Phase 3
N=376
A Randomized, Open-Label, Multi-Center Study To Evaluate The Efficacy And Safety Of Intramuscular Ziprasidone In Patients With Agitation
Schizophrenia
Bottom Line
View on ClinicalTrials.gov: NCT00723606 ↗Enrolled (actual)
376
Serious AEs
0.0%
Results posted
Aug 2010
Primary outcome: Primary: Change From Baseline in Brief Psychiatric Rating Scale (BPRS) Total Scores at 72 Hours — -17.32; -18.44 scores on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Intramuscular ziprasidone mesylate (Drug); Intramuscular haloperidol (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Primary completion
- Jul 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Brief Psychiatric Rating Scale (BPRS) Total Scores at 72 Hours |
-17.32; -18.44 | — |
| SECONDARY BPRS Agitation Subscale Response at 72 Hours |
149; 155; 39; 29 | — |
| SECONDARY Change From Baseline in BPRS Agitation Subscale Score at 72 Hours |
-6.97; -7.45 | — |
| SECONDARY Clinical Global Impression-Improvement (CGI-I) Score at 72 Hours |
2.52; 2.55 | — |
| SECONDARY Change From Baseline in Clinical Global Impressions Severity (CGI-S) Score at 72 Hours |
-1.18; -1.21 | — |
| SECONDARY Change From Baseline in Behavioral Activity Rating Scale (BARS) at 72 Hours |
-0.93; -1.06 | — |
Summary
This local registration study is to confirm the hypothesis of the efficacy, tolerability and safety of ziprasidone IM (intramuscular) in the Chinese population with agitation in schizophrenia
Eligibility Criteria
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 intramuscular medication for at least 3 days
Exclusion Criteria
- History of clinically significant physical illness especially myocardial infarction, non compensatory heart failure etc.
- Subjects receiving an investigational agent in the previous 3 months prior to screening.
- Use of antipsychotic agents within 12 hours or parenteral benzodiazepines within 4 hours prior to randomization and during the study.
Data sourced from ClinicalTrials.gov (NCT00723606). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.