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

NCT03829839 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2019-04-17

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • University Hospital, Bonn

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-03-03
Primary Completion
2017-08-16
Completion
2017-08-16

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03829839 on ClinicalTrials.gov