Treatment Resistant Depression in America Latina (TRAL)

December 8, 2021 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

Completed

Study Type

Observational

Enrollment (Actual)

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

      • 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 Avila
      • Rosario, Argentina, 2000
        • C.I.A.P. (Centro de investigación y Asistencia en Psiquiatría)
      • Bahia, Brazil, 40110-060
        • Hospital Universitario Professor Edgar Santos
      • Belo Horizonte, Brazil, 301301
        • Hospital das Clinicas da Universidade Federal de Minas Gerais
      • 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, 60430-370
        • 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 de Clínicas de Porto Alegre
      • Rio de Janeiro, Brazil, 22290-140
        • UFRJ - Instituto de Psiquiatria
      • Sao Paulo, Brazil, 05403-903
        • Instituto de Psiquiatria - Hcfmusp
      • Bello, Colombia, 051053
        • HOMO - ESE Hospital Mental de Antioquia
      • Bogota, Colombia, 110121
        • Instituto Colombiano del Sistema Nervioso
      • Bogotá, Colombia, 111166
        • Centro de Investigaciones del Sistema Nervioso Grupo Cisne Ltda.
      • Medellín - Antioquia, Colombia, 050021
        • Conciencia S.A.S
      • 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 Psiquiatrico Fray Bernardino Alvarez
      • Mexico City, Mexico, 14370
        • Instituto Nacional de Psiquiatría 'Ramón de la Fuente Muñiz'
      • 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

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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
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

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

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.

Investigators

  • 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.

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)

September 27, 2017

Primary Completion (Actual)

November 25, 2019

Study Completion (Actual)

November 25, 2019

Study Registration Dates

First Submitted

June 30, 2017

First Submitted That Met QC Criteria

June 30, 2017

First Posted (Actual)

July 2, 2017

Study Record Updates

Last Update Posted (Actual)

December 10, 2021

Last Update Submitted That Met QC Criteria

December 8, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Other Study ID 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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