Treatment Resistant Depression in America Latina

Depressive Disorder, Treatment-Resistant Clinical Trial

— TRAL  

Official title:

Treatment Resistant Depression in America Latina

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03207282
• Other study ID #: CR108329
• Secondary ID: 54135419RSD4001
• Status: Completed
• Start date: September 27, 2017
• Est. completion date: November 25, 2019

Study information

• Verified date: December 2021
• Source: Janssen-Cilag, S.A.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1539
• Est. completion date: November 25, 2019
• Est. primary completion date: November 25, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Depressive Disorder
• Depressive Disorder, Treatment-Resistant

Locations

Country	Name	City	State
Argentina	Fundación para el Estudio y Tratamiento de las Enfermedades Mentales	Ciudad Autonoma de Buenos Aires
Argentina	CESASIN	Ciudad de Mendoza
Argentina	Instituto DAMIC	Cordoba
Argentina	Clinica Privada de Salud Mental Santa Teresa de Ávila	La Plata
Argentina	C.I.A.P. (Centro de investigación y Asistencia en Psiquiatría)	Rosario
Brazil	Hospital Universitario Professor Edgar Santos	Bahia
Brazil	Hospital Das Clinicas Da Universidade Federal De Minas Gerais	Belo Horizonte
Brazil	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 de Clínicas de Porto Alegre	Porto Alegre
Brazil	UFRJ - Instituto de Psiquiatria	Rio de Janeiro
Brazil	Instituto de Psiquiatria - Hcfmusp	Sao Paulo
Colombia	HOMO - ESE Hospital Mental de Antioquia	Bello
Colombia	Instituto Colombiano del Sistema Nervioso	Bogota
Colombia	Centro de Investigaciones del Sistema Nervioso Grupo Cisne Ltda.	Bogotá
Colombia	Conciencia S.A.S	Medellín - Antioquia
Mexico	Estimulación Magnética Transcraneal de México S.C.	Ciudad de Mexico
Mexico	Grupo de Estudios Médicos y familiares Carraci SC	Ciudad de Mexico
Mexico	Hospital Psiquiátrico Granja la Salud Tlazolteotl	Ixtapaluca
Mexico	Hospital Aranda de la Parra S.A. de C.V.	Leon
Mexico	Instituto Jalisciense de Salud Mental	Mexico
Mexico	Instituto Nacional de Neurología y Neurocirugía	Mexico
Mexico	Privarte Practice of Dr. Javier Zambrano	Mexico
Mexico	Clínica de Neuropsiquiatría Tlatelolco ISSSTE	Mexico city
Mexico	Hospital Psiquiatrico Fray Bernardino Alvarez	Mexico City
Mexico	Instituto Nacional de Psiquiatría 'Ramón de la Fuente Muñiz'	Mexico City
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

Sponsors (1)

Lead Sponsor	Collaborator
Janssen-Cilag, S.A.

Countries where clinical trial is conducted

Argentina,  Brazil,  Colombia,  Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	Healthcare Resource Utilization in TRD Participants	Healthcare resources utilized in TRD participants will be estimated.	Up to Month 12
Secondary	Demographic Characteristics of TRD Participants	Demographic characteristics (such as age and gender) of TRD participants will be assessed at baseline.	Baseline (Day 1)
Secondary	Number of Participants With Comorbid Conditions	Comorbid conditions of TRD participants will be assessed at baseline.	Baseline (Day 1)
Secondary	Treatment Patterns Over Time for TRD Participants	Treatment patterns of TRD participants will be assessed over time.	Baseline (Day 1) up to Month 12
Secondary	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
Secondary	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
Secondary	Sequence of Drugs	Sequence of drugs taken by TRD participants will be determined.	Baseline (Day 1) up to Month 12
Secondary	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
Secondary	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
Secondary	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
Secondary	Healthcare Costs in TRD Participants	Total healthcare costs and healthcare costs related to depression will be determined in TRD participants.	Up to Month 12
Secondary	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
Secondary	Indirect Cost Associated With Daily Functioning Loss	Indirect cost associated with daily functioning loss will be determined.	Baseline (Day 1) up to Month 12
Secondary	Indirect Cost Associated With Caregiver Burden	Indirect cost associated with caregiver burden will be determined.	Baseline (Day 1) and Month 12
Secondary	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