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Treatment Resistant Depression in America Latina (TRAL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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.

Tracking Information
First Submitted Date June 30, 2017
First Posted Date July 2, 2017
Last Update Posted Date December 10, 2021
Actual Study Start Date September 27, 2017
Actual Primary Completion Date November 25, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 30, 2017)
  • 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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: June 30, 2017)
  • 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.
  • Number of Participants With Comorbid Conditions [ Time Frame: Baseline (Day 1) ]
    Comorbid conditions of TRD participants will be assessed at baseline.
  • 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.
  • 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).
  • 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.
  • Sequence of Drugs [ Time Frame: Baseline (Day 1) up to Month 12 ]
    Sequence of drugs taken by TRD participants will be determined.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • Indirect Cost Associated With Caregiver Burden [ Time Frame: Baseline (Day 1) and Month 12 ]
    Indirect cost associated with caregiver burden will be determined.
  • 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).
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Treatment Resistant Depression in America Latina
Official Title Treatment Resistant Depression in America Latina
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Depressive Disorder, Treatment-Resistant
Intervention Not Provided
Study Groups/Cohorts 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.
Publications * Soares B, Kanevsky G, Teng CT, Pérez-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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: December 8, 2021)
1539
Original Estimated Enrollment
 (submitted: June 30, 2017)
387
Actual Study Completion Date November 25, 2019
Actual Primary Completion Date November 25, 2019   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Argentina,   Brazil,   Colombia,   Mexico
Removed Location Countries  
 
Administrative Information
NCT Number NCT03207282
Other Study ID Numbers CR108329
54135419RSD4001 ( Other Identifier: Jannsen Cilag S.A. )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Current Responsible Party Janssen-Cilag, S.A.
Original Responsible Party Same as current
Current Study Sponsor Janssen-Cilag, S.A.
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators
Study Director: Jannsen Cilag S.A. Clinical Trial Jannsen Cilag S.A.
PRS Account Janssen-Cilag, S.A.
Verification Date December 2021