Clinical trial NCT01121211: Hormonal Factors in the Treatment of Anorexia Nervosa
Official title: Hormonal Factors in the Treatment of Anorexia Nervosa
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Anorexia Nervosa
Eating Disorder
Anxiety
Depression
Keywords: Testosterone
Hormones
Mental Health
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2010-05-12
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 \<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

Primary outcomes:
measure: Change From Baseline in Weight
timeFrame: Baseline, 24 Weeks
measure: Change From Baseline in Depression Symptom Severity
timeFrame: Baseline, 24 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Anne Klibanski, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Massachusetts General Hospital
name: Karen K Miller, MD
role: STUDY_DIRECTOR
affiliation: Massachusetts General Hospital
name: Erinne Meenaghan, NP
role: STUDY_CHAIR
References:
citation: Kimball A, Schorr M, Meenaghan E, Bachmann KN, Eddy KT, Misra M, Lawson EA, Kreiger-Benson E, Herzog DB, Koman S, Keane RJ, Ebrahimi S, Schoenfeld D, Klibanski A, Miller KK. A Randomized Placebo-Controlled Trial of Low-Dose Testosterone Therapy in Women With Anorexia Nervosa. J Clin Endocrinol Metab. 2019 Oct 1;104(10):4347-4355. doi: 10.1210/jc.2019-00828.