Anorexia NervosaPhase 2NCT01121211
Hormonal Factors in the Treatment of Anorexia Nervosa
A Phase 2 study testing Testosterone in people with Anorexia Nervosa and Eating Disorder, run by Massachusetts General Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Anorexia Nervosa, Eating Disorder, Anxiety
- What is being tested?
- Testosterone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2010to Feb 2016
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02144
About this study
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
- Being tested
- Testosterone, Placebo
- Keywords
- Testosterone, Hormones, Mental Health
- Medical subject headings
- Anorexia Nervosa, Feeding and Eating Disorders, Anxiety Disorders, Depression, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TestosteroneDrug
Testosterone 300mcg transdermal patch x 24 weeks.
PlaceboDrug
Placebo transdermal patch x 24 weeks
| Study group | Role | What they receive |
|---|---|---|
| Testosterone | Active comparator | Testosterone x 24 weeks Receives: Drug: Testosterone |
| Placebo | Placebo comparator | Placebo x 24 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Weight
Weight in kilograms
Measured: 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)
Measured: Baseline, 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2010 (estimated)
- Study startApr 2010
- Primary completionFeb 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Anorexia NervosaStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Karen Klahr Miller, MD, Massachusetts General Hospital
- Investigators
- Anne Klibanski, MD, Principal investigator, Massachusetts General HospitalKaren K Miller, MD, Study director, Massachusetts General HospitalErinne Meenaghan, NP, Study chair, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01121211
- Sponsor's protocol ID
- 2009P-001845/1
- Other IDs
- 5R01MH083657-05A2
- Status last verified
- Aug 2020
- First submitted
- 10 May 2010
- Last updated
- 2 Sep 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 36798485Kimball 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.
PubMed 31219558
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hormonal Factors in the Treatment of Anorexia Nervosa
- ClinicalTrials.gov ID
- NCT01121211
- Acronym / sponsor ID
- 2009P-001845/1
- Conditions
- Anorexia Nervosa, Eating Disorder, Anxiety, Depression
- Keywords
- Testosterone, Hormones, Mental Health
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Apr 2010
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 12 May 2010 (estimated)
- Results
- Posted 26 Apr 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Testosterone | Active comparator | Drug: TestosteroneTestosterone x 24 weeks |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo x 24 weeks |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TestosteroneTestosterone 300mcg transdermal patch x 24 weeks. | Drug | Testosterone |
| PlaceboPlacebo transdermal patch x 24 weeks | Drug | Placebo |
Primary outcome
Change From Baseline in Weight
Time frame: Baseline, 24 Weeks
Weight in kilograms
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)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36798485Plessow 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.
- Derived from this study: PubMed 31219558Kimball 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne Klibanski, MD principal investigator
Massachusetts General Hospital
Karen K Miller, MD study director
Massachusetts General Hospital
Erinne Meenaghan, NP study chair
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Testosterone in people with Anorexia Nervosa and Eating Disorder, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Apr 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Weight (time frame: Baseline, 24 Weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01121211, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2020.