Effects of Testosterone in Women With Depression
Primary Purpose
Depression
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Testosterone
Sponsored by
About this trial
This is an interventional treatment trial for Depression focused on measuring Depression, Major Depressive Disorder
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
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
NCT ID
NCT00676676
First Posted
May 8, 2008
Last Updated
November 1, 2012
Sponsor
Massachusetts General Hospital
Collaborators
National Institutes of Health (NIH)
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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