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

NCT03829839 | Completed Phase 1

• 1 other identifier: LOXY
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Oxytocin or PLC

ACTIVE COMPARATOR

Single dose of intranasal oxytocin (24 international units) or PLC.

Drug: Oxytocin; Drug: Placebo nasalspray

Lorazepam or PLC

ACTIVE COMPARATOR

Single dose of lorazepam (1mg) or PLC

Drug: Lorazepam 1 mg; Drug: Placebo Oral Tablet

Interventions

Oxytocin DRUG

Intranasal administration, 24 international units (IU) oxytocin

Also known as: syntocinon

Oxytocin or PLC

Lorazepam 1 mg DRUG

Oral administration of 1mg lorazepam

Also known as: Tavor

Lorazepam or PLC

Placebo nasalspray DRUG

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

Oxytocin or PLC

Placebo Oral Tablet DRUG

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

Lorazepam or PLC

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• healthy male volunteers
• right-handed

You may not qualify if:

• Current or past psychiatric illness
• Current or past physical illness
• Psychoactive medication
• Sedative medication
• MRI contraindication (e.g. metal in body, claustrophobia)

Sponsors & Collaborators

• University Hospital, Bonn: lead

Study Sites (1)

Department of Psychiatry, University of Bonn

Bonn, 53105, Germany

Location

Related Links

• Related Info

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Oxytocin; Lorazepam; oxybutynin

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Benzodiazepinones; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice Chair of the Department of Psychiatry and Chair of the Medical Psychology Division

Study Record Dates

• First Submitted: February 1, 2019
• First Posted: February 4, 2019
• Study Start: March 3, 2016
• Primary Completion: August 16, 2017
• Study Completion: August 16, 2017
• Last Updated: April 17, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)