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Effects of Testosterone in Women With Depression

Primary Purpose

Depression

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Testosterone
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring Depression, Major Depressive Disorder

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Active Comparator

    Arm Label

    Testosterone

    Arm Description

    Testosterone patch delivering 300mcg daily for 8-weeks.

    Outcomes

    Primary Outcome Measures

    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).

    Secondary Outcome Measures

    Full Information

    First Posted
    May 8, 2008
    Last Updated
    November 1, 2012
    Sponsor
    Massachusetts General Hospital
    Collaborators
    National Institutes of Health (NIH)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00676676
    Brief Title
    Effects of Testosterone in Women With Depression
    Official Title
    Effects of Testosterone in Women With Depression: A Pilot Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2012
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2007 (undefined)
    Primary Completion Date
    October 2008 (Actual)
    Study Completion Date
    October 2008 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Massachusetts General Hospital
    Collaborators
    National Institutes of Health (NIH)

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Depression
    Keywords
    Depression, Major Depressive Disorder

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    9 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Testosterone
    Arm Type
    Active Comparator
    Arm Description
    Testosterone patch delivering 300mcg daily for 8-weeks.
    Intervention Type
    Drug
    Intervention Name(s)
    Testosterone
    Intervention Description
    Testosterone atch delivering 300mcg daily for 8-weeks
    Primary Outcome Measure Information:
    Title
    Montgomery-Asberg Depression Rating Scale (MADRS) Scale
    Description
    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).
    Time Frame
    Baseline, 2-week, 8-week

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Karen K Miller, MD
    Organizational Affiliation
    Massachsuetts General Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Effects of Testosterone in Women With Depression

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