- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03829839
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
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
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
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-
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Bonn, Germany, 53105
- Department of Psychiatry, University of Bonn
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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.
|
Intranasal administration, 24 international units (IU) oxytocin
Other Names:
The placebo nasalspray contain identical ingredients except for the active agent itself.
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Active Comparator: Lorazepam or PLC
Single dose of lorazepam (1mg) or PLC
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Oral administration of 1mg lorazepam
Other Names:
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
Sponsor
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Autonomic Agents
- Peripheral Nervous System Agents
- Antiemetics
- Gastrointestinal Agents
- Tranquilizing Agents
- Psychotropic Drugs
- Hypnotics and Sedatives
- Anti-Anxiety Agents
- GABA Modulators
- GABA Agents
- Anticonvulsants
- Reproductive Control Agents
- Oxytocics
- Oxytocin
- Lorazepam
Other Study ID Numbers
- LOXY
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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