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

Oxytocin, Lorazepam, Anti-Anxiety Agents, Physiological Effects of Drugs Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03829839
• Other study ID #: LOXY
• Status: Completed
• Phase: Phase 1
• Start date: March 3, 2016
• Est. completion date: August 16, 2017

Study information

• Verified date: April 2019
• Source: University Hospital, Bonn
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: August 16, 2017
• Est. primary completion date: August 16, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 40 Years

Eligibility

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)

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
Germany	Department of Psychiatry, University of Bonn	Bonn

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bonn

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neural responses to emotional faces in the amygdala subregions	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.	Neural activations with be measured with 7 Tesla fMRI in an emotional face matching task that lasts 20 mins

External Links

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