Oxytocin, Lorazepam, Anti-Anxiety Agents, Physiological Effects of DrugsPhase 1NCT03829839
Effects of Oxytocin and Lorazepam on Fear-related Intra-amygdalar Activity
A Phase 1 study testing Oxytocin and Lorazepam 1 mg in people with Oxytocin, Lorazepam, Anti-Anxiety Agents, Physiological Effects of Drugs, run by University Hospital, Bonn at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Oxytocin, Lorazepam, Anti-Anxiety Agents, Physiological Effects of Drugs
- What is being tested?
- Oxytocin and Lorazepam 1 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteGermany
- Study dates
- 3 Mar 2016to 16 Aug 2017
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy male volunteers
- right-handed
Who cannot join
- Current or past psychiatric illness
- Current or past physical illness
- Psychoactive medication
- Sedative medication
- MRI contraindication (e.g. metal in body, claustrophobia)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Being tested
- Oxytocin, Lorazepam 1 mg, Placebo nasalspray, Placebo Oral Tablet
- Keywords
- Amygdala, anxiety, benzodiazepines, fear, fMRI, lorazepam, oxytocin, 7 Tesla
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxytocinDrug
Also called syntocinon
Intranasal administration, 24 international units (IU) oxytocin
Lorazepam 1 mgDrug
Also called Tavor
Oral administration of 1mg lorazepam
Placebo nasalsprayDrug
The placebo nasalspray contain identical ingredients except for the active agent itself.
Placebo Oral TabletDrug
The placebo pill contain identical ingredients except for the active agent itself.
| Study group | Role | What they receive |
|---|---|---|
| Oxytocin or PLC | Active comparator | Single dose of intranasal oxytocin (24 international units) or PLC. Receives: Drug: Oxytocin; Drug: Placebo nasalspray |
| Lorazepam or PLC | Active comparator | Single dose of lorazepam (1mg) or PLC Receives: Drug: Lorazepam 1 mg; Drug: Placebo Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Neural activations with be measured with 7 Tesla fMRI in an emotional face matching task that lasts 20 mins
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2019
- Study start3 Mar 2016
- Primary completion16 Aug 2017
- Study completion16 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oxytocin, Lorazepam, Anti-Anxiety Agents, Physiological Effects of DrugsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bonn
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rene Hurlemann, University Hospital, Bonn
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03829839
- Sponsor's protocol ID
- LOXY
- Status last verified
- Apr 2019
- First submitted
- 1 Feb 2019
- Last updated
- 17 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Common and Dissociable Effects of Oxytocin and Lorazepam on the Neurocircuitry of Fear - an Ultra-high Field Imaging Study
- ClinicalTrials.gov ID
- NCT03829839
- Acronym / sponsor ID
- LOXY
- Keywords
- Amygdala, anxiety, benzodiazepines, fear, fMRI, lorazepam, oxytocin, 7 Tesla
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University Hospital, BonnUniversity, hospital or other
- Study start
- 3 Mar 2016 (actual)
- Primary completion
- 16 Aug 2017 (actual)
- Study completion
- 16 Aug 2017 (actual)
- First posted
- 4 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oxytocin or PLC | Active comparator | Drug: Oxytocin, Drug: Placebo nasalspraySingle dose of intranasal oxytocin (24 international units) or PLC. |
| Lorazepam or PLC | Active comparator | Drug: Lorazepam 1 mg, Drug: Placebo Oral TabletSingle dose of lorazepam (1mg) or PLC |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- healthy male volunteers
- right-handed
Key exclusion criteria (5 listed)
- Current or past psychiatric illness
- Current or past physical illness
- Psychoactive medication
- Sedative medication
- MRI contraindication (e.g. metal in body, claustrophobia)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OxytocinAlso: syntocinonIntranasal administration, 24 international units (IU) oxytocin | Drug | Oxytocin or PLC |
| Lorazepam 1 mgAlso: TavorOral administration of 1mg lorazepam | Drug | Lorazepam or PLC |
| Placebo nasalsprayThe placebo nasalspray contain identical ingredients except for the active agent itself. | Drug | Oxytocin or PLC |
| Placebo Oral TabletThe placebo pill contain identical ingredients except for the active agent itself. | Drug | Lorazepam or PLC |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2019.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Oxytocin and Lorazepam 1 mg in people with Oxytocin, Lorazepam, Anti-Anxiety Agents, Physiological Effects of Drugs, run by University Hospital, Bonn at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2019.