Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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21 December 2021 |
Main ID: |
NCT03207282 |
Date of registration:
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30/06/2017 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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Treatment Resistant Depression in America Latina
TRAL |
Scientific title:
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Treatment Resistant Depression in America Latina |
Date of first enrolment:
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September 27, 2017 |
Target sample size:
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1539 |
Recruitment status: |
Completed |
URL:
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https://clinicaltrials.gov/show/NCT03207282 |
Study type:
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Observational |
Study design:
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Phase:
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Countries of recruitment
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Argentina
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Brazil
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Colombia
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Mexico
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Contacts
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Name:
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Jannsen Cilag S.A. Clinical Trial |
Address:
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Telephone:
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Email:
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Affiliation:
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Jannsen Cilag S.A. |
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Key inclusion & exclusion 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:
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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Depressive Disorder, Treatment-Resistant
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Primary Outcome(s)
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Healthcare Resource Utilization in TRD Participants
[Time Frame: Up to Month 12]
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Percentage of Participants With Treatment Resistant Depression (TRD)
[Time Frame: Baseline (Day 1)]
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Secondary Outcome(s)
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Indirect Cost Associated With Work Productivity Loss
[Time Frame: Baseline (Day 1) up to Month 12]
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Number of Participants With Comorbid Conditions
[Time Frame: Baseline (Day 1)]
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Level of Disability as Measured by Sheehan Disability Scale (SDS)
[Time Frame: Baseline (Day 1), Month 6, and 12]
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Treatment Duration for MDD
[Time Frame: Baseline (Day 1) up to Month 12]
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Indirect Cost Associated With Daily Functioning Loss
[Time Frame: Baseline (Day 1) up to Month 12]
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Severity of Symptoms as Measured by Montgomery-Asberg Depression Rating Scale (MADRS) Score
[Time Frame: Baseline (Day 1), Month 3, 6, 9 and 12]
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Treatment Pattern for TRD Participants by Line
[Time Frame: Baseline (Day 1) up to Month 12]
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Sequence of Drugs
[Time Frame: Baseline (Day 1) up to Month 12]
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Treatment Patterns Over Time for TRD Participants
[Time Frame: Baseline (Day 1) up to Month 12]
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Demographic Characteristics of TRD Participants
[Time Frame: Baseline (Day 1)]
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Healthcare Costs in TRD Participants
[Time Frame: Up to Month 12]
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Indirect Cost Associated With Quality of Life
[Time Frame: Baseline (Day 1) and Month 12]
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Indirect Cost Associated With Caregiver Burden
[Time Frame: Baseline (Day 1) and Month 12]
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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]
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Secondary ID(s)
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CR108329
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54135419RSD4001
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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