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.
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
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
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
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
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.
- Conditions
- Depressive Disorder, Treatment-Resistant
- 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 group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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)
Healthcare Resource Utilization in TRD Participants
Healthcare resources utilized in TRD participants will be estimated.
Measured: Up to Month 12
Secondary outcomes (14)
Demographic Characteristics of TRD Participants
Demographic characteristics (such as age and gender) of TRD participants will be assessed at baseline.
Measured: Baseline (Day 1)
Number of Participants With Comorbid Conditions
Comorbid conditions of TRD participants will be assessed at baseline.
Measured: Baseline (Day 1)
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
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
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
Sequence of Drugs
Sequence of drugs taken by TRD participants will be determined.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline (Day 1) up to Month 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
Indirect Cost Associated With Caregiver Burden
Indirect cost associated with caregiver burden will be determined.
Measured: 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).
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.
- First posted2 Jul 2017
- Study start27 Sep 2017
- Primary completion25 Nov 2019
- Study completion25 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Depressive Disorder, Treatment-ResistantStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Janssen-Cilag, S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jannsen Cilag S.A. Clinical Trial, Study director, Jannsen Cilag S.A.
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
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment Resistant Depression in America Latina
- ClinicalTrials.gov ID
- NCT03207282
- Acronym / sponsor ID
- TRAL / CR108329
- Conditions
- Depressive Disorder, Treatment-Resistant
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,539 participants (actual)
- Lead sponsor
- Janssen-Cilag, S.A.Industry (pharma, biotech, devices)
- Study start
- 27 Sep 2017 (actual)
- Primary completion
- 25 Nov 2019 (actual)
- Study completion
- 25 Nov 2019 (actual)
- First posted
- 2 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (9 listed)
- 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
- Diagnosis of Treatment Resistant Depression (TRD), to be described by the investigator, based on the criteria:
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Percentage of Participants With Treatment Resistant Depression (TRD)
Time frame: Baseline (Day 1)
Prevalence of TRD will be assessed as percentage of participants with TRD among Major Depressive Disorder (MDD) participants.
Healthcare Resource Utilization in TRD Participants
Time frame: Up to Month 12
Healthcare resources utilized in TRD participants will be estimated.
14 secondary outcomes
Demographic Characteristics of TRD Participants
Time frame: Baseline (Day 1)
Number of Participants With Comorbid Conditions
Time frame: Baseline (Day 1)
Treatment Patterns Over Time for TRD Participants
Time frame: Baseline (Day 1) up to Month 12
Treatment Duration for MDD
Time frame: Baseline (Day 1) up to Month 12
Treatment Pattern for TRD Participants by Line
Time frame: Baseline (Day 1) up to Month 12
Sequence of Drugs
Time frame: Baseline (Day 1) up to Month 12
Severity of Symptoms as Measured by Montgomery-Asberg Depression Rating Scale (MADRS) Score
Time frame: Baseline (Day 1), Month 3, 6, 9 and 12
Level of Disability as Measured by Sheehan Disability Scale (SDS)
Time frame: Baseline (Day 1), Month 6, and 12
Suicidality Risk (Ideation and Attempts) as Measured by Columbia-Suicide Severity Rating Scale (C-SSRS) Score
Time frame: Baseline (Day 1), Month 3, 6, 9, and 12
Healthcare Costs in TRD Participants
Time frame: Up to Month 12
Indirect Cost Associated With Work Productivity Loss
Time frame: Baseline (Day 1) up to Month 12
Indirect Cost Associated With Daily Functioning Loss
Time frame: Baseline (Day 1) up to Month 12
Indirect Cost Associated With Caregiver Burden
Time frame: Baseline (Day 1) and Month 12
Indirect Cost Associated With Quality of Life
Time frame: Baseline (Day 1) and Month 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2025.
- Derived from this study: PubMed 34463905Soares 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.
Related trials for Depressive Disorder, Treatment-Resistant
RecruitingPhase 4
Biomarker-Guided Antidepressant Selection
Depression - Major Depressive Disorder, Treatment-resistant Depression (TRD)
RecruitingPhase 2
ACP-211 Monotherapy for Major Depressive Disorder With Inadequate Antidepressant Response
Major Depressive Disorder (MDD), Depressive Disorder, Treatment-Resistant
Active, not recruiting
CET- REM (Correlating ECT Response to EEG Markers)
ECT, Treatment Resistant Depression
Active, not recruiting
rTMS to Target Neural Connectivity and Rumination in Treatment-Resistant Depression
Depression, Treatment Resistant
Recruiting
A Prospective, Multi-center, Randomized Controlled Blinded Trial Demonstrating the Safety and Effectiveness of VNS Therapy® System as Adjunctive Therapy Versus a No Stimulation Control in Subjects With Treatment-Resistant Depression
Treatment Resistant Depression
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jannsen Cilag S.A. Clinical Trial study director
Jannsen Cilag S.A.
33 sites in 4 countries: see every site and its status.
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.