Effects of Testosterone in Women With Depression

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Karen Klahr Miller, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00676676
First received: May 8, 2008
Last updated: November 1, 2012
Last verified: November 2012
  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:


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
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
Investigators
Principal Investigator: Karen K Miller, MD Massachsuetts General Hospital
  More Information

No publications provided

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
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Anabolic Agents

ClinicalTrials.gov processed this record on September 16, 2014