Healthy Male VolunteersPhase 1NCT01607970
Oxytocin Modulation of Startle Reactivity to Social Stimuli and Moral Decision Making
A Phase 1 study testing Oxytocin in people with Healthy Male Volunteers, run by University Hospital, Bonn at 1 site in Germany.
Trial summary
The purpose of this study is to determine whether oxytocin affects the modulation of startle reactivity by aversive social stimuli and to investigate the oxytocin effect on moral judgements. Read more about this study
- Who is it for?
- Ages 18 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Male Volunteers
- What is being tested?
- Oxytocin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2011to May 2012
- 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 60 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male volunteers
Who cannot join
- Current or past psychiatric disease
- Current or past physical illness
- Psychoactive medication
- Tobacco smokers
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Double-blind, Placebo-controlled, Randomized Study: Oxytocin Modulation of Startle Reactivity to Social Stimuli and Moral Decision Making
The purpose of this study is to determine whether oxytocin affects the modulation of startle reactivity by aversive social stimuli and to investigate the oxytocin effect on moral judgements. Furthermore the investigators explore the effects of oxytocin receptor (OXTR) polymorphisms on behavioral responses to social stimuli.
Read the detailed description
The neuropeptide oxytocin (OXT) can enhance the impact of positive social cues but may reduce that of negative ones, although it is unclear whether the latter causes blunted emotional responses. After OXT or placebo application participants are exposed to acoustic startle probes presented alone and during viewing of 60 color pictures mostly selected from the 'International Affective Picture System'. The paradigm featured 20 negative (mostly threatening), 20 neutral, and 20 positive pictures, presented for 5 s each. In the other part of the experiment, after intranasal OXT or placebo application participants respond to 60 moral dilemmas.
- Conditions
- Healthy Male Volunteers
- Being tested
- Oxytocin
- Keywords
- Oxytocin, Startle, moral dilemma, oxytocin receptor gene
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxytocinDrug
Also called Oxytocin: Syntocinon-Spray, Novartis
Oxytocin: 24 IU; 3 puffs per nostril, each with 4 IU OXT
| Study group | Role | What they receive |
|---|---|---|
| Oxytocin | Experimental | 24 IU Oxytocin, intranasal application 45 min prior to the experiment Receives: Drug: Oxytocin |
| Placebo | Placebo comparator | intranasal application, sodium chloride solution, 3 puffs per nostril Receives: Drug: Oxytocin |
What is being measured
The primary outcome is the main question the study is designed to answer.
baseline startle magnitude and affective modulation of the startle magnitude after oxytocin and placebo administration
The experimental tasks started 45 min after intranasal OXT/PLC administration. The STARTLE-paradigm features 20 negative (mostly threatening), 20 neutral, and 20 positive pictures, presented for 5 s each. The startle stimulus consists of a single 50-ms burst of white noise (100 dB) with nearly instantaneous rise and was delivered binaurally via headphones during 60% of the pictures (i.e. 12 from each category) at 2 - 4 s after picture onset. We examined the baseline startle magnitude as well as the affective modulation of the startle magnitude.
Measured: 24 Months
Secondary outcomes (2)
moral decision making after oxytocin and placebo administration
The experimental tasks started 45 min after OXT/PLC administration. The moral dilemmas performed in the present study were identical to those published previously by Greene et al.(2001).
Measured: 24 months
oxytocin receptor (OXTR) polymorphism and correlation with social behavior
OXTR genotyping, social behavior testing
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2012 (estimated)
- Study startAug 2011
- Primary completionMay 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Male VolunteersStudies 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
- 80 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
- Investigators
- Rene Hurlemann, MSc MD PhD, Principal investigator, Department of Psychiatry, University of Bonn, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01607970
- Sponsor's protocol ID
- OXT-168/11
- Status last verified
- May 2012
- First submitted
- 23 May 2012
- Last updated
- 30 May 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-blind, Placebo-controlled, Randomized Study: Oxytocin Modulation of Startle Reactivity to Social Stimuli and Moral Decision Making
- ClinicalTrials.gov ID
- NCT01607970
- Acronym / sponsor ID
- OXT-168/11
- Conditions
- Healthy Male Volunteers
- Keywords
- Oxytocin, Startle, moral dilemma, oxytocin receptor gene
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University Hospital, BonnUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 30 May 2012 (estimated)
- 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.
The purpose of this study is to determine whether oxytocin affects the modulation of startle reactivity by aversive social stimuli and to investigate the oxytocin effect on moral judgements. Furthermore the investigators explore the effects of oxytocin receptor (OXTR) polymorphisms on behavioral responses to social stimuli.
Detailed description
The neuropeptide oxytocin (OXT) can enhance the impact of positive social cues but may reduce that of negative ones, although it is unclear whether the latter causes blunted emotional responses. After OXT or placebo application participants are exposed to acoustic startle probes presented alone and during viewing of 60 color pictures mostly selected from the 'International Affective Picture System'. The paradigm featured 20 negative (mostly threatening), 20 neutral, and 20 positive pictures, presented for 5 s each. In the other part of the experiment, after intranasal OXT or placebo application participants respond to 60 moral dilemmas.
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 | Experimental | Drug: Oxytocin24 IU Oxytocin, intranasal application 45 min prior to the experiment |
| Placebo | Placebo comparator | Drug: Oxytocinintranasal application, sodium chloride solution, 3 puffs per nostril |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy male volunteers
Key exclusion criteria (4 listed)
- Current or past psychiatric disease
- Current or past physical illness
- Psychoactive medication
- Tobacco smokers
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: Oxytocin: Syntocinon-Spray, NovartisOxytocin: 24 IU; 3 puffs per nostril, each with 4 IU OXT | Drug | Oxytocin, Placebo |
Primary outcome
baseline startle magnitude and affective modulation of the startle magnitude after oxytocin and placebo administration
Time frame: 24 Months
The experimental tasks started 45 min after intranasal OXT/PLC administration. The STARTLE-paradigm features 20 negative (mostly threatening), 20 neutral, and 20 positive pictures, presented for 5 s each. The startle stimulus consists of a single 50-ms burst of white noise (100 dB) with nearly instantaneous rise and was delivered binaurally via headphones during 60% of the pictures (i.e. 12 from each category) at 2 - 4 s after picture onset. We examined the baseline startle magnitude as well as the affective modulation of the startle magnitude.
2 secondary outcomes
moral decision making after oxytocin and placebo administration
Time frame: 24 months
oxytocin receptor (OXTR) polymorphism and correlation with social behavior
Time frame: 24 months
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 30 May 2012.
- Click here for more information about the NEMO research groupLink provided by the sponsor.
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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.
Rene Hurlemann, MSc MD PhD principal investigator
Department of Psychiatry, University of Bonn, Germany
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 in people with Healthy Male Volunteers, 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 1 inclusion and 4 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 30 May 2012. 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. Some participants in this study may receive a placebo. 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?
baseline startle magnitude and affective modulation of the startle magnitude after oxytocin and placebo administration (time frame: 24 Months). 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 30 May 2012.