A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Pimavanserin as Adjunctive Treatment for the Negative Symptoms of Schizophrenia (ADVANCE-2)

  • STATUS
    Recruiting
  • End date
    Mar 20, 2023
  • participants needed
    426
  • sponsor
    ACADIA Pharmaceuticals Inc.
Updated on 20 September 2022
adjunctive treatment
antipsychotics
olanzapine
aripiprazole
lurasidone
risperidone
abilify
asenapine
paliperidone
cariprazine

Summary

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

Details
Condition Schizophrenia
Treatment Placebo, Pimavanserin
Clinical Study IdentifierNCT04531982
SponsorACADIA Pharmaceuticals Inc.
Last Modified on20 September 2022

Eligibility

Yes No Not Sure

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 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 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
Risperidone
Paliperidone extended release (ER) (≤9 mg)
Paliperidone palmitate
Risperidone long-acting injection
Invega Sustenna® (≤156 mg)
Invega Trinza® (≤546 mg)
Trevicta® (≤350 mg)
Xeplion® (≤100 mg)
Must be medically stable and has been medically stable for at least 12 weeks prior to
Screening, in the opinion of the Investigator

Exclusion Criteria

Has a current comorbid psychiatric disorder other than schizophrenia or a disorder that 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
Is taking a medication or drug or other substance that is prohibited according to this protocol, including medications that prolong the QT interval, strong cytochrome P450 (CYP) 3A4 enzyme (CYP3A4) inhibitors and inducers
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
Current evidence, or history within the previous 12 weeks prior to Screening, of a serious and/or unstable psychiatric, neurologic, cardiovascular, respiratory, gastrointestinal, renal, hepatic, hematologic, or other medical disorder, including cancer or malignancies that in the judgment of the Investigator would jeopardize the safe participation of the subject in the study
Has moderate to severe congestive heart failure
A urine drug screen (UDS) result at Baseline that indicates the presence of any tested prohibited substance of potential abuse, including marijuana
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)
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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