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

University Hospital Bonn (UKB)

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Oxytocin nasal spray; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT03846739

PROXY2

Details and patient eligibility

About

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.

Full 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.

Enrollment: 92 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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92 participants in 3 patient groups

Oxytocin & Placebo, 6 IU

Active Comparator group

Description:

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

Treatment:

Drug: Oxytocin nasal spray

Drug: Placebo

Oxytocin & Placebo, 12 IU

Active Comparator group

Description:

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

Treatment:

Drug: Oxytocin nasal spray

Drug: Placebo

Oxytocin & Placebo, 24 IU

Active Comparator group

Description:

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

Treatment:

Drug: Oxytocin nasal spray

Drug: Placebo