Treatment Resistant Depression in America Latina (TRAL)

Janssen (J&J Innovative Medicine)

Status: Completed

Conditions: Depressive Disorder, Treatment-Resistant

Study type: Observational

Funder types: Industry

Identifiers

NCT03207282

54135419RSD4001 (Other Identifier)

CR108329

Details and patient eligibility

About

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.

Enrollment: 1,539 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

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:

  1. Adequate follow-up and treatment with at least 2 antidepressants

  2. Without complete response to treatment (based on Montgomery-Asberg Depression Rating Scale [MADRS])

     Exclusion Criteria:

• 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

Trial design

1,539 participants in 1 patient group

Participants with Diagnosis of Depression

Description:

Study population consists of participants with a clinical diagnosis of depression, being treated in a psychiatry reference site (example, clinic, ambulatory, hospital, day-hospital) in 4 Latin American countries. Participants with Major Depressive Disorder (MDD) enrolled in Phase 1, will be assessed to estimate the prevalence of Treatment Resistant Depression (TRD) and participants with this diagnosis will be included in Phase 2. Participants with TRD will be followed-up for 1 year.