The Impact of Oxytocin on the Neurobiology of Anorexia Nervosa

• Sponsor: University of Minnesota (Other)
• Overall Status: Completed
• CT.gov ID: NCT03414112
• Collaborator: Klarman Foundation (Other)
• Enrollment: 16
• Location: 1
• Arms: 2
• Actual Duration (Months): 31.1
• Patients Per Site Per Month: 0.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Anorexia Nervosa	Biological: Intranasal oxytocin	Early Phase 1

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 16 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: 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.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.
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Masking Description: The study will be double blind; participants and study staff will not know if the participant is receiving intranasal oxytocin or placebo.
• Primary Purpose: Other
• Official Title: Investigating the Impact of Oxytocin on the Neurobiological Underpinnings of Socioemotional Deficits in Anorexia Nervosa
• Actual Study Start Date: Sep 25, 2018
• Actual Primary Completion Date: Apr 30, 2021
• Actual Study Completion Date: Apr 30, 2021

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Intranasal Oxytocin Placebo Intranasal placebo	Biological: Intranasal oxytocin; oxytocin is a peptide hormone that influences social affiliation
Experimental: Intranasal Oxytocin Intranasal oxytocin	Biological: Intranasal oxytocin; oxytocin is a peptide hormone that influences social affiliation

Outcome Measures

Primary Outcome Measures

1. Test meal [Following intranasal oxytocin or placebo (within 1-3 hours)]

   Participants will complete a test meal

2. fMRI measures [Following intranasal oxytocin or placebo administration (within 1-3 hours)]

   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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: 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:

All participants

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

1. Current DSM-5 Axis-I diagnosis or current or past eating disorder diagnosis

2. BMI < 19.0

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Minnesota - Dept of Psychiatry	Minneapolis	Minnesota	United States	55454

Sponsors and Collaborators

• University of Minnesota
• Klarman Foundation

Investigators

• Principal Investigator: Carol B Peterson, PhD, University of Minnesota
• Principal Investigator: Ann F Haynos, PhD, University of Minnesota

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Minnesota
• ClinicalTrials.gov Identifier: NCT03414112
• Other Study ID Numbers: PSYCH-2017-26002
• First Posted: Jan 29, 2018
• Last Update Posted: Feb 11, 2022
• Last Verified: Feb 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Anorexia; Anorexia Nervosa; Oxytocin

Study Results

No Results Posted as of Feb 11, 2022