Skip to main content
OpenTrials
Completed

NCT Number: NCT03829839

Effects of Oxytocin and Lorazepam on Fear-related Intra-amygdalar Activity

High-potency benzodiazepines have strong anxiolytic effects accompanied by significant adverse effects including impaired cognitive function, drowsiness, dizziness and impaired motoric abilities. Importantly, the long-term use of benzodiazepines may produce dependence and withdrawal. Therefore, there is considerable scientific and public interest in identifying new anxiolytic agents.

The hypothalamic peptide oxytocin (OXT) has anxiolytic effects both in healthy participants and patients with anxiety disorders by decreasing fear-associated amygdala activity. However, so far no human study has directly compared the underlying anxiolytic mechanisms of OXT and established anxiolytic agents on amygdala activity. Importantly, the amygdala is not a homogenous structure but rather consists of several subdivisions with structural and functional differences.

Therefore, the rationale of the present project is to determine the effects of intranasal OXT and the high-potency benzodiazepine lorazepam on fear-associated responses in intra-amygdalar subregions.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Oxytocin, Lorazepam, Anti-Anxiety Agents, Physiological Effects of Drugs Anxiety Disorders Mental Disorders

Age range

18 year–40 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Department of Psychiatry, University of Bonn

Bonn, 53105, Germany

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • healthy male volunteers
  • right-handed

Exclusion criteria

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

Treatment and study plan

Oxytocin

Drug

Intranasal administration, 24 international units (IU) oxytocin

Other names: syntocinon

Lorazepam 1 mg

Drug

Oral administration of 1mg lorazepam

Other names: Tavor

Placebo Nasalspray

Drug

The placebo nasalspray contain identical ingredients except for the active agent itself.

Placebo oral tablet

Drug

The placebo pill contain identical ingredients except for the active agent itself.

Primary outcomes

  1. Neural responses to emotional faces in the amygdala subregions

    Time frame: Neural activations with be measured with 7 Tesla fMRI in an emotional face matching task that lasts 20 mins

    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 subregion responses to emotional faces.

Sponsors and collaborators

Lead sponsor

University Hospital, Bonn

Other

Registry information

Official study title

Common and Dissociable Effects of Oxytocin and Lorazepam on the Neurocircuitry of Fear - an Ultra-high Field Imaging Study

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Feb 4, 2019
Registry last updated
Apr 17, 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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.