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olanzapine pamoate depot

Phase 3

Schizophrenia | Small molecule | Psychiatry |Eli Lilly and Company|Last Updated: Jan 23, 2012

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment524

FDA Designations

No designations recorded

Clinical trial landscape

olanzapine pamoate depot · 1 trial · 1 indication

Phase 3 1
NCT00320489Olanzapine Pamoate Depot Versus Oral Olanzapine on Treatment Outcomes in Outpatients With SchizophreniaSchizophrenia
COMPLETED524 Analytics
PHASE3COMPLETED
Olanzapine Pamoate Depot Versus Oral Olanzapine on Treatment Outcomes in Outpatients With Schizophrenia
Schizophrenia
NCT00320489524
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Study Endpoints

Primary Endpoints

Median Time to Discontinuation for Any Reason (Excluding Sponsor Decision)
Baseline up to 104 weeks

Secondary Endpoints

Change From Baseline in Heinrich-Carpenter Quality of Life in Schizophrenia Scale (QLS) Total Score at 104 Weeks
Baseline, 104 weeks
Change From Baseline in 36-Item Short Form Health Survey (SF-36) at 104 Weeks, All Domains and Summary Scores
Baseline, 104 weeks
Change From Baseline in Overall Health Status Assessment Using the EuroQol: 5 Dimensions Questionnaire (EQ-5D) at 104 Weeks
Baseline, 104 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Olanzapine Pamoate DepotEXPERIMENTALOlanzapine pamoate depot
OlanzapineACTIVE_COMPARATOROral olanzapine

Interventions

NameTypeDescription
olanzapineDRUG10 milligrams (mg), oral tablets, once daily for 4 weeks followed by 5-20 mg flexible dosing, oral tablets, once daily, for 100 weeks, for a total treatment duration of 104 weeks.
olanzapine pamoate depotDRUG405 milligrams (mg), intramuscular injection, followed 4 weeks later by 150-405 mg flexible dosing, intramuscular injection, every 4 weeks thereafter for 96 weeks, for a total treatment duration of 104 weeks.
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersNo
Study Sites49

Inclusion Criteria: * Clinical diagnosis of schizophrenia * Must be an outpatient (not requiring hospitalization) now and for at least the past 8 weeks. * Disease symptoms must meet a certain range as assessed by the clinician. * Patient has experienced at least two episodes of clinical worsening o...

Countries:United StatesArgentinaBrazilCanadaFranceGreecePortugalPuerto RicoRomaniaSlovakiaSpainTaiwan
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Competitive Landscape -Schizophrenia 36 trials

CompanyTickerTrialsLead PhaseDrugs
Neurocrine Biosciences, Inc.NBIX5PHASE3NBI-1117568
Bristol-Myers Squibb CompanyBMY8PHASE3KarXT
LB Pharmaceuticals, Inc.LBRX2PHASE3LB-102
Alkermes Public Limited CompanyALKS2PHASE3OLZ/SAM
Vanda Pharmaceuticals Inc.VNDA1PHASE3iloperidone
Eli Lilly and CompanyLLY2PHASE2Brenipatide
Novartis AG Sponsored ADRNVS1PHASE2GXV813
Reviva Pharmaceuticals Holdings, Inc.RVPH1PHASE3Brilaroxazine
AbbVie, Inc.ABBV1PHASE2Emraclidine
Alto Neuroscience, Inc.ANRO1PHASE2ALTO-101
Anavex Life Sciences Corp.AVXL1PHASE2ANAVEX3-71
Minerva Neurosciences IncNERV1PHASE3Roluperidone, risperidone, aripiprazole, olanzapine
MapLight Therapeutics, Inc.MPLT1PHASE2ML-007C-MA
BioXcel Therapeutics, Inc.BTAI1PHASE1BXCL501 80 Micrograms, BXCL501 120 Micrograms, BXCL501 60 Micrograms
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