Hormonal Factors in the Treatment of Anorexia Nervosa

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01121211
Recruitment Status : Completed
First Posted : May 12, 2010
Results First Posted : April 26, 2017
Last Update Posted : August 10, 2017
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Anne Klibanski, MD, Massachusetts General Hospital

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.

Condition or disease Intervention/treatment Phase
Anorexia Nervosa Eating Disorder Anxiety Depression Drug: Testosterone Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Hormonal Factors in the Treatment of Anorexia Nervosa
Study Start Date : April 2010
Actual Primary Completion Date : February 2016
Actual Study Completion Date : February 2016

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Testosterone
Testosterone x 24 weeks
Drug: Testosterone
Testosterone 300mcg transdermal patch x 24 weeks.

Placebo Comparator: Placebo
Placebo x 24 weeks
Drug: Placebo
Placebo transdermal patch x 24 weeks

Primary Outcome Measures :
  1. Change From Baseline in Weight [ Time Frame: Baseline, 24 Weeks ]
    Weight in kilograms

  2. Change From Baseline in Depression Symptom Severity [ Time Frame: Baseline, 24 weeks ]
    Hamilton Depression Rating Scale (HAM-D) (Higher score = greater depression symptom severity; Score Range 0 - ≥ 23)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01121211

United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02144
Sponsors and Collaborators
Massachusetts General Hospital
National Institute of Mental Health (NIMH)
Principal Investigator: Anne Klibanski, MD Massachusetts General Hospital
Study Director: Karen K Miller, MD Massachusetts General Hospital
Study Chair: Erinne Meenaghan, NP Massachusetts General Hospital

Responsible Party: Anne Klibanski, MD, Chief, Neuroendocrine Unit, Massachusetts General Hospital Identifier: NCT01121211     History of Changes
Other Study ID Numbers: 2009P-001845/1
5R01MH083657-05A2 ( U.S. NIH Grant/Contract )
First Posted: May 12, 2010    Key Record Dates
Results First Posted: April 26, 2017
Last Update Posted: August 10, 2017
Last Verified: July 2017

Keywords provided by Anne Klibanski, MD, Massachusetts General Hospital:
Mental Health

Additional relevant MeSH terms:
Feeding and Eating Disorders
Anorexia Nervosa
Mental Disorders
Signs and Symptoms, Digestive
Signs and Symptoms
Testosterone enanthate
Testosterone undecanoate
Testosterone 17 beta-cypionate
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anabolic Agents