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NCT03846739 Clinical Trial

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

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03846739
Other study ID # PROXY2
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date April 3, 2017
Est. completion date December 31, 2018

Study information
Verified date February 2019
Source University Hospital, Bonn
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 92
Est. completion date December 31, 2018
Est. primary completion date December 31, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 40 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• Oxytocin nasal spray
Intranasal administration, 6, 12, or 24 international units (IU) oxytocin.
• Placebo
The placebo nasal sprays contain identical ingredients except for the peptide itself.

Locations
Country Name City State
Germany Department of Psychiatry, University of Bonn Bonn

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Bonn

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
Primary 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
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