NCT03829839

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: University Hospital, Bonn · Academic / Other
• Sex: Male
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Oxytocin, Lorazepam, Anti-Anxiety Agents, Physiological Effects of Drugs

Interventions

Type	Name	Description
DRUG	Oxytocin	Intranasal administration, 24 international units (IU) oxytocin
DRUG	Lorazepam 1 mg	Oral administration of 1mg lorazepam
DRUG	Placebo nasalspray	The placebo nasalspray contain identical ingredients except for the active agent itself.
DRUG	Placebo Oral Tablet	The placebo pill contain identical ingredients except for the active agent itself.

Timeline

• Start date: 2016-03-03
• Primary completion: 2017-08-16
• Completion: 2017-08-16
• First posted: 2019-02-04
• Last updated: 2019-04-17

Locations

1 site across 1 country: Germany