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Paroxetine treatment during 8 weeks

Phase 1

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

Paroxetine treatment during 8 weeks development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since May 2007

Paroxetine treatment during 8 weeks target and mechanism

Molecular targetSLC6A4
Target classInhibitor
ModalitySmall molecule
ChEMBLCHEMBL490

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

Paroxetine treatment during 8 weeks clinical trials

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 PhobiaUnlock trial analytics

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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Frequently asked questions about Paroxetine treatment during 8 weeks

What is paroxetine treatment during 8 weeks?

Paroxetine treatment during 8 weeks refers to an 8-week course of the small molecule paroxetine, developed by GSK plc (ticker GSK), studied in a Phase 1 trial for social phobia, also called social anxiety disorder. The trial was randomized, double-blind, and placebo-controlled, enrolling 56 participants in Spain.

What does paroxetine target?

Paroxetine targets SLC6A4, the serotonin transporter, and acts as an inhibitor of this target. By inhibiting SLC6A4, paroxetine affects serotonergic signaling, which is the mechanism explored in its clinical development for psychiatric conditions such as social phobia.

Who makes paroxetine treatment during 8 weeks?

GSK plc, which trades under the ticker GSK, is the developer of paroxetine treatment during 8 weeks. GSK sponsored the Phase 1 study of this small molecule in social phobia, and the company is identified as the developer of the asset.

What phase is paroxetine treatment during 8 weeks in?

Paroxetine treatment during 8 weeks is in Phase 1 development. The single listed trial, NCT00470483, is a completed Phase 1 study. The drug is investigational and is not described as approved for social phobia based on this development program.

What clinical trials is paroxetine treatment during 8 weeks in?

Paroxetine treatment during 8 weeks has been studied in one clinical trial, NCT00470483, titled A Study To Compare Emotional Changes In Subjects With Social Anxiety Disorder. This completed Phase 1 trial enrolled 56 participants in Spain, was randomized, double-blind, and placebo-controlled, and included healthy volunteers aged 18 years and older.