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

April 15, 2019 updated by: Rene Hurlemann, University Hospital, Bonn

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Bonn, Germany, 53105
        • Department of Psychiatry, University of Bonn

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Oxytocin or PLC
Single dose of intranasal oxytocin (24 international units) or PLC.
Drug: Oxytocin
Intranasal administration, 24 international units (IU) oxytocin
Other Names:
  • syntocinon
Drug: Placebo nasalspray
The placebo nasalspray contain identical ingredients except for the active agent itself.
Active Comparator: Lorazepam or PLC
Single dose of lorazepam (1mg) or PLC
Drug: Lorazepam 1 mg
Oral administration of 1mg lorazepam
Other Names:
  • Tavor
Drug: Placebo Oral Tablet
The placebo pill contain identical ingredients except for the active agent itself.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neural responses to emotional faces in the amygdala subregions
Time Frame: 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.
Neural activations with be measured with 7 Tesla fMRI in an emotional face matching task that lasts 20 mins

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Bonn

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 3, 2016

Primary Completion (Actual)

August 16, 2017

Study Completion (Actual)

August 16, 2017

Study Registration Dates

First Submitted

February 1, 2019

First Submitted That Met QC Criteria

February 1, 2019

First Posted (Actual)

February 4, 2019

Study Record Updates

Last Update Posted (Actual)

April 17, 2019

Last Update Submitted That Met QC Criteria

April 15, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LOXY

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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