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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
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03829839
Enrollment
120
Registered
2019-02-04
Start date
2016-03-03
Completion date
2017-08-16
Last updated
2019-04-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Amygdala, anxiety, benzodiazepines, fear, fMRI, lorazepam, oxytocin, 7 Tesla

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.

Interventions

DRUGOxytocin

Intranasal administration, 24 international units (IU) oxytocin

Oral administration of 1mg lorazepam

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

DRUGPlacebo Oral Tablet

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

Sponsors

University Hospital, Bonn
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
MALE
Age
18 Years to 40 Years
Healthy volunteers
Yes

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)

Design outcomes

Primary

MeasureTime frameDescription
Neural responses to emotional faces in the amygdala subregionsNeural activations with be measured with 7 Tesla fMRI in an emotional face matching task that lasts 20 minsFunctional 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.

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026