Status:
UNKNOWN
Integral Assessment in Unipolar Depression
Lead Sponsor:
University of Sao Paulo
Conditions:
Major Depressive Disorder
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
The objective of this project is to assess the occurrence of early improvement within the first two weeks of antidepressant treatment and to correlate this improvement with favorable therapeutic outco...
Detailed Description
An ongoing debate, as long-running as treatment with antidepressants itself, is the delay in response to these drugs. Antidepressant drugs take 2 to 4 weeks to produce the treatment response effect (a...
Eligibility Criteria
Inclusion
- Patients Presenting Depressive Episode according to DSM-IV-TR
Exclusion
- 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.
Key Trial Info
Start Date :
January 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2017
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT02268487
Start Date
January 1 2014
End Date
January 1 2017
Last Update
December 11 2015
Active Locations (1)
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1
Insitute of Psychiatry of the University of São Paulo
São Paulo, São Paulo, Brazil