Effects of Oxytocin on Amygdala Response to Threat in Generalised Social Anxiety Disorder: A Functional Magnetic Resonance Imaging (fMRI) Study

Phase 3

Completed

• Conditions: Generalised Social Anxiety Disorder; Mental Health - Anxiety

• Registration Number: ACTRN12607000141448
• Lead Sponsor: School of Psychology, Psychiatry and Psychological Medicine, Monash University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-02-23
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Right-handed, non-smokers, psychotropic medication free for a minimum of 2 weeks (8 weeks for fluoxetine, 4 weeks for monoamine oxidase inhibitors), not taking hormonal contraceptives, and do not have comorbid alcohol or substance abuse or dependence. Additional inclusion for GSAD participants - Diagnostic and Statistical Manual of Mental Disorders 4th edition (DSM-IV) GSAD as primary diagnosis.

Exclusion Criteria

Clinically significant medical or neurologic condition (not applicable to GSAD patients, see inclusion criteria), current/recent depressive episode, life history of bipolar, schizophrenia, obsessive compulsive disorder, post-traumatic stress disorder or presence of organic mental syndrome, mental retardation, or pervasive developmental disorder, pregnancy or lactation, presence of ferrous-containing metals within the body, inability to tolerate small, enclosed spaces without anxiety.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
fMRI data will be collected to investigate whether oxytocin affects the amygdala response to threatening (vs. non-threatening) facial expression processing in patients with Generalised Social Anxiety Disorder (GSAD) relative to healthy controls.[50 minutes post drug administration]

Secondary Outcome Measures

Name	Time	Method
The fMRI data collected 50 minutes post drug adminstration will also be used to investigate the effects of oxytocin (vs. placebo) on functional connectivity (ie. Amygdala-Brainstem, Amygdala-Insula) in patients with Generalised Anxiety Disorder (GSAD) compared to healthy controls.[Functional connectivity will be investigated during the analysis using correlation analysis, which is done post data collection during data analysis. This data used is collected at 50 minutes post drug administration.]