Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
1539 participants
OBSERVATIONAL
2017-09-27
2019-11-25
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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 with substance dependence considered serious by the investigator
* Participant currently participating in another clinical study
18 Years
ALL
No
Sponsors
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Janssen-Cilag, S.A.
INDUSTRY
Responsible Party
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Principal Investigators
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Jannsen Cilag S.A. Clinical Trial
Role: STUDY_DIRECTOR
Jannsen Cilag S.A.
Locations
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Fundacion para el Estudio y Tratamiento de las Enfermedades Mentales
Buenos Aires, , Argentina
Instituto DAMIC
Córdoba, , Argentina
Clinica Privada de Salud Mental Santa Teresa de Ávila
La Plata, , Argentina
CESASIN
Mendoza, , Argentina
C I A P Centro de investigacion y Asistencia en Psiquiatria
Rosario, , Argentina
Universidade Federal De Minas Gerais - Hospital das Clínicas
Belo Horizonte, , Brazil
Instituto De Neurociencias Dr. Quevedo Hospital Sao Sebastiao
Criciúma, , Brazil
Trial Tech Tecnologia em Pesquisas com Medicamentos
Curitiba, , Brazil
Universidade Federal Do Ceara
Fortaleza, , Brazil
Instituto Bairral de Psiquiatria
Itapira, , Brazil
Faculdade de Medicina da Universidade Federal de Pelotas
Pelotas, , Brazil
Hospital das Clinicas de Porto Alegre
Porto Alegre, , Brazil
Universidade Federal do Rio de Janeiro - Instituto de Psiquiatria
Rio de Janeiro, , Brazil
Hospital Universitario Professor Edgar Santos
Salvador, , Brazil
Hospital Das Clinicas Da Faculdade De Medicina Da USP
São Paulo, , Brazil
HOMO - ESE Hospital Mental de Antioquia
Bello, , Colombia
Instituto Colombiano del Sistema Nervioso
Bogotá, , Colombia
Centro de Investigaciones del Sistema Nervioso Grupo Cisne Ltda.
Bogotá, , Colombia
Conciencia S.A.S
Medellín - Antioquia, , Colombia
Hospital Psiquiátrico Granja la Salud Tlazolteotl
Ixtapaluca, , Mexico
Hospital Aranda de la Parra S A de C V
León, , Mexico
Grupo de Estudios Médicos y familiares Carraci SC
Mexico City, , Mexico
Estimulación Magnética Transcraneal de México S.C.
Mexico City, , Mexico
Hospital Psiquiatrico Fray Bernardino Alvarez
Mexico City, , Mexico
Instituto Nacional de Psiquiatria Ramon de la Fuente Muniz
Mexico City, , Mexico
Clínica de Neuropsiquiatría Tlatelolco ISSSTE
Mexico City, , Mexico
Instituto Nacional de Neurología y Neurocirugía
México, , Mexico
Privarte Practice of Dr. Javier Zambrano
México, , Mexico
Instituto Jalisciense de Salud Mental
México, , Mexico
Centro para las Adicciones y Salud Mental S.A. de C.V.
Monterrey, , Mexico
cit NEUROPSIQUE
Monterrey, , Mexico
Hospital Central Dr Ignacio Morones Prieto
San Luis Potosí City, , Mexico
Clínica de Consulta Externa Alfredo del Mazo Vélez ISSEMyM
Toluca, , Mexico
Countries
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References
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Soares B, Kanevsky G, Teng CT, Perez-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.
Other Identifiers
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54135419RSD4001
Identifier Type: OTHER
Identifier Source: secondary_id
CR108329
Identifier Type: -
Identifier Source: org_study_id
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