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GW597599B

Phase 2

Depressive Disorder, Major | Small molecule | Other |GSK plc|Last Updated: Oct 9, 2017

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-BlindUNCONTROLLED
Total Trials1
Total Enrollment372
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00048204A Study Of A New Medicine (GW597599B) For The Treatment Of Major Depressive DisorderPHASE2 COMPLETED 372Nov 4, 2002Sep 30, 2003Oct 9, 2017 -
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Study Endpoints
Primary Endpoints
Hamilton Depression Rating Scale
8 Weeks
Secondary Endpoints
Hamilton Depression Rating Scale Clinical Global Impression-Global Improvement Clinical Global Impression-Severity of Illness Hospital Anxiety and Depression Scale
8 Weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
GW597599BDRUG -
paroxetineDRUG -
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Patients meet the diagnosis of Major Depressive Disorder (MDD). Exclusion Criteria: * Patients with a primary diagnosis other than MDD. * Patients with a history of schizophrenia, schizoaffective disorders, seizure disorders or bipolar affective disorder. * Patients receivin...

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