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

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 1

Conditions: Social Phobia

Treatments: Drug: Placebo treatment during 8 weeks; Drug: Paroxetine treatment during 8 weeks

Study type: Interventional

Funder types: Industry

Identifiers

NCT00470483

TMT106386

Details and patient eligibility

About

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

Enrollment: 56 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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56 participants in 2 patient groups, including a placebo group

arm 1

Active Comparator group

Description:

Paroxetine treatment during 8 weeks

Treatment:

Drug: Paroxetine treatment during 8 weeks

arm 2

Placebo Comparator group

Description:

Placebo treatment during 8 weeks

Treatment:

Drug: Placebo treatment during 8 weeks