- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02156661
Oxytocin and Emotion Processing
Study Overview
Detailed Description
An effect of OXT on emotion processing and anxiety has been broadly investigated in animal studies. However, in humans, effects seem more complex.
The rationale of the study is to examine direct effects of OXT to processing and learning of emotional and social values in humans.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Healthy male volunteers
Exclusion Criteria:
- Current or past psychiatric disease
- Current or past physical illness
- Psychoactive medication
- Tobacco smokers
- MRI contraindication
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
Placebo nasal spray
|
|
Active Comparator: Oxytocin
Oxytocin: Syntocinon-Spray, Novartis intranasal administration, 24 IU oxytocin; ; 3 puffs per nostril, each with 4 IU OXT |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Brain activity
Time Frame: During emotion processing
|
fMRI
|
During emotion processing
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Psychophysiological response
Time Frame: During stimuli presentation
|
Skin conductance response
|
During stimuli presentation
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
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
Other Study ID Numbers
- OXT-FC-14
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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