Status:
COMPLETED
The Impact of Oxytocin on the Neurobiology of Anorexia Nervosa
Lead Sponsor:
University of Minnesota
Collaborating Sponsors:
Klarman Foundation
Conditions:
Anorexia Nervosa
Eligibility:
FEMALE
18+ years
Phase:
EARLY_PHASE1
Brief Summary
This study will use a randomized, controlled, double-blind design involving the administration of intranasal oxytocin (INOT) or placebo to adults with anorexia nervosa, restricting subtype and age-mat...
Detailed Description
The primary objective of this investigation is to determine the impact of oxytocin (OT), a peptide hormone that influences social affiliation, on socioemotional neural circuitry and eating disorder be...
Eligibility Criteria
Inclusion
- All participants:
- Age \> 18 years old
- Female (given the potential sex differences to endogenous OT to INOT)
- Ability to read and speak in English
- Right-handed
- Anorexia nervosa participants:
- DSM-5 diagnosis of AN, restricting subtype (established by the SCID-5-RV),
- BMI \< 18.5 kg/m2 within the past month
Exclusion
- All participants
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- Medical instability or current pregnancy or lactation
- Current substance use disorder, psychosis, or bipolar-I disorder
- Contraindication for fMRI (e.g., implanted metal)
- History of neurological disorder/injury (e.g., stroke; head injury with \> 10 minutes loss of consciousness)
- Food allergy that cannot be accommodated through substitutions to the laboratory test meal
- Lacking capacity to consent
- Contraindications for intranasal oxytocin administration
- Acute suicidality
- Psychoactive medication (e.g., antidepressants, antipsychotics)
- Exclusion for participants without anorexia nervosa
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- Current DSM-5 Axis-I diagnosis or current or past eating disorder diagnosis
- BMI \< 19.0
Key Trial Info
Start Date :
September 25 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 30 2021
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT03414112
Start Date
September 25 2018
End Date
April 30 2021
Last Update
February 11 2022
Active Locations (1)
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1
University of Minnesota - Dept of Psychiatry
Minneapolis, Minnesota, United States, 55454