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

Phase 1

Completed

• Conditions: Oxytocin, Lorazepam, Anti-Anxiety Agents, Physiological Effects of Drugs
• Interventions: Drug: Lorazepam 1 mg; Drug: Oxytocin; Drug: Placebo nasalspray; Drug: Placebo Oral Tablet

• Registration Number: NCT03829839
• Lead Sponsor: University Hospital, Bonn

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-03-03
• Primary Completion: 2017-08-16
• Study Completion: 2017-08-16
• Study First Submitted: 2019-02-01
• Study First Submitted QC: 2019-02-01
• Study First Posted: 2019-02-04
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-15
• Last Update Posted: 2019-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 120

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oxytocin or PLC	Placebo nasalspray	Single dose of intranasal oxytocin (24 international units) or PLC.
Lorazepam or PLC	Lorazepam 1 mg	Single dose of lorazepam (1mg) or PLC
Lorazepam or PLC	Placebo Oral Tablet	Single dose of lorazepam (1mg) or PLC
Oxytocin or PLC	Oxytocin	Single dose of intranasal oxytocin (24 international units) or PLC.

Primary Outcome Measures

Name	Time	Method
Neural responses to emotional faces in the amygdala subregions	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.

Trial Locations

Locations (1)

Department of Psychiatry, University of Bonn; 🇩🇪 Bonn, Germany