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

NCT ID: NCT03846739

Last Updated: 2019-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

92 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-03

Study Completion Date

2018-12-31

Brief Summary

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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

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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.

Conditions

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Healthy

Keywords

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amygdala reward oxytocin dose emotion processing sex differences

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Oxytocin & Placebo, 6 IU

Intranasal administration, 6 IU oxytocin nasal spray or placebo. Imaging starting 45 min after nasal spray administration.

Group Type ACTIVE_COMPARATOR

Oxytocin nasal spray

Intervention Type DRUG

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

Placebo

Intervention Type DRUG

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

Oxytocin & Placebo, 12 IU

Intranasal administration,12 IU oxytocin nasal spray or placebo. Imaging starting 45 min after nasal spray administration.

Group Type ACTIVE_COMPARATOR

Oxytocin nasal spray

Intervention Type DRUG

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

Placebo

Intervention Type DRUG

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

Oxytocin & Placebo, 24 IU

Intranasal administration, 24 IU oxytocin nasal spray or placebo. Imaging starting 45 min after nasal spray administration.

Group Type ACTIVE_COMPARATOR

Oxytocin nasal spray

Intervention Type DRUG

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

Placebo

Intervention Type DRUG

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

Interventions

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Oxytocin nasal spray

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

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital, Bonn

OTHER

Sponsor Role lead

Responsible Party

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Rene Hurlemann

Chair of the Medical Psychology Division and Deputy Chair of the Department of Psychiatry

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rene Hurlemann, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Bonn

Locations

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Department of Psychiatry, University of Bonn

Bonn, , Germany

Site Status

Countries

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Germany

Related Links

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http://renehurlemann.squarespace.com/welcome/

Neuromodulation of Emotion (NEMO) research group

Other Identifiers

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PROXY2

Identifier Type: -

Identifier Source: org_study_id