Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Massachusetts General Hospital
With
National Institutes of Health (NIH)
Age
18–75
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible 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 be 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
