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

NCT02935998

Last updated date
Study Location
Beijing Huilongguan Hospital
Beijing, Beijing, 100096, China
Contact
+8613651336121

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

By phone

Pfizer Clinical Trials Contact Center

+8613651336121

By email

Contact

[email protected]

Call Now

Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Schizophrenia
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-65 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

Subjects must meet the following criteria to be enrolled in the study:

- Male or female subjects aged 18-65 years

- Inpatients and outpatients who meet the diagnostic criteria for schizophrenia, schizoaffective disorder, Bipolar disorder with manic features or mixed features according to ICD-10

- BARS score >= 5 at baseline;

- Female subjects must have effective means of contraception (for example, oral prescription contraceptives, contraceptives, intrauterine device, a male partner sterilization, etc.) before screening phase and during the whole duration of study;

- Subjects can comply with the visit plan, treatment, laboratory examination and other research program;

- Subjects or their legal representatives understand the content of this research, agreed to participate in and sign a written informed consent and dated.

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Subjects who meet any of the following criteria will be excluded from the study:


- Have any major or unstable cardiovascular (especially arrhythmia), respiratory,
nervous system, including epilepsy or obvious cerebrovascular disease), kidney, liver,
endocrine, immune disease or related illness


- Have myocardial infarction or decompensated heart failure recently


- Confirmed clinically significant abnormal laboratory values


- Clinically significant ECG abnormality


- Subjects with a history of QTc prolongation or a pre-drug QTc of 450 msec or greater


- Subjects with serum K+ or Mg2+ out of the normal range


- A history of malignant syndrome or tardive dyskinesia history


- Concomitant use of drugs which may induce QTc prolongation during the study ,such as
Sotalol, quinidine, amiodarone, erythromycin, clozapine and clomipramine


- Known allergy to ziprasidone or any product ingredient


- Pregnant or lactating women or decide to pregnant in 3 month


- Use of antipsychotic agents within 12 hours or parenteral benzodiazepines within 4
hours prior to the baseline.

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

TRY A NEW SEARCH

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.

Based on your search, you may also be interested in

SchizophreniaAdd On Treatment for Cognitive Deficits in Schizophrenia
NCT01346163
  1. Philadelphia, Pennsylvania
ALL GENDERS
18 Years+
years
MULTIPLE SITES
SchizophreniaThe Efficacy And Safety Of Intramuscular Ziprasidone For Three Days In Patients With Psychotic Agitation
NCT02935998
  1. Beijing, Beijing
ALL GENDERS
18 Years+
years
MULTIPLE SITES
SchizophreniaZiprasidone for Clozapine- or Olanzapine-Associated Diabetes Mellitus
NCT00351000
  1. Boston, Massachusetts
ALL GENDERS
18 Years+
years
MULTIPLE SITES
SchizophreniaEffects of Varenicline on Plasticity in Schizophrenia
NCT01934023
  1. Toronto, Ontario
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE The Efficacy And Safety Of Intramuscular Ziprasidone For Three Days In Patients With Psychotic Agitation
Official Title  ICMJE A Multi-Center,Open-Labeled,Intervention Study:The Efficacy And Safety Of Intramuscular Ziprasidone For Three Days In Patients With Psychotic Agitation
Brief 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.
Detailed Description
  1. Trial Design:This is a multi-center, open-labeled, intervention study.
  2. STUDY EVALUATION?1)Primary efficacy endpoint?The change of BARS total scores from baseline to the endpoint.2)Secondary efficacy endpoint?

    • The change of CGI-S from baseline to the endpoint
    • The change of BARS/CGI-S/CGI-I from baseline to every visit
    • The percentage of response at the end of 2h(BARS decreased score>=2)
    • Subgroup analysis:(1)Comparison of the difference of the reduction in BARS/CGI-S in the different diseases subgroup.(2)Comparison of the difference of the reduction in BARS/CGI-S in the first episode and multi-episode patients.(3)Comparison of the difference of the reduction in BARS/CGI-S in the different previous antipsychotic treatment.(4)Comparison of the difference of disease categories, dosage, duration, and the reduction in BARS/CGI-S in the monotherapy and combination with other oral antipsychotic drugs Safety evaluation 3)Include adverse events, ECG(the change rate of ECG and the average change of QT),vital signs from the baseline to the endpoint.

      1. The change of Simpson-Angus with from the baseline to endpoint.
      2. The incidence of ADR?extrapyramidal symptoms?tachycardia during the studyThe incidence of during the study.
  3. STUDY DRUGS:The injection mesylate ziprasidone used in this study have been marketed, manufactured by Pfizer and provided study drug for research purposes.Strength:Each vial contains Ziprasidone 30 mg, Sulfobutyl betadex sodium 441 mg. When reconstituted as directed the solution for injection contains the equivalent of 20 mg per mL of Ziprasidone.Ziprasidone intramuscular is intended for intramuscular use only and should not be administered intravenously.
  4. DATA ADMINISTRATION AND STATISTICAL METHODS:The case report form (CRF) used in this clinical study is in paper form.

    The data and statistical analysis collected in study will be recorded in the statistical analysis program (SAP).

  5. Basic principles of research design:Collecting the safety, effectiveness indexes in the process of drug treatment, analysis the changes before and after 3 days of the treatment, and record injection in the process of the study, in order to analyze the safety and efficacy of injection ziprasidone in the real clinical practice.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Schizophrenia
Intervention  ICMJE 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.
Other Name: Injection mesylate ziprasidone
Study Arms  ICMJE Experimental: ziprasidone
The injection mesylate ziprasidone used in this study have been marketed, manufactured by Pfizer and provided study drug for research purposes.Strength:Each vial contains Ziprasidone 30 mg, Sulfobutyl betadex sodium 441 mg. When reconstituted as directed the solution for injection contains the equivalent of 20 mg per mL of Ziprasidone.The initial dosage of ziprasidone injection?Most patients are suggested with 20mg i.m. Those with first-episode, lower age, emaciated body, or BARS score at 5 are suggest with 10mg i.m. 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.
Intervention: Drug: Ziprasidone
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: October 14, 2016)
1000
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2017
Estimated Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

Subjects must meet the following criteria to be enrolled in the study:

  • Male or female subjects aged 18-65 years
  • Inpatients and outpatients who meet the diagnostic criteria for schizophrenia, schizoaffective disorder, Bipolar disorder with manic features or mixed features according to ICD-10
  • BARS score >= 5 at baseline?
  • Female subjects must have effective means of contraception (for example, oral prescription contraceptives, contraceptives, intrauterine device, a male partner sterilization, etc.) before screening phase and during the whole duration of study;
  • Subjects can comply with the visit plan, treatment, laboratory examination and other research program;
  • Subjects or their legal representatives understand the content of this research, agreed to participate in and sign a written informed consent and dated.

Exclusion Criteria:

  • Subjects who meet any of the following criteria will be excluded from the study:
  • Have any major or unstable cardiovascular (especially arrhythmia), respiratory, nervous system, including epilepsy or obvious cerebrovascular disease), kidney, liver, endocrine, immune disease or related illness
  • Have myocardial infarction or decompensated heart failure recently
  • Confirmed clinically significant abnormal laboratory values
  • Clinically significant ECG abnormality
  • Subjects with a history of QTc prolongation or a pre-drug QTc of 450 msec or greater
  • Subjects with serum K+ or Mg2+ out of the normal range
  • A history of malignant syndrome or tardive dyskinesia history
  • Concomitant use of drugs which may induce QTc prolongation during the study ,such as Sotalol, quinidine, amiodarone, erythromycin, clozapine and clomipramine
  • Known allergy to ziprasidone or any product ingredient
  • Pregnant or lactating women or decide to pregnant in 3 month
  • Use of antipsychotic agents within 12 hours or parenteral benzodiazepines within 4 hours prior to the baseline.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02935998
Other Study ID Numbers  ICMJE QLXTJY-201649
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD:Undecided
Responsible Party Yang Fude, Beijing HuiLongGuan Hospital
Study Sponsor  ICMJE Yang Fude
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator:Yang Fude, directorBeijing HuiLongGuan Hospital
PRS Account Beijing HuiLongGuan Hospital
Verification Date September 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP