Evaluar la seguridad y tolerabilidad a largo plazo de pimavanserin tras 52 semanas de tratamiento adyuvante en sujetos con esquizofrenia.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Patient is able to understand and provide signed informed consent
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
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
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
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

Criterios de exclusión

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)
A urine drug screen (UDS) result at Baseline that indicates the presence of any tested prohibited substance of potential abuse
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
Subjects from Study 064 with a result indicating the presence of marijuana are not permitted in the study
Is taking a medication or drug or other substance that is prohibited according to this protocol
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
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).

Ubicaciones

610-Clinica Privada Banfield S.A.

Buenos Aires, Argentina

625-NOVAIN Neurociencias Group

Buenos Aires, Argentina

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

Ciudad Autonoma Buenos Aires, 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 Aire, 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

Estudio de extensión abierto de 52 semanas con pimavanserin para el tratamiento adyuvante de la esquizofrenia

Resumen

Elegibilidad

Criterios de inclusión

Criterios de exclusión

Intervenciones

Pimavanserin

Ubicaciones

610-Clinica Privada Banfield S.A.

625-NOVAIN Neurociencias Group

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

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