The effect of oxytocin is investigated in social processing of social phobic patient and healthy controls MedDRA version: 12.0 Level: LLT Classification code 10041250 Term: Social phobia
Conditions
Interventions
Trade Name: Syntocinon®
Product Name: Syntocinon®
Pharmaceutical Form: Nasal spray*
CAS Number: 50-56-6
Other descriptive name: OXYTOCIN
Concentration unit: IU/ml international unit(s)/millilitre
Co
Sponsors
Rheinisch-Westfälisch Technische Hochschule Aachen
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Age between 18 and 45, Full capacity to understand and execute instructions of the study, For patients: diagnosis of social phobia according to ICD-10 using a minimal score of 19 in the Social Phobia Inventory (SPIN, patient assessment) and 55 points in the Liebowitz Anxiety Scale (LAS, assessment by interviewer) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Sinistrality Neurological or Somatic illness affecting the cerebral function (e.g. Parkinsons Disease, Epilepsy, Multiple Sclerosis, Brain Tumor) Psychiatric disorder according to ICD-10-WHO F0-F3, F8 Psychiatric disorder according to ICD-10-WHO F (applicable in patients only in untreated or if acute occurrence in the last six months Exclusion criteria of MRI (incorporated metal) Positive drug test Consumption of centrally acting substances persons commited governmental or legaly to an institution Additionally in women: current of former pregnancy,
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The study approaches the effect of oxytocin on social interaction in social phobia using -the fMRI-BOLD-response (BOLD=blood oxygen level dependent) to draw inferences of social processing and neuronal correlates -and investigate a interrelation of reaction time and behavioural effects. ;Secondary Objective: The hormone level of the steroid hormones testosterone, progesterone und estradiole in the blood plasma are used to investigate the interaction of individul hormone levels and oxytocin action.;Primary end point(s): Primary enpoints are (1) the BOLD contrast quantified with fMRI (2) evaluation of hormone levels | — |
Countries
Germany
Outcome results
None listed