A Study To Compare Emotional Changes In Subjects With Social Anxiety Disorder

NCT00470483 | Completed Phase 1

• 1 other identifier: TMT106386
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

To compare by neuroimaging techniques the way Social Anxiety patients respond to public speaking before and after a drug administration

Conditions

Social Phobia

Keywords

PET; Social Anxiety Disorder; fRMI

Outcome Measures

Primary Outcomes (1)

• fMRI BOLD response in the amygdala and insula elicited by the Matching Emotional Face paradigm at baseline and after 8 weeks of treatment. State-anxiety inventory (STAI-S) after the Public Speaking challenge (only patients).

  baseline and after 8 weeks

Secondary Outcomes (1)

• fMRI BOLD response in selected neuroanatomical ROI elicited by the by Resting State and by other exploratory paradigms at baseline (all subjects) and after 8 weeks of treatment with paroxetine compared to placebo (only patients).

  baseline and after 8 weeks

Study Arms (2)

arm 1

ACTIVE COMPARATOR

Paroxetine treatment during 8 weeks

Drug: Paroxetine treatment during 8 weeks

arm 2

PLACEBO COMPARATOR

Placebo treatment during 8 weeks

Drug: Placebo treatment during 8 weeks

Interventions

Placebo treatment during 8 weeks DRUG

comparator

arm 2

Paroxetine treatment during 8 weeks DRUG

treatment drug

Also known as: Placebo treatment during 8 weeks

arm 1

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Outpatient with Social Anxiety Disorder
• The subject is healthy
• Willing to restrict alcohol intake
• Capable of giving informed consent

You may not qualify if:

• Subjects with depression or any other psychiatric condition
• Subjects positive for HIV or hepatitis
• Subjects taking drugs or other medication
• Pregnant or becoming pregnant during the study
• Subjects who have donated blood
• Subjects who are left-handed
• Subjects with claustrophobia
• Subjects with an electronic device or ferromagnetic metal foreign body

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Barcelona, E-08003, Spain

Location

Related Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
• Results for study TMT106386 can be found on the GSK Clinical Study Register.

MeSH Terms

Conditions

Phobia, Social

Condition Hierarchy (Ancestors)

Phobic Disorders; Anxiety Disorders; Mental Disorders

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2007
• First Posted: May 7, 2007
• Study Start: January 22, 2007
• Primary Completion: January 7, 2009
• Study Completion: January 7, 2009
• Last Updated: July 18, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will share

Locations

ES (1)