SchizophreniaPhase 3NCT00723606
A Randomized, Open-Label, Multi-Center Study To Evaluate The Efficacy And Safety Of Intramuscular Ziprasidone In Patients With Agitation
A Phase 3 study testing Intramuscular ziprasidone mesylate and Intramuscular haloperidol in people with Schizophrenia, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 9 sites in China.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Intramuscular ziprasidone mesylate and Intramuscular haloperidol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 376 participants
- Where
- 9 sitesChina
- Study dates
- Sep 2008to Jul 2009
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
China9 sites
Pfizer Investigational Site
Baoding, Hebei, 071000
Pfizer Investigational Site
Beijing, 100083
Pfizer Investigational Site
Beijing, 100088
Pfizer Investigational Site
Changsha, 410011
Pfizer Investigational Site
Guangzhou, 510370
Pfizer Investigational Site
Kunming, Yunnan, 650032
Pfizer Investigational Site
Nanjing, 210029
Pfizer Investigational Site
Wuhan, Hubei, 430060
Pfizer Investigational Site
Xi'an
About this study
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
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
- Conditions
- Schizophrenia
- Being tested
- Intramuscular ziprasidone mesylate, Intramuscular haloperidol
- Keywords
- Intramuscular ziprasidone, agitation, efficacy and safety
- Medical subject headings
- Schizophrenia, Psychomotor Agitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intramuscular ziprasidone mesylateDrug
Also called Zeldox, Geodon
The 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 haloperidolDrug
Also called Haldol
The 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.
| Study group | Role | What they receive |
|---|---|---|
| Intramuscular ziprasidone | Experimental | Not described Receives: Drug: Intramuscular ziprasidone mesylate |
| Intramuscular haloperidol | Active comparator | Not described Receives: Drug: Intramuscular haloperidol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Brief Psychiatric Rating Scale (BPRS) Total Scores at 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.
Measured: Baseline, 72 hours
Secondary outcomes (5)
BPRS Agitation Subscale Response at 72 Hours
The BPRS agitation subscale score was composed of 4 questions (questions 2, 6, 10, 17). The BPRS agitation subscale score was obtained by summing the relevant individual items. Total possible score range=4 to 28. A response was defined as a > 30 percent reduction from baseline in BPRS agitation subscale score.
Measured: 72 hours
Change From Baseline in BPRS Agitation Subscale Score at 72 Hours
The BPRS agitation subscale score was composed of 4 questions (questions 2, 6, 10, 17). The BPRS agitation subscale score was obtained by summing the relevant individual items. Total possible score range=4 to 28. Change: score at final visit minus score at baseline.
Measured: Baseline, 72 hours
Clinical Global Impression-Improvement (CGI-I) Score at 72 Hours
CGI-I: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected.
Measured: 72 hours
Change From Baseline in Clinical Global Impressions Severity (CGI-S) Score at 72 Hours
CGI-S: 7-point clinician rated scale to assess severity of subject's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = more affected. Change: score at observation minus score at baseline.
Measured: Baseline, 72 hours
Change From Baseline in Behavioral Activity Rating Scale (BARS) at 72 Hours
BARS measures the degree of agitated behavior using a 7-point scale describing increasing levels of activity (1 =difficult or unable to rouse; 2 = asleep but responds normally to verbal or physical contact; 3 = drowsy, appears sedated; 4 = quiet and awake [normal level of activity]; 5 = signs of overt [physical or verbal] activity, calms down with instructions; 6 = extremely or continuously active, not requiring restraint; 7 = violent, requires restraint.
Measured: Baseline, 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2008 (estimated)
- Study startSep 2008
- Primary completionJul 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 376 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00723606
- Sponsor's protocol ID
- A1281152
- Status last verified
- Mar 2021
- First submitted
- 25 Jul 2008
- Last updated
- 3 Mar 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 23422376
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00723606
- Acronym / sponsor ID
- A1281152
- Conditions
- Schizophrenia
- Keywords
- Intramuscular ziprasidone, agitation, efficacy and safety
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 376 participants (actual)
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2008
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 29 Jul 2008 (estimated)
- Results
- Posted 25 Aug 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intramuscular ziprasidone | Experimental | Drug: Intramuscular ziprasidone mesylate |
| Intramuscular haloperidol | Active comparator | Drug: Intramuscular haloperidol |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intramuscular ziprasidone mesylateAlso: Zeldox, GeodonThe 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. | Drug | Intramuscular ziprasidone |
| Intramuscular haloperidolAlso: HaldolThe 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. | Drug | Intramuscular haloperidol |
Primary outcome
Change From Baseline in Brief Psychiatric Rating Scale (BPRS) Total Scores at 72 Hours
Time frame: 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.
5 secondary outcomes
BPRS Agitation Subscale Response at 72 Hours
Time frame: 72 hours
Change From Baseline in BPRS Agitation Subscale Score at 72 Hours
Time frame: Baseline, 72 hours
Clinical Global Impression-Improvement (CGI-I) Score at 72 Hours
Time frame: 72 hours
Change From Baseline in Clinical Global Impressions Severity (CGI-S) Score at 72 Hours
Time frame: Baseline, 72 hours
Change From Baseline in Behavioral Activity Rating Scale (BARS) at 72 Hours
Time frame: Baseline, 72 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 23422376Zhang 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.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Intramuscular ziprasidone mesylate and Intramuscular haloperidol in people with Schizophrenia, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 9 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Aug 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Brief Psychiatric Rating Scale (BPRS) Total Scores at 72 Hours (time frame: Baseline, 72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00723606, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2021; AzTrials last refreshed its copy on 1 Nov 2026.