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Effects of Testosterone in Women With Depression

NCT00676676 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2012-11-30

Study results available
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Summary

The purpose of the study is to determine whether adding a low dose of testosterone to current antidepressant therapy improves depression and fatigue in women who remain depressed despite necessary adequate doses of anti-depressants. Testosterone will be given over an 8-week period.

Testosterone is a hormone that occurs naturally in the body. In women it comes from the ovaries and adrenal glands and is found in amounts that are ten to twenty times lower than in men.

In early research studies, testosterone has been shown to have some antidepressant effects in the following groups of subjects:

* Women with anorexia nervosa
* Women who have low testosterone levels because their pituitary glands do not work
* Men with Selective Serotonin Reuptake Inhibitor (SSRI)-resistant depression.

However, testosterone administration in women with SSRI or Serotonin-norepinephrine reuptake inhibitor (SNRI) -resistant depression has not been studied.

Conditions

Interventions

DRUG

Testosterone

Testosterone atch delivering 300mcg daily for 8-weeks

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

  • Massachusetts General Hospital

    lead OTHER

Principal Investigators

  • Karen K Miller, MD · Massachsuetts General Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-03-31
Primary Completion
2008-10-31
Completion
2008-10-31

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Entities

Diseases

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 NCT00676676 on ClinicalTrials.gov