The Impact of Oxytocin on the Neurobiology of Anorexia Nervosa

NCT03414112 | Completed Early Phase 1 DMC FDA Drug

• 1 other identifier: PSYCH-2017-26002
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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-matched controls prior to neuroimaging to assess the impact on frontolimbic brain activity in response to socioemotional stimuli as well as eating behavior in a test meal paradigm.

Conditions

Anorexia Nervosa

Outcome Measures

Primary Outcomes (2)

• Test meal

  Participants will complete a test meal

  Following intranasal oxytocin or placebo (within 1-3 hours)

• fMRI measures

  Neural activation in regions of interest (ROIs) in socioemotional circuitry (i.e., ACC, amygdala, medial PFC, NAcc) in response to INOT or placebo and social threat vs. neutral tasks and social reward vs. neutral stimuli

  Following intranasal oxytocin or placebo administration (within 1-3 hours)

Study Arms (2)

Intranasal Oxytocin Placebo

PLACEBO COMPARATOR

Intranasal placebo

Biological: Intranasal oxytocin

Intranasal Oxytocin

EXPERIMENTAL

Intranasal oxytocin

Biological: Intranasal oxytocin

Interventions

Intranasal oxytocin BIOLOGICAL

oxytocin is a peptide hormone that influences social affiliation

Intranasal Oxytocin; Intranasal Oxytocin Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)
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• Current DSM-5 Axis-I diagnosis or current or past eating disorder diagnosis
• BMI \< 19.0

Sponsors & Collaborators

• University of Minnesota: lead
• Klarman Foundation: collaborator

Study Sites (1)

University of Minnesota - Dept of Psychiatry

Minneapolis, Minnesota, 55454, United States

Location

MeSH Terms

Conditions

Anorexia Nervosa

Condition Hierarchy (Ancestors)

Feeding and Eating Disorders; Mental Disorders

Study Officials

• Carol B Peterson, PhD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

• Ann F Haynos, PhD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The study will be double blind; participants and study staff will not know if the participant is receiving intranasal oxytocin or placebo.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants with anorexia nervosa and age-matched control participants will complete two separate fMRI and test meal assessments: one following administration of intranasal oxytocin and one following placebo. The study will be double blind.

Study Record Dates

• First Submitted: January 22, 2018
• First Posted: January 29, 2018
• Study Start: September 25, 2018
• Primary Completion: April 30, 2021
• Study Completion: April 30, 2021
• Last Updated: February 11, 2022

Record last verified: 2022-02

Locations

US (1)