Dept #11, Male Dept #12
      • Vinnytsia, Ukraine, 21005
        • 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
      • Úzhgorod, 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
    • Oblast
      • Odessa, Oblast, Ukraine, 67513
        • 438-Communal Establishment "Odesa Regional Psychiatric Hospital #2"
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85012
        • 171-Alea Research Institute
    • Arkansas
      • Little Rock, Arkansas, United States, 72211
        • 156-Woodland International Research Group, LLC
      • Rogers, Arkansas, United States, 72758
        • 111-Woodland Research Northwest, LLC
    • California
      • Bellflower, California, United States, 90706
        • 167-CITrials - Bellflower
      • Culver City, California, United States, 90230
        • 105-ProScience Research Group
      • Lemon Grove, California, United States, 91945
        • 123-Synergy San Diego
      • San Diego, California, United States, 92103
        • 164-Artemis Institute for Clinical Research
      • Santa Ana, California, United States, 92705
        • 165-CITrials
      • Torrance, California, United States, 90502
        • 108-Collaborative Nueroscience Network, LLC
    • Florida
      • Hialeah, Florida, United States, 33016
        • 125-Galiz Research
      • Lauderhill, Florida, United States, 33319
        • 137-Innovative Clinical Research, Inc.
      • Miami, Florida, United States, 33122
        • 146-Premier Clinical Research Institute, Inc.
    • Georgia
      • Atlanta, Georgia, United States, 30328
        • 162-Synexus Clinical Research, Inc.
      • Atlanta, Georgia, United States, 30331
        • 168-Atlanta Center for Medical Research
      • Marietta, Georgia, United States, 30060
        • 102-Northwest Behavioral Research Center
    • Illinois
      • Chicago, Illinois, United States, 60611
        • 114-Northwestern University
      • Chicago, Illinois, United States, 60612
        • 101-American Medical Research
      • Hoffman Estates, Illinois, United States, 60169
        • 130-Alexian Brothers Center for Psychiatric Research
    • Louisiana
      • Lake Charles, Louisiana, United States, 70629
        • 118-Lake Charles Clinical Trials
    • Nevada
      • Las Vegas, Nevada, United States, 89102
        • 124-Altea Research Institute
    • New Jersey
      • Berlin, New Jersey, United States, 08009
        • 141-Hassman Research Institute
    • New Mexico
      • Albuquerque, New Mexico, United States, 87109
        • 153-Albuquerque Neuroscience Inc.
    • New York
      • Cedarhurst, New York, United States, 11516
        • 104-Neurobehavioral Research, Inc.
      • Jamaica, New York, United States, 11432
        • 140-Synexus Clinical Research, Inc - 140
      • Rochester, New York, United States, 14618
        • 128-Finger Lakes Clinical Research
    • North Carolina
      • Charlotte, North Carolina, United States, 28211
        • 106-New Hope Clinical Research
      • Durham, North Carolina, United States, 27704
        • 145-Carolina Behavioral Care
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73116
        • 110-Cutting Edge Research Group
    • Pennsylvania
      • Downingtown, Pennsylvania, United States, 19335
        • 170-Suburban Research Associates
    • Texas
      • Irving, Texas, United States, 75062
        • 127-University Hills Clinical Research
      • Richardson, Texas, United States, 75080
        • 103-Pillar Clinical Research, LLC
    • Utah
      • Salt Lake City, Utah, United States, 84105
        • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Patient is able to understand and provide signed informed consent
  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:

  1. 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)

  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).

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Drug - Pimavanserin
Pimavanserin 34 mg, 20 mg, or 10 mg, + background antipsychotic, taken once daily by mouth
Drug: 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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Treatment Emergent Adverse Events
Time Frame: Treatment period (52 weeks) and follow-up period (30 days): planned total of 56 weeks. Since the study was prematurely terminated, the reporting period was shortened; AEs were assessed to the end of treatment, at a mean duration of 319 days (or 46 weeks).
Number of patients with treatment emergent adverse events
Treatment period (52 weeks) and follow-up period (30 days): planned total of 56 weeks. Since the study was prematurely terminated, the reporting period was shortened; AEs were assessed to the end of treatment, at a mean duration of 319 days (or 46 weeks).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
ACADIA Pharmaceuticals Inc.

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 30, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 30, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 13, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 17, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 20, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 24, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 6, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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Dietary Supplements

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