Hormonal Factors in the Treatment of Anorexia Nervosa

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Massachusetts General Hospital
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Anne Klibanski, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01121211
First received: May 10, 2010
Last updated: March 17, 2014
Last verified: March 2014
  Purpose

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 Intervention Phase
Anorexia Nervosa
Eating Disorder
Anxiety
Depression
Drug: Testosterone
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Hormonal Factors in the Treatment of Anorexia Nervosa

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Body Mass Index [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Anxiety and Depression symptoms [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 90
Study Start Date: April 2010
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Testosterone
Testosterone x 24 weeks
Drug: Testosterone
Testosterone 300mcg transdermal patch x 24 weeks.
Drug: Placebo
Placebo transdermal patch x 24 weeks
Placebo Comparator: Placebo
Placebo x 24 weeks
Drug: Testosterone
Testosterone 300mcg transdermal patch x 24 weeks.
Drug: Placebo
Placebo transdermal patch x 24 weeks

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01121211

Contacts
Contact: Erinne Meenaghan, NP 617-724-7393 emeenaghan@partners.org
Contact: Karen Miller, MD 617- 726-3870 KKMiller@partners.org

Locations
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02144
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
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
  More Information

No publications provided

Responsible Party: Anne Klibanski, MD, Chief, Neuroendocrine Unit, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01121211     History of Changes
Other Study ID Numbers: 2009P-001845/1, 1R01MH083657-01A2
Study First Received: May 10, 2010
Last Updated: March 17, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Massachusetts General Hospital:
Testosterone
Hormones
Mental Health

Additional relevant MeSH terms:
Anorexia
Anorexia Nervosa
Anxiety Disorders
Depression
Depressive Disorder
Eating Disorders
Signs and Symptoms, Digestive
Signs and Symptoms
Mental Disorders
Behavioral Symptoms
Mood Disorders
Testosterone
Testosterone enanthate
Testosterone undecanoate
Testosterone 17 beta-cypionate
Methyltestosterone
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Anabolic Agents

ClinicalTrials.gov processed this record on August 28, 2014