Effects of Testosterone in Women With Depression

Condition(s) targeted: Depression

Intervention: Testosterone (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: Massachusetts General Hospital

Official(s) and/or principal investigator(s):
Karen K Miller, MD, Principal Investigator, Affiliation: Massachsuetts General Hospital

Overall contact:
Lindsay E. Gunnell, BS, Phone: 617-724-1579, Email: lgunnell@partners.org

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 SSRI-resistant depression.

However, testosterone administration in women with SSRI or SNRI-resistant depression has not been studied.

Official title: Effects of Testosterone in Women With Depression: A Pilot Study

Study design: Treatment, Open Label, Single Group Assignment, Efficacy Study

Primary outcome: MADRS score

Secondary outcome:

IDS-SR

ESS

FSS

PFSF

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Female.

Criteria:

Inclusion Criteria:

- Female, age 18-75

- Written informed consent

- Meet DSM-IV criteria (by SCID) for Major Depressive Disorder

- Meet DSM-IV criteria for a current major depressive episode, as assessed by SCID

- MADRS > or = 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, 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 (>50%) in the past year)

- Alanine aminotransferase (ALT) > 1. 5x upper limit of normal.

- Creatinine > 1. 5x upper limit of normal

- History of a hormone-responsive cancer

- History of congestive heart failure

- MADRS > 31

Lindsay E. Gunnell, BS, Phone: 617-724-1579, Email: lgunnell@partners.org

Depression Clinical and Research Program, Boston, Massachusetts 02114, United States; Recruiting
Roy Perlis, MD, Sub-Investigator

Starting date: March 2007
Last updated: May 8, 2008