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

NCT02935998 | Unknown Phase 4

• 1 other identifier: QLXTJY-201649
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

1. 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. 2.The primary objectiveis to evaluate the efficacy of intramuscular ziprasidone in patients with acute psychotic agitation in daily clinical practice.
3. 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. 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. 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

Schizophrenia

Keywords

schizophrenia; agitation; ziprasidone

Outcome Measures

Primary Outcomes (1)

• The change of BARS total scores

  3 days after the first shot

Secondary Outcomes (1)

• The change of CGI-S scores

  3 days after the first shot

Other Outcomes (7)

• The change of BARS/CGI-S/CGI-I scores from baseline to every visit

  3 days after the first shot

• The percentage of response at the end of 2h(BARS decreased score>=2)

  2 hours after the first shot

• The change of Simpson-Angus scores with from the baseline to endpoint

  3 days after the first shot

Study Arms (1)

ziprasidone

EXPERIMENTAL

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

Interventions

Ziprasidone DRUG

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.

Also known as: Injection mesylate ziprasidone

ziprasidone

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yang Fude: lead
• Pfizer: collaborator

Study Sites (1)

Beijing Huilongguan Hospital

Beijing, Beijing Municipality, 100096, China

Location

Related Publications (3)

• Marder SR. A review of agitation in mental illness: treatment guidelines and current therapies. J Clin Psychiatry. 2006;67 Suppl 10:13-21.

  PMID: 16965191 BACKGROUND

• 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.

  PMID: 23422376 RESULT

• Zimbroff DL, Allen MH, Battaglia J, Citrome L, Fishkind A, Francis A, Herr DL, Hughes D, Martel M, Preval H, Ross R. Best clinical practice with ziprasidone IM: update after 2 years of experience. CNS Spectr. 2005 Sep;10(9):1-15. doi: 10.1017/s1092852900025487.

  PMID: 16247923 RESULT

MeSH Terms

Conditions

Schizophrenia; Psychomotor Agitation

Interventions

ziprasidone

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Dyskinesias; Neurologic Manifestations; Nervous System Diseases; Psychomotor Disorders; Neurobehavioral Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Aberrant Motor Behavior in Dementia; Behavioral Symptoms; Behavior

Study Officials

• Yang Fude, director

  Beijing HuiLongGuan Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yang Fude, director

CONTACT

+8613651336121; yangfd200@126.com

Zhang Qi, residents

CONTACT

+8613051296767; 407291579@qq.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: A Multi-Center,Open-Labeled,Intervention Study:The Efficacy And Safety Of Intramuscular Ziprasidone For Three Days In Patients With Psychotic Agitation

Study Record Dates

• First Submitted: October 14, 2016
• First Posted: October 18, 2016
• Study Start: October 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: October 18, 2016

Record last verified: 2016-09

Locations

CN (1)