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

NCT03846739 | Completed Phase 1

• 1 other identifier: PROXY2
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

amygdala; reward; oxytocin; dose; emotion processing; sex differences

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (3)

Oxytocin & Placebo, 6 IU

ACTIVE COMPARATOR

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

Drug: Oxytocin nasal spray; Drug: Placebo

Oxytocin & Placebo, 12 IU

ACTIVE COMPARATOR

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

Drug: Oxytocin nasal spray; Drug: Placebo

Oxytocin & Placebo, 24 IU

ACTIVE COMPARATOR

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

Drug: Oxytocin nasal spray; Drug: Placebo

Interventions

Oxytocin nasal spray DRUG

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

Oxytocin & Placebo, 12 IU; Oxytocin & Placebo, 24 IU; Oxytocin & Placebo, 6 IU

Placebo DRUG

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

Oxytocin & Placebo, 12 IU; Oxytocin & Placebo, 24 IU; Oxytocin & Placebo, 6 IU

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Bonn: lead

Study Sites (1)

Department of Psychiatry, University of Bonn

Bonn, 53105, Germany

Location

Related Links

• Neuromodulation of Emotion (NEMO) research group

Study Officials

• Rene Hurlemann, MD, PhD

  University of Bonn

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair of the Medical Psychology Division and Deputy Chair of the Department of Psychiatry

Study Record Dates

• First Submitted: February 15, 2019
• First Posted: February 20, 2019
• Study Start: April 3, 2017
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2018
• Last Updated: February 28, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)