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Trial record 18 of 23 for:    betadex

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

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ClinicalTrials.gov Identifier: NCT02935998
Recruitment Status : Unknown
Verified September 2016 by Yang Fude, Beijing HuiLongGuan Hospital.
Recruitment status was:  Not yet recruiting
First Posted : October 18, 2016
Last Update Posted : October 18, 2016
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Yang Fude, Beijing HuiLongGuan Hospital

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.

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: Ziprasidone Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multi-Center,Open-Labeled,Intervention Study:The Efficacy And Safety Of Intramuscular Ziprasidone For Three Days In Patients With Psychotic Agitation
Study Start Date : October 2016
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017


Arm Intervention/treatment
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.
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




Primary Outcome Measures :
  1. The change of BARS total scores [ Time Frame: 3 days after the first shot ]

Secondary Outcome Measures :
  1. The change of CGI-S scores [ Time Frame: 3 days after the first shot ]

Other Outcome Measures:
  1. The change of BARS/CGI-S/CGI-I scores from baseline to every visit [ Time Frame: 3 days after the first shot ]
  2. The percentage of response at the end of 2h(BARS decreased score>=2) [ Time Frame: 2 hours after the first shot ]
  3. The change of Simpson-Angus scores with from the baseline to endpoint [ Time Frame: 3 days after the first shot ]
  4. The incidence of ADR during the study in percent [ Time Frame: 3 days after the first shot ]
  5. The incidence of extrapyramidal symptoms during the study in percent [ Time Frame: 3 days after the first shot ]
  6. The incidence of tachycardia during the study in percent [ Time Frame: 3 days after the first shot ]
  7. The significance change rate of ECG and the average change of QT [ Time Frame: 3 days after the first shot ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02935998


Contacts
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Contact: Yang Fude, director +8613651336121 yangfd200@126.com
Contact: Zhang Qi, residents +8613051296767 407291579@qq.com

Locations
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China, Beijing
Beijing Huilongguan Hospital Not yet recruiting
Beijing, Beijing, China, 100096
Contact: Yang Fude, Director    +8613651336121    yangfd200@126.com   
Contact: Zhang Qi, Residents    +8613051296767    407291579@qq.com   
Sponsors and Collaborators
Yang Fude
Pfizer
Investigators
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Principal Investigator: Yang Fude, director Beijing HuiLongGuan Hospital

Publications of Results:
Other Publications:
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Responsible Party: Yang Fude, A Multi-Center,Open-Labeled,Intervention Study:The Efficacy And Safety Of Intramuscular Ziprasidone For Three Days In Patients With Psychotic Agitation, Beijing HuiLongGuan Hospital
ClinicalTrials.gov Identifier: NCT02935998     History of Changes
Other Study ID Numbers: QLXTJY-201649
First Posted: October 18, 2016    Key Record Dates
Last Update Posted: October 18, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Yang Fude, Beijing HuiLongGuan Hospital:
schizophrenia
agitation
ziprasidone
Additional relevant MeSH terms:
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Psychomotor Agitation
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Psychomotor Disorders
Neurobehavioral Manifestations
Signs and Symptoms
Ziprasidone
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents