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The Efficacy And Safety Of Intramuscular Ziprasidone For Three Days In Patients With Psychotic Agitation

NCT02935998 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1000

Last updated 2016-10-18

No results posted yet for this study

Summary

1. The title of this study is a multi-center,non randomized,open-labeled,intervention study:the efficacy and safety of intramuscular ziprasidone for three days in patients with acute psychotic agitation.
2. The primary objectiveis to evaluate the efficacy of intramuscular ziprasidone in patients with acute psychotic agitation in daily clinical practice.
3. The secondary objectives are:1.To evaluate the safety of intramuscular ziprasidone in patients with acute psychotic agitation in daily clinical practice.2.To compare the efficacy and tolerance of intramuscular ziprasidone in patients with agitation in the different psychotic disorder 3.To compare the efficacy and tolerance of intramuscular ziprasidone in patients with first episode andmulti-episode patients. 4.To explore the measured based administration according to severity of symptoms.5.To compare the efficacy and tolerance of ziprasidone im between the monotherapy and combination with other antipsychotic drug in clinical practice.
4. The Rationale:In China, the studies of ziprasidone im treating agitation focus on schizophrenia. But in the foreign country, ziprasidone im also is approved to treat psychotic agitation, including bipolar and schizoaffective disorder. And in the clinical practice of China, ziprasidone im is also used to treat other patients, although the evidence is less. In this study, we assume ziprasidone im treat the psychotic agitation is effective and safe.
5. Study populations:The study plan to enroll 1000 subjects in China. （6）The background and the hypothesis：The researches of ziprasidone mesylate injection in our country are more concentrated in schizophrenia at present, while in foreign countries ziprasidone is approved for psychotic agitation, including mania etc. It's also used for substance abuse and alcohol induced agitation.Therefore, this study assumes that ziprasidone mesylate injection is effective in the treatment of acute agitation, and it's well tolerated.

Conditions

Interventions

DRUG

Ziprasidone

During the study, at least 1 injection is needed per day. Whether the second, third or fourth one is needed according to patients' symptoms. If the BARS score\>=5, clinicians are supposed to give 10mg or 20mg.If lower than 5, clinicians could choose to give 10mg or not according to patients' symptoms and doctor's experience. 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.It is not recommended to combine with other oral antipsychotic drugs. But if the patients' daily dose of injection has reached 40mg and agitation occurred 4 hours later after the last injection, with the BARS score higher than 5.The clinicians can determine whether or not to combine oral antipsychotic drug, and the dosage.

Sponsors & Collaborators

  • Pfizer

    collaborator INDUSTRY

  • Yang Fude

    lead OTHER

Principal Investigators

  • Yang Fude, director · Beijing HuiLongGuan Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-10-31
Primary Completion
2017-12-31
Completion
2017-12-31

Countries

  • China

Study Locations

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Diseases
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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02935998 on ClinicalTrials.gov