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Extension Study of Pimavanserin for the Adjunctive Treatment of Schizophrenia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03121586
Recruitment Status : Recruiting
First Posted : April 20, 2017
Last Update Posted : November 13, 2019
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: Pimavanserin Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A 52-Week, Open-Label, Extension Study of Pimavanserin for the Adjunctive Treatment of Schizophrenia
Actual Study Start Date : December 2016
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : May 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Evaluate the long-term safety and tolerability of pimavanserin (e.g., Summary of Treatment-Emergent Adverse Events [Safety and Tolerability]) [ Time Frame: 52 weeks ]
    Evaluate the long-term safety and tolerability of pimavanserin after 52 weeks of adjunctive treatment in subjects with schizophrenia

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 -039 or the Week 26 visit in Study ACP-103-038 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 female, must 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 be one of the antipsychotics listed below:

    • Aripiprazole
    • Aripiprazole long-acting injectables:

      • Abilify Maintena®
      • Aristada®
    • Asenapine
    • Risperidone
    • Risperidone long-acting injection
    • Olanzapine
    • 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 -039)
  2. A urine drug screen (UDS) result at Baseline that indicates the presence of any tested prohibited substance of potential abuse, except marijuana

    a. Patients with a result indicating the presence of marijuana are permitted if they agree to abstain from marijuana use during the study and the medical monitor approves the subject's participation

  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
  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 program.

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03121586

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Contact: Dragana Bugarski-Kirola, MD 609-250-6903
Contact: Ken Smith 609-250-6908

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Sponsors and Collaborators
ACADIA Pharmaceuticals Inc.
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Responsible Party: ACADIA Pharmaceuticals Inc. Identifier: NCT03121586    
Other Study ID Numbers: ACP-103-035
2016-003435-38 ( EudraCT Number )
First Posted: April 20, 2017    Key Record Dates
Last Update Posted: November 13, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Antiparkinson Agents
Anti-Dyskinesia Agents
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin 5-HT2 Receptor Antagonists
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action