Treatment Resistant Depression in America Latina

Completed

• Conditions: Depressive Disorder, Treatment-Resistant

• Registration Number: NCT03207282
• Lead Sponsor: Janssen-Cilag, S.A.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-06-30
• Study First Submitted QC: 2017-06-30
• Study First Posted: 2017-07-02
• Study Start: 2017-09-27
• Primary Completion: 2019-11-25
• Study Completion: 2019-11-25
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-25
• Last Update Posted: 2025-04-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1539

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Healthcare Resource Utilization in TRD Participants	Up to Month 12	Healthcare resources utilized in TRD participants will be estimated.
Percentage of Participants With Treatment Resistant Depression (TRD)	Baseline (Day 1)	Prevalence of TRD will be assessed as percentage of participants with TRD among Major Depressive Disorder (MDD) participants.

Secondary Outcome Measures

Name	Time	Method
Demographic Characteristics of TRD Participants	Baseline (Day 1)	Demographic characteristics (such as age and gender) of TRD participants will be assessed at baseline.
Treatment Patterns Over Time for TRD Participants	Baseline (Day 1) up to Month 12	Treatment patterns of TRD participants will be assessed over time.
Indirect Cost Associated With Work Productivity Loss	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.
Level of Disability as Measured by Sheehan Disability Scale (SDS)	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.
Indirect Cost Associated With Daily Functioning Loss	Baseline (Day 1) up to Month 12	Indirect cost associated with daily functioning loss will be determined.
Treatment Duration for MDD	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).
Treatment Pattern for TRD Participants by Line	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.
Severity of Symptoms as Measured by Montgomery-Asberg Depression Rating Scale (MADRS) Score	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.
Indirect Cost Associated With Caregiver Burden	Baseline (Day 1) and Month 12	Indirect cost associated with caregiver burden will be determined.
Number of Participants With Comorbid Conditions	Baseline (Day 1)	Comorbid conditions of TRD participants will be assessed at baseline.
Sequence of Drugs	Baseline (Day 1) up to Month 12	Sequence of drugs taken by TRD participants will be determined.
Healthcare Costs in TRD Participants	Up to Month 12	Total healthcare costs and healthcare costs related to depression will be determined in TRD participants.
Indirect Cost Associated With Quality of Life	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).
Suicidality Risk (Ideation and Attempts) as Measured by Columbia-Suicide Severity Rating Scale (C-SSRS) Score	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.

Trial Locations

Locations (33)

Fundacion para el Estudio y Tratamiento de las Enfermedades Mentales; 🇦🇷 Ciudad Autonoma de Buenos Aires, Argentina

C I A P Centro de investigacion y Asistencia en Psiquiatria; 🇦🇷 Rosario, Argentina

Universidade Federal De Minas Gerais - Hospital das Clínicas; 🇧🇷 Belo Horizonte, Brazil

Hospital das Clinicas de Porto Alegre; 🇧🇷 Porto Alegre, Brazil

Universidade Federal do Rio de Janeiro - Instituto de Psiquiatria; 🇧🇷 Rio de Janeiro, Brazil

Hospital Das Clinicas Da Faculdade De Medicina Da USP; 🇧🇷 Sao Paulo, Brazil

Hospital Aranda de la Parra S A de C V; 🇲🇽 Leon, Mexico

Instituto Nacional de Psiquiatria Ramon de la Fuente Muniz; 🇲🇽 Mexico City, Mexico

CESASIN; 🇦🇷 Ciudad de Mendoza, Argentina

Instituto DAMIC; 🇦🇷 Cordoba, Argentina

Clinica Privada de Salud Mental Santa Teresa de Ávila; 🇦🇷 La Plata, Argentina

Instituto De Neurociencias Dr. Quevedo Hospital Sao Sebastiao; 🇧🇷 Criciúma, Brazil

Trial Tech Tecnologia em Pesquisas com Medicamentos; 🇧🇷 Curitiba, Brazil

Universidade Federal Do Ceara; 🇧🇷 Fortaleza, Brazil

Instituto Bairral de Psiquiatria; 🇧🇷 Itapira, Brazil

Faculdade de Medicina da Universidade Federal de Pelotas; 🇧🇷 Pelotas, Brazil

Hospital Universitario Professor Edgar Santos; 🇧🇷 Salvador, Brazil

HOMO - ESE Hospital Mental de Antioquia; 🇨🇴 Bello, Colombia

Instituto Colombiano del Sistema Nervioso; 🇨🇴 Bogota, Colombia

Centro de Investigaciones del Sistema Nervioso Grupo Cisne Ltda.; 🇨🇴 Bogota, Colombia

Conciencia S.A.S; 🇨🇴 Medellín - Antioquia, Colombia

Grupo de Estudios Médicos y familiares Carraci SC; 🇲🇽 Ciudad de Mexico, Mexico

Estimulación Magnética Transcraneal de México S.C.; 🇲🇽 Ciudad de Mexico, Mexico

Hospital Psiquiátrico Granja la Salud Tlazolteotl; 🇲🇽 Ixtapaluca, Mexico

Hospital Psiquiatrico Fray Bernardino Alvarez; 🇲🇽 Mexico City, Mexico

Clínica de Neuropsiquiatría Tlatelolco ISSSTE; 🇲🇽 Mexico city, Mexico

Instituto Nacional de Neurología y Neurocirugía; 🇲🇽 Mexico, Mexico

Privarte Practice of Dr. Javier Zambrano; 🇲🇽 Mexico, Mexico

Instituto Jalisciense de Salud Mental; 🇲🇽 Mexico, Mexico

Centro para las Adicciones y Salud Mental S.A. de C.V.; 🇲🇽 Monterrey, Mexico

cit NEUROPSIQUE; 🇲🇽 Monterrey, Mexico

Hospital Central Dr Ignacio Morones Prieto; 🇲🇽 San Luis Potosi, Mexico

Clínica de Consulta Externa Alfredo del Mazo Vélez ISSEMyM; 🇲🇽 Toluca, Mexico