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CompletedNCT03414112Updated Feb 11, 2022

The Impact of Oxytocin on the Neurobiology of Anorexia Nervosa

An Early Phase 1 interventional study of Intranasal oxytocin in Anorexia Nervosa, sponsored by University of Minnesota. Completed at 1 site in United States. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-02-11.

Sponsored by University of Minnesota · Early Phase 1, Interventional, and Other

Phase
Early Phase 1
Study type
Interventional
Enrollment
16
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study 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.

Read the 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 behavior in anorexia nervosa (AN). Because socioemotional processing deficits appear to play a key role in AN, OT is implicated as a potential biological mechanism by which eating disorder behavior (e.g., restrictive eating) is maintained. Used as a probe, intranasal oxytocin (INOT) provides an innovative method for examining the short-term impact of OT on socioemotional neural processing disturbances and eating disorder behavior in AN. The proposed study tests a theoretical model of the role of OT in the maintenance of AN by using an INOT probe to determine, and potentially alter, neurobiological responses to socioemotional stimuli. Specifically, this study will use a randomized, controlled, double-blind design involving the administration of INOT or placebo to adults with AN restricting subtype and age-matched controls prior to neuroimaging to assess the impact on frontolimbic brain activity in response to socioemotional stimuli. The potential impact of INOT on restrictive eating will also be assessed in a subsequent test meal. We predict that for participants with AN, INOT, but not placebo, will normalize frontolimbic activation in response to social reward stimuli and prefrontal activation in response to social threat stimuli. In addition, the investigators predict that AN participants will display reduced restrictive eating in a test meal paradigm following INOT (but not placebo) administration. Finally, investigators predict that changes in restrictive eating following INOT administration will be mediated by altered frontolimbic responding to socioemotional cues. This investigation will provide an essential link uniting the data supporting the importance of socioemotional processing deficits in AN with the emerging role of INOT in altering the neural circuits involved in social behavior to test an innovative neurobiological maintenance model of AN.

02

Conditions studied

  • Anorexia Nervosa
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • All participants:

    1. Age > 18 years old
    2. Female (given the potential sex differences to endogenous OT to INOT)
    3. Ability to read and speak in English
    4. Right-handed
  • Anorexia nervosa participants:

    1. DSM-5 diagnosis of AN, restricting subtype (established by the SCID-5-RV),
    2. BMI \< 18.5 kg/m2 within the past month

Exclusion criteria

Exclusion Criteria:

All participants

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  1. Medical instability or current pregnancy or lactation
  2. Current substance use disorder, psychosis, or bipolar-I disorder
  3. Contraindication for fMRI (e.g., implanted metal)
  4. History of neurological disorder/injury (e.g., stroke; head injury with > 10 minutes loss of consciousness)
  5. Food allergy that cannot be accommodated through substitutions to the laboratory test meal
  6. Lacking capacity to consent
  7. Contraindications for intranasal oxytocin administration
  8. Acute suicidality
  9. Psychoactive medication (e.g., antidepressants, antipsychotics)

    Exclusion for participants without anorexia nervosa

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  1. Current DSM-5 Axis-I diagnosis or current or past eating disorder diagnosis
  2. BMI \< 19.0
04

Study design

Phase
Early Phase 1
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
16 participants (actual)

Study arms

  • Placebo comparator
    Intranasal Oxytocin Placebo

    Intranasal placebo

    Biological: Intranasal oxytocin

  • Experimental
    Intranasal Oxytocin

    Intranasal oxytocin

    Biological: Intranasal oxytocin

Interventions

  • BiologicalIntranasal oxytocin

    oxytocin is a peptide hormone that influences social affiliation

05

What researchers measure

Primary outcomes

  1. Test meal

    Participants will complete a test meal

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

  2. 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

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

06

Study locations

1 site
  • University of Minnesota - Dept of Psychiatry
    Minneapolis, Minnesota 55454, United States
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03414112
Lead sponsor
University of Minnesota
Collaborators
Klarman Foundation
Responsible party
Sponsor
First posted
Jan 29, 2018
Start date
Sep 25, 2018
Primary completion
Apr 30, 2021
Completion
Apr 30, 2021
Last update
Feb 11, 2022

Study contacts

Carol B Peterson, PhD
principal investigator · University of Minnesota
Ann F Haynos, PhD
principal investigator · University of Minnesota

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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