Clinical trial NCT03207282: Treatment Resistant Depression in America Latina
Official title: Treatment Resistant Depression in America Latina
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Depressive Disorder, Treatment-Resistant
Lead sponsor: Janssen-Cilag, S.A.
Sponsor class: INDUSTRY
First posted: 2017-07-02
Enrollment: 1539
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Participants With Treatment Resistant Depression (TRD)
timeFrame: Baseline (Day 1)
measure: Healthcare Resource Utilization in TRD Participants
timeFrame: Up to Month 12
Secondary outcomes:
measure: Demographic Characteristics of TRD Participants
timeFrame: Baseline (Day 1)
measure: Number of Participants With Comorbid Conditions
timeFrame: Baseline (Day 1)
measure: Treatment Patterns Over Time for TRD Participants
timeFrame: Baseline (Day 1) up to Month 12
measure: Treatment Duration for MDD
timeFrame: Baseline (Day 1) up to Month 12
measure: Treatment Pattern for TRD Participants by Line
timeFrame: Baseline (Day 1) up to Month 12
measure: Sequence of Drugs
timeFrame: Baseline (Day 1) up to Month 12
measure: Severity of Symptoms as Measured by Montgomery-Asberg Depression Rating Scale (MADRS) Score
timeFrame: Baseline (Day 1), Month 3, 6, 9 and 12
measure: Level of Disability as Measured by Sheehan Disability Scale (SDS)
timeFrame: Baseline (Day 1), Month 6, and 12
measure: Suicidality Risk (Ideation and Attempts) as Measured by Columbia-Suicide Severity Rating Scale (C-SSRS) Score
timeFrame: Baseline (Day 1), Month 3, 6, 9, and 12
measure: Healthcare Costs in TRD Participants
timeFrame: Up to Month 12
measure: Indirect Cost Associated With Work Productivity Loss
timeFrame: Baseline (Day 1) up to Month 12
measure: Indirect Cost Associated With Daily Functioning Loss
timeFrame: Baseline (Day 1) up to Month 12
measure: Indirect Cost Associated With Caregiver Burden
timeFrame: Baseline (Day 1) and Month 12
measure: Indirect Cost Associated With Quality of Life
timeFrame: Baseline (Day 1) and Month 12
Other outcomes:
Locations:
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: Fundacion para el Estudio y Tratamiento de las Enfermedades Mentales
city: Ciudad de Mendoza
country: Argentina
facility: CESASIN
city: Cordoba
country: Argentina
facility: Instituto DAMIC
city: La Plata
country: Argentina
facility: Clinica Privada de Salud Mental Santa Teresa de Ávila
city: Rosario
country: Argentina
facility: C I A P Centro de investigacion y Asistencia en Psiquiatria
city: Belo Horizonte
country: Brazil
facility: Universidade Federal De Minas Gerais - Hospital das Clínicas
city: Criciúma
country: Brazil
facility: Instituto De Neurociencias Dr. Quevedo Hospital Sao Sebastiao
city: Curitiba
country: Brazil
facility: Trial Tech Tecnologia em Pesquisas com Medicamentos
city: Fortaleza
country: Brazil
facility: Universidade Federal Do Ceara
city: Itapira
country: Brazil
facility: Instituto Bairral de Psiquiatria
city: Pelotas
country: Brazil
facility: Faculdade de Medicina da Universidade Federal de Pelotas
city: Porto Alegre
country: Brazil
facility: Hospital das Clinicas de Porto Alegre
city: Rio de Janeiro
country: Brazil
facility: Universidade Federal do Rio de Janeiro - Instituto de Psiquiatria
city: Salvador
country: Brazil
facility: Hospital Universitario Professor Edgar Santos
city: Sao Paulo
country: Brazil
facility: Hospital Das Clinicas Da Faculdade De Medicina Da USP
city: Bello
country: Colombia
facility: HOMO - ESE Hospital Mental de Antioquia
city: Bogota
country: Colombia
facility: Instituto Colombiano del Sistema Nervioso
city: Bogota
country: Colombia
facility: Centro de Investigaciones del Sistema Nervioso Grupo Cisne Ltda.
city: Medellín - Antioquia
country: Colombia
facility: Conciencia S.A.S
city: Ciudad de Mexico
country: Mexico
facility: Grupo de Estudios Médicos y familiares Carraci SC
city: Ciudad de Mexico
country: Mexico
facility: Estimulación Magnética Transcraneal de México S.C.
city: Ixtapaluca
country: Mexico
facility: Hospital Psiquiátrico Granja la Salud Tlazolteotl
city: Leon
country: Mexico
facility: Hospital Aranda de la Parra S A de C V
city: Mexico City
country: Mexico
facility: Hospital Psiquiatrico Fray Bernardino Alvarez
city: Mexico City
country: Mexico
facility: Instituto Nacional de Psiquiatria Ramon de la Fuente Muniz
city: Mexico city
country: Mexico
facility: Clínica de Neuropsiquiatría Tlatelolco ISSSTE
city: Mexico
country: Mexico
facility: Instituto Nacional de Neurología y Neurocirugía
city: Mexico
country: Mexico
facility: Privarte Practice of Dr. Javier Zambrano
city: Mexico
country: Mexico
facility: Instituto Jalisciense de Salud Mental
city: Monterrey
country: Mexico
facility: Centro para las Adicciones y Salud Mental S.A. de C.V.
city: Monterrey
country: Mexico
facility: cit NEUROPSIQUE
city: San Luis Potosi
country: Mexico
facility: Hospital Central Dr Ignacio Morones Prieto
city: Toluca
country: Mexico
facility: Clínica de Consulta Externa Alfredo del Mazo Vélez ISSEMyM
Study officials:
affiliation: Jannsen Cilag S.A.
name: Jannsen Cilag S.A. Clinical Trial
role: STUDY_DIRECTOR
References:
citation: 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.