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Completed

NCT Number: NCT03846739

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

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.

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Key information

Conditions

Healthy

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Department of Psychiatry, University of Bonn

Bonn, 53105, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oxytocin nasal spray

Drug

Intranasal administration, 6, 12, or 24 international units (IU) oxytocin.

Placebo

Drug

The placebo nasal sprays contain identical ingredients except for the peptide itself.

Primary outcomes

  1. Neural substrates of emotion processing, measured via blood-oxygen-level dependent signal in the amygdala

    Time frame: 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.

  2. Neural substrates of emotion processing, measured via blood-oxygen-level dependent signal in striatal regions (putamen, nucleus accumbens, caudate, pallidum)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University Hospital, Bonn

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Feb 20, 2019
Registry last updated
Feb 28, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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