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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. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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21 December 2015 |
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Main ID: |
NCT02268487 |
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Date of registration:
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08/10/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Integral Assessment in Unipolar Depression
AIUNI |
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Scientific title:
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THE AIUNI - Integral Assessment in Unipolar Depression |
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Date of first enrolment:
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January 2014 |
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Target sample size:
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100 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02268487 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 4
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Countries of recruitment
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Brazil
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Contacts
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Name:
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Moreno A Ricardo, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of São Paulo |
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Name:
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Fernando Fernandes, MD |
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Address:
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Telephone:
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+55 11 997810107 |
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Email:
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fernandes2000@gmail.com |
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Affiliation:
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Name:
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Fernando Fernandes, MD |
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Address:
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Telephone:
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+55 11 997810107 |
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Email:
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fernandes2000@gmail.com |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Patients Presenting Depressive Episode according to DSM-IV-TR
Exclusion Criteria:
- Patients presenting: psychotic symptoms, Axis 1 comorbidities (except specific
phobia, specific social phobia and nicotine dependence) or risk of suicide (defined
as score = 3 on item 3 of the 17-item HAMD or at the discretion of rater);
- Other exclusion criteria are having a serious or unstable medical condition,
including cardiovascular, hepatic, endocrinologic, neurological or renal conditions.
- Clinically significant abnormalities on laboratory or ECG exams or those which, in
the investigator ´s opinion, indicate a serious medical issue, require a major
intervention or may interfere in the antidepressant treatment, also constitute
grounds for exclusion.
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Major Depressive Disorder
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Intervention(s)
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Drug: Sertraline
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Primary Outcome(s)
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Early Improvement
[Time Frame: 2 Weeks]
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Secondary Outcome(s)
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Remission
[Time Frame: 8 and 24 weeks]
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Response
[Time Frame: 4 and 8 weeks]
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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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