Effects of Testosterone in Women With Depression - Full Text View

Purpose

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.

Condition	Intervention
Depression	Drug: Testosterone


Study Type:	Interventional
Study Design:	Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Effects of Testosterone in Women With Depression: A Pilot Study

Resource links provided by NLM:

Drug Information available for: Testosterone propionate Methyltestosterone Testosterone cypionate Testosterone Testosterone enanthate Testosterone undecanoate

U.S. FDA Resources

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:

Montgomery-Asberg Depression Rating Scale (MADRS) Scale [ Time Frame: Baseline, 2-week, 8-week ] [ Designated as safety issue: No ]
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).


Enrollment:	9
Study Start Date:	March 2007
Study Completion Date:	October 2008
Primary Completion Date:	October 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Testosterone Testosterone patch delivering 300mcg daily for 8-weeks.	Drug: Testosterone Testosterone atch delivering 300mcg daily for 8-weeks

Eligibility


Ages Eligible for Study:	18 Years to 75 Years (Adult, Senior)
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00676676

Sponsors and Collaborators

Massachusetts General Hospital

National Institutes of Health (NIH)

Investigators


Principal Investigator:	Karen K Miller, MD	Massachsuetts General Hospital

More Information


Responsible Party:	Karen Klahr Miller, MD, Principal Investigator, Massachusetts General Hospital
ClinicalTrials.gov Identifier:	NCT00676676 History of Changes
Other Study ID Numbers:	2007p000348
Study First Received:	May 8, 2008
Results First Received:	May 10, 2012
Last Updated:	November 1, 2012
Health Authority:	United States: Food and Drug Administration United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:


Depression Major Depressive Disorder

Additional relevant MeSH terms:


Depression Depressive Disorder Behavioral Symptoms Mood Disorders Mental Disorders Testosterone Testosterone enanthate Testosterone undecanoate Testosterone 17 beta-cypionate	Methyltestosterone Androgens Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Antineoplastic Agents, Hormonal Antineoplastic Agents Anabolic Agents

ClinicalTrials.gov processed this record on September 23, 2016