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Depressive Disorder, Treatment-ResistantTRALNCT03207282

Treatment Resistant Depression in America Latina

An observational study of Depressive Disorder, Treatment-Resistant, run by Janssen-Cilag, S.A. at 33 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Depressive Disorder, Treatment-Resistant
How many people
1,539 participants
Where
33 sitesin 4 countries
Study dates
27 Sep 2017to 25 Nov 2019
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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:
Show all 9Show fewer
  • Diagnosis of Treatment Resistant Depression (TRD), to be described by the investigator, based on the criteria:
  • Adequate follow-up and treatment with at least 2 antidepressants
  • Without complete response to treatment (based on Montgomery-Asberg Depression Rating Scale [MADRS])

Who cannot join

  • 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

Trial locations and contacts

33 sites in 4 countries.

33 sites in 4 countries

Mexico14 sites
  • Hospital Psiquiátrico Granja la Salud Tlazolteotl

    Ixtapaluca, 56530

  • Hospital Aranda de la Parra S A de C V

    León, 37000

  • Instituto Nacional de Neurología y Neurocirugía

    México, 14269

  • Privarte Practice of Dr. Javier Zambrano

    México, 15900

  • Instituto Jalisciense de Salud Mental

    México, 45170

  • Grupo de Estudios Médicos y familiares Carraci SC

    Mexico City, 03740

  • Estimulación Magnética Transcraneal de México S.C.

    Mexico City, 11006

  • Hospital Psiquiatrico Fray Bernardino Alvarez

    Mexico City, 14000

  • Instituto Nacional de Psiquiatria Ramon de la Fuente Muniz

    Mexico City, 14370

  • Clínica de Neuropsiquiatría Tlatelolco ISSSTE

    Mexico City, 6900

  • Centro para las Adicciones y Salud Mental S.A. de C.V.

    Monterrey, 64060

  • cit NEUROPSIQUE

    Monterrey, 64610

  • Hospital Central Dr Ignacio Morones Prieto

    San Luis Potosí City, 78240

  • Clínica de Consulta Externa Alfredo del Mazo Vélez ISSEMyM

    Toluca, 50080

Other trials in Mexico

Brazil10 sites
  • Universidade Federal De Minas Gerais - Hospital das Clínicas

    Belo Horizonte, 30130-100

  • Instituto De Neurociencias Dr. Quevedo Hospital Sao Sebastiao

    Criciúma, 88801-250

  • Trial Tech Tecnologia em Pesquisas com Medicamentos

    Curitiba, 80240-280

  • Universidade Federal Do Ceara

    Fortaleza, 60020-181

  • Instituto Bairral de Psiquiatria

    Itapira, 13970-905

  • Faculdade de Medicina da Universidade Federal de Pelotas

    Pelotas, 96030-002

  • Hospital das Clinicas de Porto Alegre

    Porto Alegre, 90035-903

  • Universidade Federal do Rio de Janeiro - Instituto de Psiquiatria

    Rio de Janeiro, 22290-140

  • Hospital Universitario Professor Edgar Santos

    Salvador, 40110-060

  • Hospital Das Clinicas Da Faculdade De Medicina Da USP

    São Paulo, 05403-903

Other trials in Brazil

Argentina5 sites
  • Fundacion para el Estudio y Tratamiento de las Enfermedades Mentales

    Buenos Aires, C1425AHQ

  • Instituto DAMIC

    Córdoba, X5003DCE

  • Clinica Privada de Salud Mental Santa Teresa de Ávila

    La Plata, B1904ADM

  • CESASIN

    Mendoza, 5500

  • C I A P Centro de investigacion y Asistencia en Psiquiatria

    Rosario, 2000

Other trials in Argentina

Colombia4 sites
  • HOMO - ESE Hospital Mental de Antioquia

    Bello, 051053

  • Instituto Colombiano del Sistema Nervioso

    Bogotá, 110121

  • Centro de Investigaciones del Sistema Nervioso Grupo Cisne Ltda.

    Bogotá, 111166

  • Conciencia S.A.S

    Medellín - Antioquia, 050021

Other trials in Colombia

About this study

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.

Medical subject headings
Depressive Disorder, Treatment-Resistant

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT03207282
Study groupRoleWhat they receive
Participants with Diagnosis of DepressionStudy 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 being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline (Day 1)

  2. Healthcare Resource Utilization in TRD Participants

    Healthcare resources utilized in TRD participants will be estimated.

    Measured: Up to Month 12

Secondary outcomes (14)
  1. Demographic Characteristics of TRD Participants

    Demographic characteristics (such as age and gender) of TRD participants will be assessed at baseline.

    Measured: Baseline (Day 1)

  2. Number of Participants With Comorbid Conditions

    Comorbid conditions of TRD participants will be assessed at baseline.

    Measured: Baseline (Day 1)

  3. Treatment Patterns Over Time for TRD Participants

    Treatment patterns of TRD participants will be assessed over time.

    Measured: Baseline (Day 1) up to Month 12

  4. 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).

    Measured: Baseline (Day 1) up to Month 12

  5. 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.

    Measured: Baseline (Day 1) up to Month 12

  6. Sequence of Drugs

    Sequence of drugs taken by TRD participants will be determined.

    Measured: Baseline (Day 1) up to Month 12

  7. 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.

    Measured: Baseline (Day 1), Month 3, 6, 9 and 12

  8. 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.

    Measured: Baseline (Day 1), Month 6, and 12

  9. 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.

    Measured: Baseline (Day 1), Month 3, 6, 9, and 12

  10. Healthcare Costs in TRD Participants

    Total healthcare costs and healthcare costs related to depression will be determined in TRD participants.

    Measured: Up to Month 12

  11. 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.

    Measured: Baseline (Day 1) up to Month 12

  12. Indirect Cost Associated With Daily Functioning Loss

    Indirect cost associated with daily functioning loss will be determined.

    Measured: Baseline (Day 1) up to Month 12

  13. Indirect Cost Associated With Caregiver Burden

    Indirect cost associated with caregiver burden will be determined.

    Measured: Baseline (Day 1) and Month 12

  14. 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).

    Measured: Baseline (Day 1) and Month 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jul 2017
  2. Study start27 Sep 2017
  3. Primary completion25 Nov 2019
  4. Study completion25 Nov 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,539 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03207282
Sponsor's protocol ID
CR108329
Other IDs
54135419RSD4001
Acronym
TRAL
Status last verified
Apr 2025
First submitted
30 Jun 2017
Last updated
27 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

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.

    PubMed 34463905

Questions about this trial

What is this clinical trial studying?

An observational study of Depressive Disorder, Treatment-Resistant, run by Janssen-Cilag, S.A. at 33 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 33 sites in Mexico, Brazil, Argentina, Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With Treatment Resistant Depression (TRD) (time frame: Baseline (Day 1)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03207282, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2025.

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