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Paroxetine treatment during 8 weeks

Phase 1

Social Phobia | Small molecule | Psychiatry |GSK plc|Last Updated: Jul 18, 2017

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment56

FDA Designations

No designations recorded

Clinical trial landscape

Paroxetine treatment during 8 weeks · 1 trial · 1 indication

Phase 1 1
NCT00470483A Study To Compare Emotional Changes In Subjects With Social Anxiety DisorderSocial Phobia
COMPLETED56 Analytics
PHASE1COMPLETED
A Study To Compare Emotional Changes In Subjects With Social Anxiety Disorder
Social Phobia
NCT0047048356
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Study Endpoints

Primary Endpoints

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 Endpoints

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
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
arm 1ACTIVE_COMPARATORParoxetine treatment during 8 weeks
arm 2PLACEBO_COMPARATORPlacebo treatment during 8 weeks

Interventions

NameTypeDescription
Placebo treatment during 8 weeksDRUGcomparator
Paroxetine treatment during 8 weeksDRUGtreatment drug
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Eligibility Criteria

Age Range18 Years to 60 Years
SexALL
Healthy VolunteersYes
Study Sites1

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 ta...

Countries:Spain
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