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Erythropoietin

Phase 2

Mood Disorders | Small molecule | Other |Novo Nordisk A/S|Last Updated: Nov 9, 2012

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-BlindUNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment83
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00916552Effects of Erythropoietin on Depressive Symptoms and Neurocognitive Deficits in Depression and Bipolar DisorderPHASE2 COMPLETED 83 — — Sep 1, 2009Oct 1, 2012Nov 9, 20121 Denmark
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Study Endpoints
Primary Endpoints
a) For treatment-resistant depressed patients: Antidepressant effect measured with the Hamilton Depression Rating Scale (HDRS); b) For bipolar patients in remission: Memory measured with the Rey Auditory Verbal Memory Test.
a) Baseline and weeks 5, 9 and 14; b) Baseline and weeks 9 and 14
Secondary Endpoints
a) For treatment-resistant depressed patients: number of remissions measured with the HDRS; b) For bipolar patients in remission: sustained attention measured with the RVIP and facial expression recognition.
a) Baseline and weeks 5, 9 and 14; b) Baseline and weeks 9 and 14
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
ErythropoeitinEXPERIMENTAL40.000 IU, epoetin alfa; Janssen-Cilag
Interventions
NameTypeDescription
ErythropoietinDRUG40.000 IU/ml epoetin alfa is administered as intravenous infusions over 15 min weekly for 8 weeks.
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Treatment-resistant depression (defined as failure to respond to at least 2 different types of antidepressants) and an HDRS score of at least 17 OR * Bipolar disorder in remission (HDRS score of max 14 and Young Mania Scale score of max 14) and subjective complaints of moder...

Countries:Denmark
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Competitive Landscape -Adrenal Disorders 15 trials
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