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Completed

NCT Number: NCT00723606

A Randomized, Open-Label, Multi-Center Study To Evaluate The Efficacy And Safety Of Intramuscular Ziprasidone In Patients With Agitation

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

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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Pfizer Investigational Site, Baoding, Hebei, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

Intramuscular ziprasidone mesylate

Drug

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.

Other names: Zeldox, Geodon

Intramuscular Haloperidol

Drug

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.

Other names: Haldol

Primary outcomes

  1. 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.

Secondary outcomes

  1. BPRS Agitation Subscale Response at 72 Hours

    Time frame: 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.

  2. Change From Baseline in BPRS Agitation Subscale Score at 72 Hours

    Time frame: Baseline, 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.

  3. Clinical Global Impression-Improvement (CGI-I) Score at 72 Hours

    Time frame: 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.

  4. Change From Baseline in Clinical Global Impressions Severity (CGI-S) Score at 72 Hours

    Time frame: Baseline, 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.

  5. Change From Baseline in Behavioral Activity Rating Scale (BARS) at 72 Hours

    Time frame: Baseline, 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.

Sponsors and collaborators

Lead sponsor

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Jul 29, 2008
Registry last updated
Mar 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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