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

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 55 YearsSexo: ALL

Criterios de inclusión

Olanzapine
Lurasidone
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
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 of psychiatric disorder) and has been medically stable for at least 12 weeks prior to Screening, in the opinion of the Investigator

Criterios de exclusión

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
A confirmed urine drug screen (UDS) result at Baseline that indicates the presence of any tested prohibited substance of potential abuse, including marijuana
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
Has a history of myocardial infarction within 6 months prior to enrollment
Has a body mass index (BMI) \<19 or ≥35 at Screening

Ubicaciones

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

Buenos Aires, Argentina

610-Clinica Privada Banfield S.A.

Buenos Aires, Argentina

625-NOVAIN Neurociencias Group

Buenos Aires, Argentina

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

Ciudad Autonoma Buenos Aires, Argentina

602-FunDamoS

Ciudad Autonoma Buenos Aires, Argentina

622-Instituto Medico Damic Srl

Córdoba, Argentina

624-Centro Especializado en Neurociencias CEN

Córdoba, Argentina

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

Córdoba, Argentina

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

La Plata, Argentina

623-Clinica Privada de Salud Mental Santa Teresa de Avila

La Plata, Argentina

607-Resolution Psicopharmacology Research Institute

Mendoza, Argentina

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

Resumen

Elegibilidad

Criterios de inclusión

Criterios de exclusión

Intervenciones

Pimavanserin

Placebo

Ubicaciones

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

610-Clinica Privada Banfield S.A.

625-NOVAIN Neurociencias Group

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

602-FunDamoS

622-Instituto Medico Damic Srl

624-Centro Especializado en Neurociencias CEN

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

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

623-Clinica Privada de Salud Mental Santa Teresa de Avila

607-Resolution Psicopharmacology Research Institute

Patrocinadores