Selenium as Augmentation Treatment for Sertraline Resistant Major Depression

NCT02890212 · Status: SUSPENDED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2024-05-28

No results posted yet for this study

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02890212 on ClinicalTrials.gov