Hormonal Factors in the Treatment of Anorexia Nervosa

Study Overview
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Brief Summary
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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.

Official Title
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Hormonal Factors in the Treatment of Anorexia Nervosa

Conditions
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Depression, Anorexia Nervosa, Eating Disorder, Anxiety

Intervention / Treatment
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* Drug: Testosterone
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Testosterone<br>Testosterone x 24 weeks | Drug: Testosterone<br>* Testosterone 300mcg transdermal patch x 24 weeks.<br>|
| Placebo Comparator: Placebo<br>Placebo x 24 weeks | Drug: Placebo<br>* Placebo transdermal patch x 24 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Weight | Weight in kilograms | Baseline, 24 Weeks | 
| Change From Baseline in Depression Symptom Severity | Hamilton Depression Rating Scale (HAM-D) (Higher score = greater depression symptom severity; Score Range 0 - ≥ 23) | Baseline, 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Testosterone, Hormones, Mental Health