Treatment Resistant Depression in America Latina (TRAL)

April 25, 2025 updated by: Janssen-Cilag, S.A.
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1539

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Ciudad Autonoma de Buenos Aires, Argentina, C1425AHQ
        • Fundacion para el Estudio y Tratamiento de las Enfermedades Mentales
      • Ciudad de Mendoza, Argentina, 5500
        • CESASIN
      • Cordoba, Argentina, X5003DCE
        • Instituto DAMIC
      • La Plata, Argentina, B1904ADM
        • Clinica Privada de Salud Mental Santa Teresa de Ávila
      • Rosario, Argentina, 2000
        • C I A P Centro de investigacion y Asistencia en Psiquiatria
  • Brazil
      • Belo Horizonte, Brazil, 30130-100
        • Universidade Federal De Minas Gerais - Hospital das Clínicas
      • Criciúma, Brazil, 88801-250
        • Instituto De Neurociencias Dr. Quevedo Hospital Sao Sebastiao
      • Curitiba, Brazil, 80240-280
        • Trial Tech Tecnologia em Pesquisas com Medicamentos
      • Fortaleza, Brazil, 60020-181
        • Universidade Federal do Ceara
      • Itapira, Brazil, 13970-905
        • Instituto Bairral de Psiquiatria
      • Pelotas, Brazil, 96030-002
        • Faculdade de Medicina da Universidade Federal de Pelotas
      • Porto Alegre, Brazil, 90035-903
        • Hospital das Clinicas de Porto Alegre
      • Rio de Janeiro, Brazil, 22290-140
        • Universidade Federal do Rio de Janeiro - Instituto de Psiquiatria
      • Salvador, Brazil, 40110-060
        • Hospital Universitario Professor Edgar Santos
      • Sao Paulo, Brazil, 05403-903
        • Hospital das Clinicas da Faculdade de Medicina da USP
  • Colombia
      • Bello, Colombia, 051053
        • HOMO - ESE Hospital Mental de Antioquia
      • Bogota, Colombia, 110121
        • Instituto Colombiano del Sistema Nervioso
      • Bogota, Colombia, 111166
        • Centro de Investigaciones del Sistema Nervioso Grupo Cisne Ltda.
      • Medellín - Antioquia, Colombia, 050021
        • Conciencia S.A.S
  • Mexico
      • Ciudad de Mexico, Mexico, 03740
        • Grupo de Estudios Médicos y familiares Carraci SC
      • Ciudad de Mexico, Mexico, 11006
        • Estimulación Magnética Transcraneal de México S.C.
      • Ixtapaluca, Mexico, 56530
        • Hospital Psiquiátrico Granja la Salud Tlazolteotl
      • Leon, Mexico, 37000
        • Hospital Aranda de la Parra S A de C V
      • Mexico, Mexico, 14269
        • Instituto Nacional de Neurologia y Neurocirugia
      • Mexico, Mexico, 15900
        • Privarte Practice of Dr. Javier Zambrano
      • Mexico, Mexico, 45170
        • Instituto Jalisciense de Salud Mental
      • Mexico City, Mexico, 14000
        • Hospital Psiquiátrico Fray Bernardino Álvarez
      • Mexico City, Mexico, 14370
        • Instituto Nacional de Psiquiatria Ramon de la Fuente Muniz
      • Mexico city, Mexico, 6900
        • Clínica de Neuropsiquiatría Tlatelolco ISSSTE
      • Monterrey, Mexico, 64060
        • Centro para las Adicciones y Salud Mental S.A. de C.V.
      • Monterrey, Mexico, 64610
        • cit NEUROPSIQUE
      • San Luis Potosi, Mexico, 78240
        • Hospital Central Dr Ignacio Morones Prieto
      • Toluca, Mexico, 50080
        • Clínica de Consulta Externa Alfredo del Mazo Vélez ISSEMyM

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Treatment Resistant Depression (TRD)
Time Frame: Baseline (Day 1)
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
Time Frame: Up to Month 12
Healthcare resources utilized in TRD participants will be estimated.
Up to Month 12

