Clinical trial NCT00723606: A Randomized, Open-Label, Multi-Center Study To Evaluate The Efficacy And Safety Of Intramuscular Ziprasidone In Patients With Agitation
Official title: A Randomized, Open Label, Rater Blind, Flexible Dose Multi-Center Study Comparing The Efficacy And Safety Of Intramuscular Ziprasidone With Haloperidol For Three Days In Patients With Agitation Of Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Schizophrenia
Keywords: Intramuscular ziprasidone, agitation, efficacy and safety
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-07-29
Enrollment: 376
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Primary outcomes:
measure: Change From Baseline in Brief Psychiatric Rating Scale (BPRS) Total Scores at 72 Hours
timeFrame: Baseline, 72 hours
Secondary outcomes:
measure: BPRS Agitation Subscale Response at 72 Hours
timeFrame: 72 hours
measure: Change From Baseline in BPRS Agitation Subscale Score at 72 Hours
timeFrame: Baseline, 72 hours
measure: Clinical Global Impression-Improvement (CGI-I) Score at 72 Hours
timeFrame: 72 hours
measure: Change From Baseline in Clinical Global Impressions Severity (CGI-S) Score at 72 Hours
timeFrame: Baseline, 72 hours
measure: Change From Baseline in Behavioral Activity Rating Scale (BARS) at 72 Hours
timeFrame: Baseline, 72 hours
Other outcomes:
Locations:
city: Baoding
country: China
facility: Pfizer Investigational Site
state: Hebei
city: Wuhan
country: China
facility: Pfizer Investigational Site
state: Hubei
city: Kunming
country: China
facility: Pfizer Investigational Site
state: Yunnan
city: Beijing
country: China
facility: Pfizer Investigational Site
city: Beijing
country: China
facility: Pfizer Investigational Site
city: Chang Sha
country: China
facility: Pfizer Investigational Site
city: Guangzhou
country: China
facility: Pfizer Investigational Site
city: Nanjing
country: China
facility: Pfizer Investigational Site
city: Xi'an
country: China
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Zhang H, Wang G, Zhao J, Xie S, Xu X, Shi J, Deng H, Li K, Gao C, Wang X, Vanderburg D, Pan S, Tang H, Shu L, Karayal ON. Intramuscular ziprasidone versus haloperidol for managing agitation in Chinese patients with schizophrenia. J Clin Psychopharmacol. 2013 Apr;33(2):178-85. doi: 10.1097/JCP.0b013e3182839612.