Effect of intranasal oxytocin on social approach in patients with social phobia and healthy control - OXT_fMRT

Conditions: The effect of oxytocin is investigated in social processing of social phobic patient and healthy controls
MedDRA version: 12.0Level: LLTClassification code 10041250Term: Social phobia

Registration Number: EUCTR2009-015538-30-DE

Lead Sponsor: Rheinisch-Westfälisch Technische Hochschule Aachen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

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

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,

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The study approaches the effect of oxytocin on social interaction in social phobia using <br>-the fMRI-BOLD-response (BOLD=blood oxygen level dependent) to draw inferences of social processing and neuronal correlates <br>-and investigate a interrelation of reaction time and behavioural effects. <br>;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<br>(1) the BOLD contrast quantified with fMRI<br>(2) evaluation of hormone levels

Secondary Outcome Measures