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vestipitant

Phase 2

Depressive Disorder and Anxiety Disorders | Small molecule | Psychiatry |GSK plc|Last Updated: Sep 15, 2016

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindUNCONTROLLEDBiomarker
Total Trials1
Total Enrollment72
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00343707PET (Positron Emission Tomography)/Public Speaking Study With A Combination Of 2 Medications In Social Anxiety PatientsPHASE2 COMPLETED 72 — — Nov 1, 2004Nov 1, 2005Sep 15, 20161 Sweden
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Study Endpoints
Primary Endpoints
To assess, by mean of Positron Emission Tomography, the degree of regional Cerebral Blood Flow in different brain regions involved in the emotional brain circuit during public speaking task before treatment and after eight weeks of treatment.
Secondary Endpoints
To assess symptomatic and physiological measures of anxiety induced by the public speaking task and social anxiety symptoms during eight weeks of treatment. To evaluate safety, tolerability and the effect on sexual function of treatment.
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
vestipitantDRUG -
paroxetineDRUG -
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion criteria: * Social phobic ambulatory subjects, defined according to DSM-IV criteria. * Must be capable of giving informed consent and can comply with the study requirements. * Women of childbearing potential must agree to acceptable method of birth control. Exclusion criteria: * Primary...

Countries:Sweden
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