Integral Assessment in Unipolar Depression

• Status: Unknown status
• Trial end date: 2017-01-01
• Target enrollment: 0
• Participant gender: All

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 outcome at the end of the acute and treatment continuation phases (8 and 24 weeks, respectively).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Sao Paulo
• Treatments: Sertraline

Criteria

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.