Dose-dependent Effects of Oxytocin on the Amygdala and Reward System

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Oxytocin nasal spray; Drug: Placebo

• Registration Number: NCT03846739
• Lead Sponsor: University Hospital, Bonn

Brief Summary

The purpose of this study is to determine whether effects of intranasal oxytocin on amygdala and reward system responses vary as a function of treatment dose in women in comparison to men.

Detailed Description

The objective of the present study is to determine whether intranasal oxytocin (IN-OXT) effects on blood oxygenation level-dependent functional magnetic resonance imaging (BOLD fMRI) in the amygdala and striatal regions (putamen, nucleus accumbens, caudate, pallidum) vary as a function of dose. In particular, the investigators plan to compare effects of three different IN-OXT doses (6, 12, and 24 international units, IU) on established neural and behavioural correlates of emotion processing in women. Results will be discussed in comparison to a previous study of OXT kinetics in men.

Study Timeline

• Study Start: 2017-04-03
• Primary Completion: 2018-12-31
• Study Completion: 2018-12-31
• Status Verified: 2019-02
• Study First Submitted: 2019-02-15
• Study First Submitted QC: 2019-02-15
• Study First Posted: 2019-02-20
• Last Update Submitted: 2019-02-27
• Last Update Posted: 2019-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 92

Inclusion Criteria

• Healthy female volunteers
• Right-handed
• Non-smoker

Exclusion Criteria

• Current psychiatric or physical illness
• Hormonal contraception
• Psychoactive medication
• MRI contraindication (e.g. metal in body, claustrophobia)
• Pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Oxytocin & Placebo, 6 IU	Oxytocin nasal spray	Intranasal administration, 6 IU oxytocin nasal spray or placebo. Imaging starting 45 min after nasal spray administration.
Oxytocin & Placebo, 6 IU	Placebo	Intranasal administration, 6 IU oxytocin nasal spray or placebo. Imaging starting 45 min after nasal spray administration.
Oxytocin & Placebo, 24 IU	Placebo	Intranasal administration, 24 IU oxytocin nasal spray or placebo. Imaging starting 45 min after nasal spray administration.
Oxytocin & Placebo, 12 IU	Oxytocin nasal spray	Intranasal administration,12 IU oxytocin nasal spray or placebo. Imaging starting 45 min after nasal spray administration.
Oxytocin & Placebo, 12 IU	Placebo	Intranasal administration,12 IU oxytocin nasal spray or placebo. Imaging starting 45 min after nasal spray administration.
Oxytocin & Placebo, 24 IU	Oxytocin nasal spray	Intranasal administration, 24 IU oxytocin nasal spray or placebo. Imaging starting 45 min after nasal spray administration.

Primary Outcome Measures

Name	Time	Method
Neural substrates of emotion processing, measured via blood-oxygen-level dependent signal in the amygdala	45 min after nasal spray administration	Functional magnetic resonance imaging (fMRI) will be performed to measure blood-oxygen-level dependent signal in response to emotional face stimuli. The investigators specifically plan to investigate amygdala responses to emotional faces, because previous studies found sex-specific effects of oxytocin on amygdala activation.
Neural substrates of emotion processing, measured via blood-oxygen-level dependent signal in striatal regions (putamen, nucleus accumbens, caudate, pallidum)	45 min after nasal spray administration	Functional magnetic resonance imaging (fMRI) will be performed to measure blood-oxygen-level dependent signal in response to emotional face stimuli. The investigators specifically plan to investigate striatal responses to emotional faces to explore sex-specific effects of OXT on reward-related brain activation.

Trial Locations

Locations (1)

Department of Psychiatry, University of Bonn; 🇩🇪 Bonn, Germany