Treatment Resistant Depression in America Latina (TRAL)

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
• Conditions: Depressive Disorder, Treatment-Resistant

• Study Type: Observational
• Enrollment (Actual): 1539

Contacts and Locations

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 Avila
  • Rosario, Argentina, 2000
    • C.I.A.P. (Centro de investigación y Asistencia en Psiquiatría)
• Brazil
  • Bahia, Brazil, 40110-060
    • Hospital Universitario Professor Edgar Santos
  • Belo Horizonte, Brazil, 301301
    • Hospital das Clínicas 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 clinicas de Porto Alegre
  • Rio de Janeiro, Brazil, 22290-140
    • UFRJ - Instituto de Psiquiatria
  • Sao Paulo, Brazil, 05403-903
    • Instituto de Psiquiatria - Hcfmusp
• Colombia
  • 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
• 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 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

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

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

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)	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Demographic Characteristics of TRD Participants	Demographic characteristics (such as age and gender) of TRD participants will be assessed at baseline.	Baseline (Day 1)
Number of Participants With Comorbid Conditions	Comorbid conditions of TRD participants will be assessed at baseline.	Baseline (Day 1)
Treatment Patterns Over Time for TRD Participants	Treatment patterns of TRD participants will be assessed over time.	Baseline (Day 1) up to Month 12
Treatment Duration for MDD	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	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	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	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)	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	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	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	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	Indirect cost associated with daily functioning loss will be determined.	Baseline (Day 1) up to Month 12
Indirect Cost Associated With Caregiver Burden	Indirect cost associated with caregiver burden will be determined.	Baseline (Day 1) and Month 12
Indirect Cost Associated With Quality of Life	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

• Sponsor: Janssen-Cilag, S.A.
• Investigators: Study Director: Jannsen Cilag S.A. Clinical Trial, Jannsen Cilag S.A.

Publications and helpful links

General Publications

• 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.

Study record dates

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

• Additional Relevant MeSH Terms: Mental Disorders; Mood Disorders; Depressive Disorder; Depressive Disorder, Treatment-Resistant
• 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