Hormonal Factors in the Treatment of Anorexia Nervosa

Mass General Brigham

Status and phase

Completed

Phase 2

Conditions

Eating Disorder

Anorexia Nervosa

Depression

Anxiety

Treatments

Drug: Testosterone

Drug: Placebo

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT01121211

2009P-001845/1

5R01MH083657-05A2 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

The investigators are investigating whether a hormone that is naturally produced by the human body, called testosterone, can help improve weight, disordered eating, depression, and anxiety. The investigators hypothesize that testosterone will be a novel and effective endocrine-targeted therapy for patients with anorexia nervosa.

Enrollment

90 patients

Sex

Female

Ages

18 to 45 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Age 18- 45 years; if participating in the neuroimaging sub study, age 18-40
Meet DSM-IV criteria for AN (restricting or binge/purge type, BMI 15-17.5) OR meet criteria for sub-threshold AN, i.e., all DSM-IV criteria except that patients can have a BMI of <18.5 kg/m2 with or without amenorrhea.
Free T below the median for healthy women of reproductive age
All participants will be required to have a treatment team in place that consists of (at least) a primary care physician and a psychotherapist. Participants will need to have had regular contact with a primary care physician and be in an individual psychotherapy program. Participants will agree to continue with this treatment team and therapy throughout the active course of the study. If participants are taking psychotropic medications, the dose must be stable for 3 months before study entry

Exclusion criteria

Pregnant women or women of child bearing potential who are not using medically accepted means of contraception (to include oral contraceptive, patch or implant, condom, diaphragm, spermicide, intrauterine device, tubal ligation, or partner with vasectomy).
Unstable medical illness, including cardiovascular, hepatic, renal, respiratory, endocrine, neurologic
Serious suicide risk, substance use disorder active within last 6 months, bipolar I disorder, severe current depressive symptoms (indexed by HAM-D score >20 [excluding 2 eating/weight loss items related to the symptoms of AN]), or psychotic disorder
New psychotropic drug regimen, specifically a significant dose change or change in drug class, within the last 6 weeks. A study psychiatrist will assess whether PRN medications and dose changes are clinically significant enough to defer enrollment of specific potential study subjects.
Untreated hypothyroidism
If receiving estrogen therapy, including oral contraceptives or transdermal estrogen therapy, significant change in dose in the prior 3 months
Use of androgens or androgen precursors, including T, DHEA and methyl T, within 3 months
Any investigational psychotropic drug within the last 3 months
In the judgment of the study clinician, unlikely to be able to participate safely throughout the study period
Alanine aminotransferase (ALT) > 2x upper limit of normal
Creatinine >1.5x upper limit
Serum potassium < lower limit of normal
If participating in the sub study, unable to tolerate 1 hour in MRI; contraindication to MRI (such as implanted pacemaker, cerebral aneurysm clips, extensive orthopedic hardware instrumentation); gastrointestinal tract surgery (including gastrectomy, gastric bypass surgery, and small or large bowel resection); history of psychosis by SCID