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Treatment Resistant Depression in America Latina (TRAL)

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ClinicalTrials.gov Identifier: NCT03207282
Recruitment Status : Completed
First Posted : July 2, 2017
Last Update Posted : December 10, 2021
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease
Depressive Disorder, Treatment-Resistant

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Study Type : Observational
Actual Enrollment : 1539 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Treatment Resistant Depression in America Latina
Actual Study Start Date : September 27, 2017
Actual Primary Completion Date : November 25, 2019
Actual Study Completion Date : November 25, 2019

Resource links provided by the National Library of Medicine


Group/Cohort
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.



Primary Outcome Measures :
  1. 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.

  2. Healthcare Resource Utilization in TRD Participants [ Time Frame: Up to Month 12 ]
    Healthcare resources utilized in TRD participants will be estimated.


Secondary Outcome Measures :
  1. Demographic Characteristics of TRD Participants [ Time Frame: Baseline (Day 1) ]
    Demographic characteristics (such as age and gender) of TRD participants will be assessed at baseline.

  2. Number of Participants With Comorbid Conditions [ Time Frame: Baseline (Day 1) ]
    Comorbid conditions of TRD participants will be assessed at baseline.

  3. Treatment Patterns Over Time for TRD Participants [ Time Frame: Baseline (Day 1) up to Month 12 ]
    Treatment patterns of TRD participants will be assessed over time.

  4. Treatment Duration for MDD [ Time Frame: 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).

  5. Treatment Pattern for TRD Participants by Line [ Time Frame: 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.

  6. Sequence of Drugs [ Time Frame: Baseline (Day 1) up to Month 12 ]
    Sequence of drugs taken by TRD participants will be determined.

  7. Severity of Symptoms as Measured by Montgomery-Asberg Depression Rating Scale (MADRS) Score [ Time Frame: 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.

  8. Level of Disability as Measured by Sheehan Disability Scale (SDS) [ Time Frame: 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.

  9. 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 ]
    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.

  10. Healthcare Costs in TRD Participants [ Time Frame: Up to Month 12 ]
    Total healthcare costs and healthcare costs related to depression will be determined in TRD participants.

  11. Indirect Cost Associated With Work Productivity Loss [ Time Frame: 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.

  12. Indirect Cost Associated With Daily Functioning Loss [ Time Frame: Baseline (Day 1) up to Month 12 ]
    Indirect cost associated with daily functioning loss will be determined.

  13. Indirect Cost Associated With Caregiver Burden [ Time Frame: Baseline (Day 1) and Month 12 ]
    Indirect cost associated with caregiver burden will be determined.

  14. Indirect Cost Associated With Quality of Life [ Time Frame: 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).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03207282


Locations
Show Show 33 study locations
Sponsors and Collaborators
Janssen-Cilag, S.A.
Investigators
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Study Director: Jannsen Cilag S.A. Clinical Trial Jannsen Cilag S.A.
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Janssen-Cilag, S.A.
ClinicalTrials.gov Identifier: NCT03207282    
Other Study ID Numbers: CR108329
54135419RSD4001 ( Other Identifier: Jannsen Cilag S.A. )
First Posted: July 2, 2017    Key Record Dates
Last Update Posted: December 10, 2021
Last Verified: December 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Depressive Disorder
Depressive Disorder, Treatment-Resistant
Mood Disorders
Mental Disorders