Treatment Resistant Depression in America Latina

NCT03207282 | Completed

• 2 other identifiers: CR10832954135419RSD4001
• Study Type: observational
• Target: 1,539
• Locations: 4 countries
• Sites: 33

Brief Summary

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.

Conditions

Depressive Disorder, Treatment-Resistant

Outcome Measures

Primary Outcomes (2)

• Percentage of Participants With Treatment Resistant Depression (TRD)

  Prevalence of TRD will be assessed as percentage of participants with TRD among Major Depressive Disorder (MDD) participants.

  Baseline (Day 1)

• Healthcare Resource Utilization in TRD Participants

  Healthcare resources utilized in TRD participants will be estimated.

  Up to Month 12

Secondary Outcomes (14)

• Demographic Characteristics of TRD Participants

  Baseline (Day 1)

• Number of Participants With Comorbid Conditions

  Baseline (Day 1)

• Treatment Patterns Over Time for TRD Participants

  Baseline (Day 1) up to Month 12

• Treatment Duration for MDD

  Baseline (Day 1) up to Month 12

• Treatment Pattern for TRD Participants by Line

  Baseline (Day 1) up to Month 12

Study Arms (1)

Participants with Diagnosis of Depression

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Study population consists of participants with Major Depressive Disorder (MDD) being treated in a psychiatry reference site (clinic, ambulatory, hospital, day-hospital) in 4 Latin American countries and will be assessed to estimate the prevalence of Treatment Resistant Depression (TRD) among MDD participants.

You may qualify if:

• 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 \[MADRS\])

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen-Cilag, S.A.: lead

Study Sites (33)

Fundacion para el Estudio y Tratamiento de las Enfermedades Mentales

Buenos Aires, C1425AHQ, Argentina

Location

Instituto DAMIC

Córdoba, X5003DCE, Argentina

Location

Clinica Privada de Salud Mental Santa Teresa de Ávila

La Plata, B1904ADM, Argentina

Location

CESASIN

Mendoza, 5500, Argentina

Location

C I A P Centro de investigacion y Asistencia en Psiquiatria

Rosario, 2000, Argentina

Location

Universidade Federal De Minas Gerais - Hospital das Clínicas

Belo Horizonte, 30130-100, Brazil

Location

Instituto De Neurociencias Dr. Quevedo Hospital Sao Sebastiao

Criciúma, 88801-250, Brazil

Location

Trial Tech Tecnologia em Pesquisas com Medicamentos

Curitiba, 80240-280, Brazil

Location

Universidade Federal Do Ceara

Fortaleza, 60020-181, Brazil

Location

Instituto Bairral de Psiquiatria

Itapira, 13970-905, Brazil

Location

Faculdade de Medicina da Universidade Federal de Pelotas

Pelotas, 96030-002, Brazil

Location

Hospital das Clinicas de Porto Alegre

Porto Alegre, 90035-903, Brazil

Location

Universidade Federal do Rio de Janeiro - Instituto de Psiquiatria

Rio de Janeiro, 22290-140, Brazil

Location

Hospital Universitario Professor Edgar Santos

Salvador, 40110-060, Brazil

Location

Hospital Das Clinicas Da Faculdade De Medicina Da USP

São Paulo, 05403-903, Brazil

Location

HOMO - ESE Hospital Mental de Antioquia

Bello, 051053, Colombia

Location

Instituto Colombiano del Sistema Nervioso

Bogotá, 110121, Colombia

Location

Centro de Investigaciones del Sistema Nervioso Grupo Cisne Ltda.

Bogotá, 111166, Colombia

Location

Conciencia S.A.S

Medellín - Antioquia, 050021, Colombia

Location

Hospital Psiquiátrico Granja la Salud Tlazolteotl

Ixtapaluca, 56530, Mexico

Location

Hospital Aranda de la Parra S A de C V

León, 37000, Mexico

Location

Grupo de Estudios Médicos y familiares Carraci SC

Mexico City, 03740, Mexico

Location

Estimulación Magnética Transcraneal de México S.C.

Mexico City, 11006, Mexico

Location

Hospital Psiquiatrico Fray Bernardino Alvarez

Mexico City, 14000, Mexico

Location

Instituto Nacional de Psiquiatria Ramon de la Fuente Muniz

Mexico City, 14370, Mexico

Location

Clínica de Neuropsiquiatría Tlatelolco ISSSTE

Mexico City, 6900, Mexico

Location

Instituto Nacional de Neurología y Neurocirugía

México, 14269, Mexico

Location

Privarte Practice of Dr. Javier Zambrano

México, 15900, Mexico

Location

Instituto Jalisciense de Salud Mental

México, 45170, Mexico

Location

Centro para las Adicciones y Salud Mental S.A. de C.V.

Monterrey, 64060, Mexico

Location

cit NEUROPSIQUE

Monterrey, 64610, Mexico

Location

Hospital Central Dr Ignacio Morones Prieto

San Luis Potosí City, 78240, Mexico

Location

Clínica de Consulta Externa Alfredo del Mazo Vélez ISSEMyM

Toluca, 50080, Mexico

Location

Related Publications (1)

• Soares B, Kanevsky G, Teng CT, Perez-Esparza R, Bonetto GG, Lacerda ALT, Uribe ES, Cordoba R, Lupo C, Samora AM, Cabrera P. Prevalence and Impact of Treatment-Resistant Depression in Latin America: a Prospective, Observational Study. Psychiatr Q. 2021 Dec;92(4):1797-1815. doi: 10.1007/s11126-021-09930-x. Epub 2021 Aug 31.

  PMID: 34463905 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Treatment-Resistant

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Jannsen Cilag S.A. Clinical Trial

  Jannsen Cilag S.A.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2017
• First Posted: July 2, 2017
• Study Start: September 27, 2017
• Primary Completion: November 25, 2019
• Study Completion: November 25, 2019
• Last Updated: April 27, 2025

Record last verified: 2025-04

Locations

ME (14); BR (10); CO (4); AR (5)