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Demographic Characteristics of TRD Participants
Time Frame: Baseline (Day 1)
Demographic characteristics (such as age and gender) of TRD participants will be assessed at baseline.
Baseline (Day 1)
Number of Participants With Comorbid Conditions
Time Frame: Baseline (Day 1)
Comorbid conditions of TRD participants will be assessed at baseline.
Baseline (Day 1)
Treatment Patterns Over Time for TRD Participants
Time Frame: Baseline (Day 1) up to Month 12
Treatment patterns of TRD participants will be assessed over time.
Baseline (Day 1) up to Month 12
Treatment Duration for MDD
Time Frame: Baseline (Day 1) up to Month 12
Treatment duration is defined as the time interval between baseline and time to next therapy (since the date of the first and second regimen to the start of third regimen).
Baseline (Day 1) up to Month 12
Treatment Pattern for TRD Participants by Line
Time Frame: Baseline (Day 1) up to Month 12
Treatment patterns for TRD participants will be determined by distribution of every line of the treatment regimen including pharmaceutical and non-pharmaceutical treatments.
Baseline (Day 1) up to Month 12
Sequence of Drugs
Time Frame: Baseline (Day 1) up to Month 12
Sequence of drugs taken by TRD participants will be determined.
Baseline (Day 1) up to Month 12
Severity of Symptoms as Measured by Montgomery-Asberg Depression Rating Scale (MADRS) Score
Time Frame: Baseline (Day 1), Month 3, 6, 9 and 12
The MADRS is a 10 item scale for the evaluation of depressive symptoms (Montgomery et al 1979). The MADRS evaluates apparent sadness, reported sadness, inner tension, sleep, appetite, concentration, lassitude, interest level, pessimistic thoughts, and suicidal thoughts. Each MADRS item is rated on a 0 to 6 scale with a total score ranging from 0 60. Higher MADRS scores indicate higher levels of depressive symptoms (more severe condition) and lower scores indicate a decreased severity of depression.
Baseline (Day 1), Month 3, 6, 9 and 12
Level of Disability as Measured by Sheehan Disability Scale (SDS)
Time Frame: Baseline (Day 1), Month 6, and 12
SDS is a composite of 3 self-rated items designed to measure the extent to which 3 major sectors in the participant's life are impaired by panic, anxiety, phobic, or depressive symptoms. The participant rates the extent to which his or her (1) work, (2) social life or leisure activities, and (3) home life or family responsibilities are impaired by his or her symptoms on a 10-point visual analog scale. To get a total score add up the 3 individual scores and the total score ranges from "0 = unimpaired" to "30 = highly impaired". Higher scores indicate worsening.
Baseline (Day 1), Month 6, and 12
Suicidality Risk (Ideation and Attempts) as Measured by Columbia-Suicide Severity Rating Scale (C-SSRS) Score
Time Frame: Baseline (Day 1), Month 3, 6, 9, and 12
Suicidal ideation or behavior will be measured using C SSRS score. C-SSRS is a clinician rated assessment of suicidal behavior and/ or intent. Scale consists of 28 items in 4 sections: suicide behavior, actual attempts, suicidal ideation, and intensity of ideation. Suicidal ideation consists of 5 yes/no items: wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with any methods (not plan) without intention to act, active suicidal ideation with some intent to act without specific plan, active suicidal ideation with specific plan and intent. Worsening of suicidal ideation was an increase in severity of suicidal ideation from baseline.
Baseline (Day 1), Month 3, 6, 9, and 12
Healthcare Costs in TRD Participants
Time Frame: Up to Month 12
Total healthcare costs and healthcare costs related to depression will be determined in TRD participants.
Up to Month 12
Indirect Cost Associated With Work Productivity Loss
Time Frame: Baseline (Day 1) up to Month 12
Work productivity loss was measured by Work Productivity and Activity Impairment Questionnaire (WPAI). The WPAI is a validated, self-administered questionnaire that assesses work and activity impairment during the past 7 days. The WPAI produces 4 types of scores: absenteeism (work time missed), presenteeism (impairment at work/reduced on the job effectiveness), work productivity loss (overall work impairment/absenteeism plus presenteeism), and activity impairment. The WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity, that is, worse outcomes.
Baseline (Day 1) up to Month 12
Indirect Cost Associated With Daily Functioning Loss
Time Frame: Baseline (Day 1) up to Month 12
Indirect cost associated with daily functioning loss will be determined.
Baseline (Day 1) up to Month 12
Indirect Cost Associated With Caregiver Burden
Time Frame: Baseline (Day 1) and Month 12
Indirect cost associated with caregiver burden will be determined.
Baseline (Day 1) and Month 12
Indirect Cost Associated With Quality of Life
Time Frame: Baseline (Day 1) and Month 12
Quality of life will be measured by EuroQol-5 Dimension (EQ-5D). The EQ-5D descriptive system comprises the following 5 dimensions: Mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each of the 5 dimensions is divided into 3 levels of perceived problems (Level 1 indicating no problem, Level 2 indicating slight problems, Level 3 indicating extreme problems). The participant selects an answer for each of the 5 dimensions considering the response that best matches his or her health "today." The descriptive system can be represented as a health state. The EQ-VAS self-rating records the respondent's own assessment of his or her overall health status, on a scale of 0 (worst imaginable health state) to 100 (best imaginable health state).
Baseline (Day 1) and Month 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Janssen-Cilag, S.A.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Jannsen Cilag S.A. Clinical Trial, Jannsen Cilag S.A.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 27, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 25, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 25, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 30, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 30, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 2, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 27, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 25, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CR108329
  • 54135419RSD4001 (Other Identifier: Jannsen Cilag S.A.)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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