Treatment Resistant Depression in America Latina

CompletadoClinicalTrials.gov

ID: NCT03207282Tipo: OBSERVATIONALInicio: 27 de sept de 2017Fin estimado: 25 de nov de 2019

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Resumen

The purpose of this study is to estimate the prevalence of Treatment Resistant Depression (TRD) among Major Depressive Disorder (MDD) participants being treated in a psychiatry reference site (example, clinic, ambulatory, hospital, day-hospital) in 4 Latin American countries: Argentina, Brazil, Colombia and Mexico; and to evaluate all and depression-related healthcare resource utilization in TRD participants.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Phase 1:
Major depressive disorder (MDD) diagnosis according to the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV), that was confirmed by MINI International Neuropsychiatric Interview, 5.0 version (MINI)
Treated or untreated participants with a new or continued episode of depression at the time of the enrolment
Participants must be capable of completing the corresponding assessments in the study
Participants must be capable of signing the informed consent form
Phase 2:
Diagnosis of Treatment Resistant Depression (TRD), to be described by the investigator, based on the criteria:
Adequate follow-up and treatment with at least 2 antidepressants
Without complete response to treatment (based on Montgomery-Asberg Depression Rating Scale \[MADRS\])

Criterios de exclusión

Participants diagnosed of psychosis, schizophrenia, bipolar disorder, schizoaffective disorder, or dementia
Participants with substance dependence considered serious by the investigator
Participant currently participating in another clinical study

Ubicaciones

Fundacion para el Estudio y Tratamiento de las Enfermedades Mentales

Buenos Aires, Argentina

Instituto DAMIC

Córdoba, Argentina

Clinica Privada de Salud Mental Santa Teresa de Ávila

La Plata, Argentina

CESASIN

Mendoza, Argentina

C I A P Centro de investigacion y Asistencia en Psiquiatria

Rosario, Argentina

Patrocinadores

PrincipalJanssen-Cilag, S.A.

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