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Intramuscular ziprasidone

Phase 3

Schizophrenia | Small molecule | Psychiatry |Viatris Inc.|Trials Updated: Mar 3, 2021

Intramuscular ziprasidone target and mechanism

ModalitySmall molecule

Also known as Intramuscular ziprasidone mesylate

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment376

FDA Designations

No designations recorded

Intramuscular ziprasidone clinical trials

Intramuscular ziprasidone · 1 trial · 1 indication

Phase 3 1
NCT00723606A Randomized, Open-Label, Multi-Center Study To Evaluate The Efficacy And Safety Of Intramuscular Ziprasidone In Patients With AgitationSchizophrenia
COMPLETED376 Analytics
PHASE3COMPLETED
A Randomized, Open-Label, Multi-Center Study To Evaluate The Efficacy And Safety Of Intramuscular Ziprasidone In Patients With Agitation
SchizophreniaUnlock trial analytics

Study Endpoints

Primary Endpoints

Change From Baseline in Brief Psychiatric Rating Scale (BPRS) Total Scores at 72 Hours
Baseline, 72 hours

BPRS is an 18-item clinician rated scale with 11 general symptom items, 5 positive-symptom items, and 2 negative symptom items scored on a 7-point scale (1=not present and 7=extremely severe), with higher score indicating greater severity of symptom. Total possible score range=18 to 126. Change: score at final visit minus score at baseline.

Secondary Endpoints

BPRS Agitation Subscale Response at 72 Hours
72 hours
Change From Baseline in BPRS Agitation Subscale Score at 72 Hours
Baseline, 72 hours
Clinical Global Impression-Improvement (CGI-I) Score at 72 Hours
72 hours
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Intramuscular ziprasidoneEXPERIMENTAL -
Intramuscular haloperidolACTIVE_COMPARATOR -

Interventions

NameTypeDescription
Intramuscular ziprasidone mesylateDRUGThe recommended dose is 10 to 20 mg administered as required up to a maximum dose of 40 mg per day. Doses of 10 mg may be administered every two hours; doses of 20 mg may be administered every four hours up to a maximum of 40 mg/day for 3 days.
Intramuscular haloperidolDRUGThe haloperidol group will receive an initial intramuscular injection of haloperidol 5mg, following on which 5mg haloperidol may be repeated every 4-8 hours to a maximum of 20 mg /day for 3 days.
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersNo
Study Sites9

Inclusion Criteria: * Male or female Chinese subjects aged 18-65 years (including 65) at screening. * Subjects meeting the ICD-10 (Classification of Mental and Behavioral Disorders) criteria for schizophrenia (F20.X). * Subjects who are in acute phase of schizophrenia and are appropriate to receive...

Countries:China
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