Depressive Disorder, Treatment-Resistant
Conditions
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.
Interventions
None listed
Sponsors
Janssen-Cilag, S.A.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Treatment Resistant Depression (TRD) | 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 | Up to Month 12 | Healthcare resources utilized in TRD participants will be estimated. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Comorbid Conditions | Baseline (Day 1) | Comorbid conditions of TRD participants will be assessed at baseline. |
| Treatment Patterns Over Time for TRD Participants | Baseline (Day 1) up to Month 12 | Treatment patterns of TRD participants will be assessed over time. |
| Treatment Duration for MDD | 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 | 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 | 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 | 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. |
| Indirect Cost Associated With Daily Functioning Loss | Baseline (Day 1) up to Month 12 | Indirect cost associated with daily functioning loss will be determined. |
| Suicidality Risk (Ideation and Attempts) as Measured by Columbia-Suicide Severity Rating Scale (C-SSRS) Score | 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 | 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 | 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 Caregiver Burden | Baseline (Day 1) and Month 12 | Indirect cost associated with caregiver burden will be determined. |
| Indirect Cost Associated With Quality of Life | 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). |
| Level of Disability as Measured by Sheehan Disability Scale (SDS) | 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. |
| Demographic Characteristics of TRD Participants | Baseline (Day 1) | Demographic characteristics (such as age and gender) of TRD participants will be assessed at baseline. |
Countries
Argentina, Brazil, Colombia, Mexico
Outcome results
None listed