TRAL: Treatment Resistant Depression in America Latina

• Sponsor: Janssen-Cilag, S.A. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03207282
• Collaborator: (none)
• Enrollment: 1,539
• Locations: 33
• Actual Duration (Months): 25.9
• Patients Per Site: 46.6
• Patients Per Site Per Month: 1.8

Study Details

Study Description

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	Intervention/Treatment	Phase
Depressive Disorder, Treatment-Resistant

Study Design

• 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: Sep 27, 2017
• Actual Primary Completion Date: Nov 25, 2019
• Actual Study Completion Date: Nov 25, 2019

Arms and Interventions

Arm

Intervention/Treatment

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.

Outcome Measures

Primary Outcome Measures

1. 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.

2. Healthcare Resource Utilization in TRD Participants [Up to Month 12]

   Healthcare resources utilized in TRD participants will be estimated.

Secondary Outcome Measures

1. Demographic Characteristics of TRD Participants [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 [Baseline (Day 1)]

   Comorbid conditions of TRD participants will be assessed at baseline.

3. Treatment Patterns Over Time for TRD Participants [Baseline (Day 1) up to Month 12]

   Treatment patterns of TRD participants will be assessed over time.

4. 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).

5. 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.

6. Sequence of Drugs [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 [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) [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 [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 [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 [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 [Baseline (Day 1) up to Month 12]

    Indirect cost associated with daily functioning loss will be determined.

13. Indirect Cost Associated With Caregiver Burden [Baseline (Day 1) and Month 12]

    Indirect cost associated with caregiver burden will be determined.

14. 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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fundación para el Estudio y Tratamiento de las Enfermedades Mentales	Ciudad Autonoma de Buenos Aires		Argentina	C1425AHQ
2	CESASIN	Ciudad de Mendoza		Argentina	5500
3	Instituto DAMIC	Cordoba		Argentina	X5003DCE
4	Clinica Privada de Salud Mental Santa Teresa de Ávila	La Plata		Argentina	B1904ADM
5	C.I.A.P. (Centro de investigación y Asistencia en Psiquiatría)	Rosario		Argentina	2000
6	Hospital Universitario Professor Edgar Santos	Bahia		Brazil	40110-060
7	Hospital Das Clinicas Da Universidade Federal De Minas Gerais	Belo Horizonte		Brazil	301301
8	Instituto De Neurociencias Dr. Quevedo Hospital Sao Sebastiao	Criciúma		Brazil	88801-250
9	Trial Tech Tecnologia em Pesquisas com Medicamentos	Curitiba		Brazil	80240-280
10	Universidade Federal Do Ceara	Fortaleza		Brazil	60430-370
11	Instituto Bairral de Psiquiatria	Itapira		Brazil	13970-905
12	Faculdade de Medicina da Universidade Federal de Pelotas	Pelotas		Brazil	96030-002
13	Hospital de Clínicas de Porto Alegre	Porto Alegre		Brazil	90035-903
14	UFRJ - Instituto de Psiquiatria	Rio de Janeiro		Brazil	22290-140
15	Instituto de Psiquiatria - Hcfmusp	Sao Paulo		Brazil	05403-903
16	HOMO - ESE Hospital Mental de Antioquia	Bello		Colombia	051053
17	Instituto Colombiano del Sistema Nervioso	Bogota		Colombia	110121
18	Centro de Investigaciones del Sistema Nervioso Grupo Cisne Ltda.	Bogotá		Colombia	111166
19	Conciencia S.A.S	Medellín - Antioquia		Colombia	050021
20	Grupo de Estudios Médicos y familiares Carraci SC	Ciudad de Mexico		Mexico	03740
21	Estimulación Magnética Transcraneal de México S.C.	Ciudad de Mexico		Mexico	11006
22	Hospital Psiquiátrico Granja la Salud Tlazolteotl	Ixtapaluca		Mexico	56530
23	Hospital Aranda de la Parra S.A. de C.V.	Leon		Mexico	37000
24	Hospital Psiquiatrico Fray Bernardino Alvarez	Mexico City		Mexico	14000
25	Instituto Nacional de Psiquiatría 'Ramón de la Fuente Muñiz'	Mexico City		Mexico	14370
26	Clínica de Neuropsiquiatría Tlatelolco ISSSTE	Mexico city		Mexico	6900
27	Instituto Nacional de Neurología y Neurocirugía	Mexico		Mexico	14269
28	Privarte Practice of Dr. Javier Zambrano	Mexico		Mexico	15900
29	Instituto Jalisciense de Salud Mental	Mexico		Mexico	45170
30	Centro para las Adicciones y Salud Mental S.A. de C.V.	Monterrey		Mexico	64060
31	cit NEUROPSIQUE	Monterrey		Mexico	64610
32	Hospital Central Dr Ignacio Morones Prieto	San Luis Potosi		Mexico	78240
33	Clínica de Consulta Externa Alfredo del Mazo Vélez ISSEMyM	Toluca		Mexico	50080

Sponsors and Collaborators

• Janssen-Cilag, S.A.

Investigators

• Study Director: Jannsen Cilag S.A. Clinical Trial, Jannsen Cilag S.A.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Janssen-Cilag, S.A.
• ClinicalTrials.gov Identifier: NCT03207282
• Other Study ID Numbers: CR108329; 54135419RSD4001
• First Posted: Jul 2, 2017
• Last Update Posted: Dec 10, 2021
• Last Verified: Dec 1, 2021

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

Study Results

No Results Posted as of Dec 10, 2021