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

Dose-dependent Effects of Oxytocin on the Amygdala and Reward System Vary Between Women and Men

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Oxytocin nasal spray; Drug: Placebo

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 Type: Interventional
• Enrollment (Actual): 92
• Phase: Phase 1

Contacts and Locations

Study Locations

• Germany
  • Bonn, Germany, 53105
    • Department of Psychiatry, University of Bonn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Oxytocin & Placebo, 6 IU; Intranasal administration, 6 IU oxytocin nasal spray or placebo. Imaging starting 45 min after nasal spray administration.	Drug: Oxytocin nasal spray; Intranasal administration, 6, 12, or 24 international units (IU) oxytocin.; Drug: Placebo; The placebo nasal sprays contain identical ingredients except for the peptide itself.
Active Comparator: Oxytocin & Placebo, 12 IU; Intranasal administration,12 IU oxytocin nasal spray or placebo. Imaging starting 45 min after nasal spray administration.	Drug: Oxytocin nasal spray; Intranasal administration, 6, 12, or 24 international units (IU) oxytocin.; Drug: Placebo; The placebo nasal sprays contain identical ingredients except for the peptide itself.
Active Comparator: Oxytocin & Placebo, 24 IU; Intranasal administration, 24 IU oxytocin nasal spray or placebo. Imaging starting 45 min after nasal spray administration.	Drug: Oxytocin nasal spray; Intranasal administration, 6, 12, or 24 international units (IU) oxytocin.; Drug: Placebo; The placebo nasal sprays contain identical ingredients except for the peptide itself.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neural substrates of emotion processing, measured via blood-oxygen-level dependent signal in the amygdala	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.	45 min after nasal spray administration
Neural substrates of emotion processing, measured via blood-oxygen-level dependent signal in striatal regions (putamen, nucleus accumbens, caudate, pallidum)	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.	45 min after nasal spray administration

Collaborators and Investigators

• Sponsor: University Hospital, Bonn
• Investigators: Principal Investigator: René Hurlemann, MD, PhD, University of Bonn

Publications and helpful links

Helpful Links

• Neuromodulation of Emotion (NEMO) research group

Study record dates

Study Major Dates

• Study Start (Actual): April 3, 2017
• Primary Completion (Actual): December 31, 2018
• Study Completion (Actual): December 31, 2018

Study Registration Dates

• First Submitted: February 15, 2019
• First Submitted That Met QC Criteria: February 15, 2019
• First Posted (Actual): February 20, 2019

Study Record Updates

• Last Update Posted (Actual): February 28, 2019
• Last Update Submitted That Met QC Criteria: February 27, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: sex differences; oxytocin; amygdala; reward; dose; emotion processing
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Reproductive Control Agents; Oxytocics; Oxytocin
• Other Study ID Numbers: PROXY2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No