CompletedPhase 3ACTRN12607000141448

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

A placebo-controlled, randomised phase III trial investigating the effects of oxytocin, a neuropeptide, on the neural circuit (i.e. amgydala) involved in threat processing in Generalised Social Anxiety Disorder using functional magnetic resonance imaging (fMRI).


Sponsor

School of Psychology, Psychiatry and Psychological Medicine, Monash University

Enrollment

40 participants

Start Date

Mar 12, 2008

Study Type

Interventional

Conditions

Summary

The proposed study will examine if intranasal oxytocin can modulate the neural circuitry (especially the amygdala) response to threat in patients with Generalised Social Anxiety Disorder (GSAD). Two treatment conditions are involved: Oxytocin vs. Placebo. Participants (20 GSAD, 20 healthy controls) are required to undergo two functional magnetic resonsonance imaging (fMRI) sessions during which they will be asked to complete two emotional facial expression tasks. It is hypothesised that under placebo, patients with GSAD will show exaggerated amygdala activity as well as functional connectivity to threatening (i.e. angry and fearful) facial stimuli compared to healthy controls. Under oxytocin, such effects will be absent and amgydala activation and functional connectivity during threat processing will be reduced.


Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 55 Yearss

Plain Language Summary

Simplified for easier understanding

This trial uses brain imaging (fMRI) to study whether oxytocin nasal spray can reduce anxiety-related brain activity in people with generalized social anxiety disorder. It is for right-handed, non-smoking adults who are not on psychiatric medications or hormonal contraceptives. Participants undergo brain scans while viewing emotional images after receiving either oxytocin or a placebo.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Two intranasal treatment conditions: (1) Oxytocin Nasal Spray (24IU or 40.3mg) and (2) Placebo.

Two intranasal treatment conditions: (1) Oxytocin Nasal Spray (24IU or 40.3mg) and (2) Placebo. Administration at 50 mins prior to fMRI scanning procedure. There is a minimum washout period of 1 week in between 2 fMRI sessions. The two groups, involving patients with Generalised Social Anxiety Disorder (GSAD) and healthy controls, will both receive the same interventions (placebo and oxytocin) during the time span of the study, but in different sequences during the study. All participants act as their own control due to placebo condition. However it is also of interest to compare the group of Generalised Social Anxiety Disorder patient with a control/comparison group of healthy controls. The allocation of the conditions is blinded and randomised.


Locations(1)

Australia

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ACTRN12607000141448