Treatment Resistant Depression in America Latina

Study Overview
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Brief Summary
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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.

Official Title
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Treatment Resistant Depression in America Latina

Conditions
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Depressive Disorder, Treatment-Resistant

Participation Criteria
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Eligibility Criteria
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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: Adequate follow-up and treatment with at least 2 antidepressants 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Participants with Diagnosis of Depression<br>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 the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline (Day 1) | 
| Healthcare Resource Utilization in TRD Participants | Healthcare resources utilized in TRD participants will be estimated. | Up to Month 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Demographic Characteristics of TRD Participants | Demographic characteristics (such as age and gender) of TRD participants will be assessed at baseline. | Baseline (Day 1) | 
| Number of Participants With Comorbid Conditions | Comorbid conditions of TRD participants will be assessed at baseline. | Baseline (Day 1) | 
| Treatment Patterns Over Time for TRD Participants | Treatment patterns of TRD participants will be assessed over time. | 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). | 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. | Baseline (Day 1) up to Month 12 | 
| Sequence of Drugs | Sequence of drugs taken by TRD participants will be determined. | 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. | 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. | 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. | 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. | 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. | Baseline (Day 1) up to Month 12 | 
| Indirect Cost Associated With Daily Functioning Loss | Indirect cost associated with daily functioning loss will be determined. | Baseline (Day 1) up to Month 12 | 
| Indirect Cost Associated With Caregiver Burden | Indirect cost associated with caregiver burden will be determined. | 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). | Baseline (Day 1) and Month 12 |