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Erythropoietin

Phase 2

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment83

FDA Designations

No designations recorded

Clinical trial landscape

Erythropoietin · 1 trial · 1 indication

Phase 2 1
NCT00916552Effects of Erythropoietin on Depressive Symptoms and Neurocognitive Deficits in Depression and Bipolar DisorderMood Disorders
COMPLETED83 Analytics
PHASE2COMPLETED
Effects of Erythropoietin on Depressive Symptoms and Neurocognitive Deficits in Depression and Bipolar Disorder
Mood Disorders
NCT0091655283
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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 to 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 (matched to "Mood Disorders")

CompanyTickerTrialsLead PhaseDrugs
Neurocrine Biosciences, Inc.NBIX4PHASE3Crinecerfont
Crinetics Pharmaceuticals IncCRNX4PHASE3Atumelnant
AstraZeneca PLCAZN1PHASE3Baxdrostat
Corcept Therapeutics Incorporated.CORT1PHASE2relacorilant
Perspective Therapeutics, Inc.CATX1PHASE1VMT-α-NET
BridgeBio Pharma, Inc.BBIO1PHASE1AAV BBP-631
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Frequently asked questions about Erythropoietin

What is Erythropoietin used for in mood disorders?

Erythropoietin is being investigated for the treatment of mood disorders, including depression and bipolar disorder. It is in Phase 2 clinical development for this psychiatric indication. The drug is being studied for its effects on depressive symptoms and neurocognitive deficits in these conditions.

Who is developing Erythropoietin for mood disorders?

Novo Nordisk A/S (ticker: NVO) is developing Erythropoietin for mood disorders. The drug is currently in Phase 2 clinical development for this psychiatric indication. The company is conducting research to evaluate its effects on depressive symptoms and cognitive function in patients with depression and bipolar disorder.

What phase is Erythropoietin in for mood disorders?

Erythropoietin is in Phase 2 clinical development for mood disorders. It is an investigational drug and has not yet been approved for this indication. One Phase 2 trial has been completed, which enrolled 83 participants with mood disorders, including depression and bipolar disorder.

What clinical trials has Erythropoietin been in for mood disorders?

Erythropoietin has been studied in one clinical trial, NCT00916552, titled "Effects of Erythropoietin on Depressive Symptoms and Neurocognitive Deficits in Depression and Bipolar Disorder." This Phase 2 trial was completed and enrolled 83 participants in Denmark. The study was randomized and double-blind.

Is Erythropoietin FDA approved for mood disorders?

Erythropoietin is not FDA approved for mood disorders. It is an investigational drug currently in Phase 2 clinical development for this psychiatric indication. The drug has completed one clinical trial for mood disorders, but it remains under investigation and has not received regulatory approval for this use.