Selenium as Augmentation Treatment for Sertraline Resistant Major Depression
NCT02890212 · Status: SUSPENDED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60
Last updated 2024-05-28
Summary
The main goals of antidepressant treatments are to achieve remission of depressive episodes and prevent recurrences. However, clinical trials designed to approve antidepressants targets a response rate of at least 50%, which is considered partially effective. Therefore, there is a need for new treatment strategies, including augmentation with other substances such as lithium. This research aims to verify through a pilot study, the effect of selenium as an augmentation treatment for sertraline-resistant major depression. This clinical trial was designed to be a randomized, placebo-controlled, double-blind trial evaluating the effect of selenium or placebo in subjects diagnosed with major depression who have not responded to treatment with sertraline
Conditions
Interventions
- DIETARY_SUPPLEMENT
-
selenium supplementation
administration of selenium pills (400 micrograms) for randomized subjects
- DIETARY_SUPPLEMENT
-
placebo
administration of placebo pills for randomized subjects
Sponsors & Collaborators
-
University of Sao Paulo General Hospital
lead OTHER
Principal Investigators
-
Teng C. Tung, M. D.,Ph. D. · Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2005-08-31
- Primary Completion
- 2025-12-31
- Completion
- 2025-12-31
Countries
- Brazil
Study Locations
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