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paroxetine hydrate

Phase 3

Social Phobia | Small molecule | Psychiatry |GSK plc|Last Updated: Apr 15, 2013

Target and mechanism

ModalitySmall molecule

Also known as paroxetine hydrochloride hydrate, Paroxetine hydrochloride hydrate

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment390

FDA Designations

No designations recorded

Clinical trial landscape

paroxetine hydrate · 1 trial · 1 indication

Phase 3 1
NCT00318669Social Anxiety Disorder Study Of ParoxetineSocial Phobia
COMPLETED390 Analytics
PHASE3COMPLETED
Social Anxiety Disorder Study Of Paroxetine
Social Phobia
NCT00318669390
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Study Endpoints

Primary Endpoints

Change from baseline in the LSAS total score at week 12 (Score at week 12 - Score at week 0)
12 Weeks

Secondary Endpoints

Proportion of patients responding with a CGI Global Improvement Item score. Change from baseline in the CGI Severity of Illness score. Change from baseline in the HAM-D total score. Proportion of patients continuing treatment.
12 Weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Interventions

NameTypeDescription
Paroxetine hydrochloride hydrateDRUG -
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Eligibility Criteria

Age Range18 Years to 64 Years
SexALL
Healthy VolunteersNo
Study Sites16

Inclusion criteria: * Diagnosis of Social Anxiety Disorder (SAD) (300.23 Social Phobia/Social Anxiety Disorder) according to DSM-IV-TR criteria. * Must give a written informed consent. But if the patient is under 20, both the patient himself/herself and his/her proxy consenter must give written inf...

Countries:Japan
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