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

Phase 4

• Conditions: F40.1; Social phobias

• Registration Number: DRKS00000403
• Lead Sponsor: Rheinisch-Westfälische Technische Hochschule Aachenvertretn durch das CTC-A derMedizinischen Fakultät der RWTH Aachen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-05-10
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 96

Inclusion Criteria

inclusion criteria for control group:
Age between 18 and 45,
Full capacity to understand and execute instructions of the study,
signed form of consent.

inclusion criteria for patient group:
Age between 18 and 45,
diagnosis of social phobia (according to ICD-10),
The screening methods applied are the Social Phobia Inventory (SPIN, patient assessment) using a minimal score of 19 and the Liebowitz Anxiety Scale (LAS, assessment by interviewer, minimal score of 55 points),
Full capacity to understand and execute instructions of the study,
signed form of consent.

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)

Incorporated metal

Positive drug test and accordingly supposed or actual alcohol or drug abuse

Consumption of centrally acting substances (Except therapeutic in patients)

Persons committed governmental or legally to an institution

Any other medical condition or treatment that could interfere with the security, tolerance or efficacy in appraisal of the investigators

Participation in other or interfering clinical studies concurrently or in the last 90 days or 5 half-lives of the medical substance, respectively (whichever is longer), before screening

hormonal contraception

Individuals in dependence or working relationship with the sponsor or PI

Additionally in women: current of former pregnancy

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The BOLD response quantified with fMRI (in 3T MRI scanner) after application of oxytocin/placebo.

Secondary Outcome Measures

Name	Time	Method
Hormone serum levels of oxytocin, progesterone, testosterone, estradiol from blood taken at several time points in the course of the study.