Effects of Testosterone in Women With Depression

NCT00676676 | Completed Results DMC

• 1 other identifier: 2007p000348
• Study Type: interventional
• Target: 9
• Locations: 0 countries
• Sites: N/A

Brief 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

Depression

Keywords

Depression; Major Depressive Disorder

Outcome Measures

Primary Outcomes (1)

• Montgomery-Asberg Depression Rating Scale (MADRS) Scale

  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).

  Baseline, 2-week, 8-week

Study Arms (1)

Testosterone

ACTIVE COMPARATOR

Testosterone patch delivering 300mcg daily for 8-weeks.

Drug: Testosterone

Interventions

Testosterone DRUG

Testosterone atch delivering 300mcg daily for 8-weeks

Testosterone

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• National Institutes of Health (NIH): collaborator

MeSH Terms

Conditions

Depression; Depressive Disorder, Major

Interventions

Testosterone

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Androstenols; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Testosterone Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Results Point of Contact

• Title: Dr. Karen K. Miller
• Organization: Massachusetts General Hospita

kkmiller@partners.org

617-726-3870

Study Officials

• Karen K Miller, MD

  Massachsuetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 8, 2008
• First Posted: May 13, 2008
• Study Start: March 1, 2007
• Primary Completion: October 1, 2008
• Study Completion: October 1, 2008
• Last Updated: November 30, 2012
• Results First Posted: November 30, 2012

Record last verified: 2012-11