Hormonal Factors in the Treatment of Anorexia Nervosa

NCT01121211 | Completed Phase 2 Results DMC

• 2 other identifiers: 2009P-001845/15R01MH083657-05A2
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Anorexia Nervosa; Eating Disorder; Anxiety; Depression

Keywords

Testosterone; Hormones; Mental Health

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Testosterone

ACTIVE COMPARATOR

Testosterone x 24 weeks

Drug: Testosterone

Placebo

PLACEBO COMPARATOR

Placebo x 24 weeks

Drug: Placebo

Interventions

Testosterone DRUG

Testosterone 300mcg transdermal patch x 24 weeks.

Testosterone

Placebo DRUG

Placebo transdermal patch x 24 weeks

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02144, United States

Location

Related Publications (2)

• Plessow F, Galbiati F, Eddy KT, Misra M, Miller KK, Klibanski A, Aulinas A, Lawson EA. Low oxytocin levels are broadly associated with more pronounced psychopathology in anorexia nervosa with primarily restricting but not binge/purge eating behavior. Front Endocrinol (Lausanne). 2023 Jan 31;13:1049541. doi: 10.3389/fendo.2022.1049541. eCollection 2022.

  PMID: 36798485 DERIVED

• 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.

  PMID: 31219558 DERIVED

MeSH Terms

Conditions

Anorexia Nervosa; Feeding and Eating Disorders; Anxiety Disorders; Depression; Psychological Well-Being

Interventions

Testosterone

Condition Hierarchy (Ancestors)

Mental Disorders; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior; Personal Satisfaction

Intervention Hierarchy (Ancestors)

Androstenols; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Testosterone Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Results Point of Contact

• Title: Dr. Anne Klibanski
• Organization: Massachusetts General Hospital

aklibanski@partners.org

6177263870

Study Officials

• Anne Klibanski, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

• Karen K Miller, MD

  Massachusetts General Hospital

  STUDY DIRECTOR

• Erinne Meenaghan, NP

  Massachusetts General Hospital

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Neuroendocrine Unit

Study Record Dates

• First Submitted: May 10, 2010
• First Posted: May 12, 2010
• Study Start: April 1, 2010
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: September 2, 2020
• Results First Posted: April 26, 2017

Record last verified: 2020-08

Locations

US (1)