Effects of Testosterone in Women With Depression

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.

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Key information

Conditions

Depression Behavior Behavioral Symptoms Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Female, age 18-75
Written informed consent
Meet Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV) criteria (by Structured Clinical Interview for DSM-IV (SCID)) for Major Depressive Disorder
Meet DSM-IV criteria for a current major depressive episode, as assessed by SCID
Montgomery-Asberg Depression Rating Scale (MADRS) greater than or equal to 16 at baseline visit
Currently treated with SSRI or SNRI, with or without adjunctive therapy, at an adequate dose (see adequate dose table below) for at least six weeks

Exclusion criteria

Pregnant women or women of child bearing potential who are not using a medically accepted means of contraception (to include oral contraceptive or implant, condom, diaphragm, spermicide, intrauterine device, tubal ligation, or partner with vasectomy)
Serious suicide or homicide risk, as assessed by evaluating clinician
Unstable medical illness including cardiovascular, hepatic, renal, respiratory, endocrine, neurologic (including uncontrolled seizure disorder)
Substance use disorder active within last six months
Psychotic features (current episode or lifetime), as assessed by SCID
Laboratory evidence of untreated hypothyroidism
If treated hypothyroidism, significant change in levo-thyroxine dose within the prior three months
If receiving oral estrogen therapy, including oral contraceptives or transdermal estrogen therapy, significant change in dose in the prior three months
Use of androgens or androgen precursors, including testosterone, Dehydroepiandrosterone (DHEA) and methyltestosterone, within the prior three months
Any investigational psychotropic drug within the last two weeks
In the judgment of the study clinician, unlikely to be able to participate safely throughout the study period (three or more episodes of self-harm in the past year, documented history of poor treatment adherence, or frequent missed appointments (greater than 50%) in the past year)
Alanine aminotransferase (ALT) greater than 1.5 times the upper limit of normal.
Creatinine greater than 1.5 times upper limit of normal
History of a hormone-responsive cancer
History of congestive heart failure
MADRS greater than 31

Treatment and study plan

Testosterone

Drug

Testosterone atch delivering 300mcg daily for 8-weeks

Primary outcomes

Montgomery-Asberg Depression Rating Scale (MADRS) Scale

Time frame: Baseline, 2-week, 8-week

the MADRS is a diagnostic questionnaire that is used to measure the severity of depressive episodes in patients with mood disorders. The minimum and maximum values are 0 and 60 respectively (higher scores are more severe).

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

National Institutes of Health (NIH)

Registry information

Official study title

Effects of Testosterone in Women With Depression: A Pilot Study

Important dates

Study start: 2007
Primary completion: 2008
Study completion: 2008
First posted: May 13, 2008
Registry last updated: Nov 30, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed