Selenium as Augmentation Treatment for Sertraline Resistant Major Depression

NCT02890212 | Suspended

• 1 other identifier: Selen-2015
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Major Depression

Keywords

Major depression, selenium, placebo, sertraline

Outcome Measures

Primary Outcomes (1)

• Hamilton Depressive Rating Scale

  6 weeks

Secondary Outcomes (2)

• Montgomery-Asberg Depression Rating Scale

  6 weeks

• Clinical Global Impression Scale

  6 weeks

Study Arms (2)

selenium

EXPERIMENTAL

subjects resistant to treatment of major depression with sertraline who were randomized and ingest selenium pills (400 microgram) during six weeks

Dietary Supplement: selenium supplementation

placebo

PLACEBO COMPARATOR

subjects resistant to treatment of major depression with sertraline who were randomized and ingest placebo pills

Dietary Supplement: placebo

Interventions

selenium supplementation DIETARY_SUPPLEMENT

administration of selenium pills (400 micrograms) for randomized subjects

selenium

placebo DIETARY_SUPPLEMENT

administration of placebo pills for randomized subjects

placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• of both genders
• over the age of 18 years
• in outpatient care
• who meet the diagnostic criteria for major depression by the DSM-IV, confirmed by the application of structured interview SCID,
• with scores higher than 17 on the Hamilton scale of 17 items for depression
• who agree to participate voluntarily in the study, after full and unrestricted information about the study to be performed, as documented by signing the informed consent
• Women of childbearing age need negative pregnancy test in the pre-assessment tests, and must use prevention of pregnancy during treatment.

You may not qualify if:

• have a known sensitivity to sertraline or selenium
• have psychiatric hospitalization indication, due to the presence of any psychiatric condition that would justify the hospitalization, including patients with severe risk of suicide.
• have history of resistance to sertraline treatment, in clinical effective doses and for appropriate duration (at least 100 mg for at least 8 weeks).
• have any psychosis (including diagnostic ICD10 F20-29, F06.0-06.2, F32.3 and F33.3), bipolar disorder or personality disorder
• have received monoamine oxidase inhibitors 14 days prior to selection
• show clinical diseases that require the use of medications that can interact with sertraline.
• known or suspected pregnancy.
• breast-feeding women.
• Use of any drug that has known and relevant psychopharmacological action, despite not having preferential psychotropic drug use, unless it has been used with a stable dose for at least a month.
• have dependency on any psychoactive substance in the last 12 months (except caffeine and tobacco).
• Presence of an unstable disease that compromises the outcome (eg. Lupus Erythematosus, decompensated diabetes mellitus, cardiac insufficiency) that will determined clinically by the investigator.

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Study Sites (1)

Instituto de Psiquiatria - Hcfmusp

São Paulo, 005403-010, Brazil

Location

Related Publications (6)

• Ferrier IN. Treatment of major depression: is improvement enough? J Clin Psychiatry. 1999;60 Suppl 6:10-4.

  PMID: 10235119 BACKGROUND

• McIntyre RS, O'Donovan C. The human cost of not achieving full remission in depression. Can J Psychiatry. 2004 Mar;49(3 Suppl 1):10S-16S.

  PMID: 15147032 BACKGROUND

• Joffe RT, Levitt AJ. Relationship between antidepressant partial and nonresponse and subsequent response to antidepressant augmentation. J Affect Disord. 1999 Jan-Mar;52(1-3):257-9. doi: 10.1016/s0165-0327(97)00178-x.

  PMID: 10357043 BACKGROUND

• Aronson R, Offman HJ, Joffe RT, Naylor CD. Triiodothyronine augmentation in the treatment of refractory depression. A meta-analysis. Arch Gen Psychiatry. 1996 Sep;53(9):842-8. doi: 10.1001/archpsyc.1996.01830090090013.

  PMID: 8792761 BACKGROUND

• Rayman MP. The importance of selenium to human health. Lancet. 2000 Jul 15;356(9225):233-41. doi: 10.1016/S0140-6736(00)02490-9.

  PMID: 10963212 BACKGROUND

• Hawkes WC, Hornbostel L. Effects of dietary selenium on mood in healthy men living in a metabolic research unit. Biol Psychiatry. 1996 Jan 15;39(2):121-8. doi: 10.1016/0006-3223(95)00085-2.

  PMID: 8717610 BACKGROUND

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Teng C. Tung, M. D.,Ph. D.

  Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M. D. , Ph. D.

Study Record Dates

• First Submitted: June 24, 2016
• First Posted: September 7, 2016
• Study Start: August 1, 2005
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: May 28, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)