Phase 2
N=90
Hormonal Factors in the Treatment of Anorexia Nervosa
Anorexia Nervosa · Eating Disorder · Anxiety · Depression
Bottom Line
View on ClinicalTrials.gov: NCT01121211 ↗Enrolled (actual)
90
Serious AEs
5.6%
Results posted
Apr 2017
Primary outcome: Primary: Change From Baseline in Weight — 0.1; 1.5 kilograms
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Testosterone (Drug); Placebo (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Massachusetts General Hospital
- Primary completion
- Feb 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Weight |
0.1; 1.5 | — |
| PRIMARY Change From Baseline in Depression Symptom Severity |
-3; -3 | — |
Summary
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.
Eligibility Criteria
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 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
Data sourced from ClinicalTrials.gov (NCT01121211). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.