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Geodon

Phase 3FDA approved 2001

Bipolar Disorder | Small molecule | Psychiatry |Viatris Inc.|Trials Updated: Mar 29, 2021

Geodon development status

FDA approval Feb 5, 2001
Approval holderViatris
ApplicationNDA020825
Highest phase Phase 3

Label indication GEODON is indicated for the treatment of schizophrenia, as monotherapy for the acute treatment of bipolar manic or mixed episodes, and as an adjunct to lithium or valproate for the maintenance treatment of bipolar disorder. GEODON intramuscular is indicated for acute agitation in schizophrenic patients. FDA label

Geodon target and mechanism

ModalitySmall molecule

Also known as Geodon (Ziprasidone)

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials2
Total Enrollment928

FDA Designations

No designations recorded

Geodon clinical trials

Geodon · 2 trials · 1 indication

Phase 3 2
NCT00282464A Six-week Flexible Dose Study Evaluating the Efficacy and Safety of Geodon in Patients With Bipolar I Depression.Bipolar Disorder
COMPLETED392 Analytics
NCT00141271A Six-Week Study Evaluating The Efficacy And Safety Of Geodon In Patients With A Diagnosis Of Bipolar I DepressionBipolar Disorder
COMPLETED536 Analytics
PHASE3COMPLETED
A Six-week Flexible Dose Study Evaluating the Efficacy and Safety of Geodon in Patients With Bipolar I Depression.
Bipolar Disorder
NCT00282464392
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PHASE3COMPLETED
A Six-Week Study Evaluating The Efficacy And Safety Of Geodon In Patients With A Diagnosis Of Bipolar I Depression
Bipolar Disorder
NCT00141271536
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Study Endpoints

Primary Endpoints

Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
Baseline to Week 6

Change is observed value at each visit minus baseline value. MADRS:10-item instrument measuring depression; scale range between 0(Normal) - 6(most abnormal)for each item. Total possible score is 0 - 60. Overall is average response Week 1 - Week 6.

Change in Montgomery-Asberg Depression Rating Scale (MADRS)Total Score
Baseline to 6 weeks

Change is observed value at each visit minus baseline value. Overall is average response of Weeks 1 - 6. MADRS is 10-item instrument measuring depression; scale 0(Normal) and 6(most abnormal). Total possible score is 0 - 60.

Secondary Endpoints

Response Greater Than or Equal to 50 Percent Decrease From Baseline in Montgomery-Asberg Rating Scale (MADRS) Total Score
Baseline to Week 6
Response Greater Than or Equal to 50 Percent Decrease From Baseline in Hamilton Depression Rating Scale (HAM-D 17) Total Score
Baseline to Week 3, Week 6
Remission as Measured by Montgomery Asberg Depression Scale (MADRS) Total Score Less Than or Equal to 12
Week 1 to Week 6
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Ziprasidone 20 and 60mgACTIVE_COMPARATORFor the Ziprasidone arm, the Baseline card will contain 20 mg bid (one 20 mg capsule) for days 1-2 and 40 mg bid (two 20 mg capsules) for days 3-6. Cards A, B, C, and D will contain either 20 mg bid (one 20 mg capsule), 40 mg bid (two 20 mg capsules), 60 mg bid (one 60 mg capsule), or 80 mg bid (one 60 mg capsule and one 20 mg capsule).
PlaceboPLACEBO_COMPARATOR -
20-40mg BID armACTIVE_COMPARATOR -
60-80mg bid armACTIVE_COMPARATOR -

Interventions

NameTypeDescription
PlaceboDRUGSubjects will start on placebo and remain on placebo for six weeks. All cards for the Placebo arm will be 0 mg bid.
Geodon (Ziprasidone)DRUGZiprasidone flexible dosing treatment arm (20-80 mg bid). For the Ziprasidone arm, the Baseline card will contain 20 mg bid (one 20 mg capsule) for days 1-2 and 40 mg bid (two 20 mg capsules) for days 3-6. Cards A, B, C, and D will contain either 20 mg bid (one 20 mg capsule), 40 mg bid (two 20 mg capsules), 60 mg bid (one 60 mg capsule), or 80 mg bid (one 60 mg capsule and one 20 mg capsule).
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites43

Inclusion Criteria: * Subjects must have a primary diagnosis of Bipolar I Disorder, most recent episode depressed, with or without rapid cycling, without psychotic features, as defined in DSM-IV-TR (296.5X) and confirmed by a structured Mini International Neuropsychiatric Interview (MINI) Exclusio...

Countries:United States
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Competitive Landscape -Bipolar Disorder 22 trials

Top 10 of 11 competitors

CompanyTickerTrialsLead PhaseDrugs
Bristol-Myers Squibb CompanyBMY4PHASE3Xanomeline and trospium chloride, Xanomeline/Trospium Chloride
AbbVie, Inc.ABBV3PHASE3Cariprazine, ABBV-932, Icalcaprant
Xenon Pharmaceuticals Inc.XENE2PHASE3Azetukalner
Eli Lilly and CompanyLLY1PHASE2Brenipatide
Rapport Therapeutics, Inc.RAPP1PHASE2RAP-219
Neurocrine Biosciences, Inc.NBIX1PHASE2NBI-1117568
Alto Neuroscience, Inc.ANRO1PHASE2ALTO-100
LB Pharmaceuticals, Inc.LBRX1PHASE2LB-102
BioXcel Therapeutics, Inc.BTAI1PHASE1BXCL501
Alzamend Neuro, Inc.ALZN1PHASE1AL001
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