A Study Comparing Rapid Acting Intramuscular Olanzapine and Placebo in Agitated Patients With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: Rapid Acting Intramuscular Olanzapine; Isotonic sodium chloride solution
Intervention description: 10mg/injection, IM. If patients do not respond to the first study medication or if patients do not have enough improvement based on the investigator's judgment, and in addition, if the investigator judges it is reasonable, the patient will receive a second injection at the same dose strength as the first injection after 2 hours following the first injection (no later than 8 hours after the first injection).; 0.9% sodium chloride (NaCl) solution. If patients do not respond to the first study medication or if patients do not have enough improvement based on the investigator's judgment, and in addition, if the investigator judges it is reasonable, the patient will receive a second injection at the same dose strength as the first injection after 2 hours following the first injection (no later than 8 hours after the first injection).
Intervention MeSH terms: Olanzapine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 34.0
Sex: All
Minimum age: 20 Years
Maximum age: 64 Years
Healthy volunteers: No

Summary:

      The primary objectives of the study is to confirm if the efficacy of IM olanzapine in
      patients with schizophrenia is greater than IM placebo by comparing changes from baseline to
      2 hours post first IM injection of agitation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients have met Diagnostic and Statistical Manual of Mental Disorders Fourth
             Edition, Text Revision (DSM-IV-TR) criteria for schizophrenia.

          -  Male or female, at least 20 years and less than 65 years old.

          -  Inpatients during the study.

          -  Each patient, or a proxy consenter, understand the nature of the study and must sign
             an informed consent document. The patient is able to cooperate with all study
             procedures in the view of the investigator.

          -  Patients are considered, by the investigator or subinvestigator, to be clinically
             agitated and appropriate candidates for treatment with intramuscular (IM) medication.
             The investigator must believe that it is safe to administer IM olanzapine to the
             patients with respect to the safety profile, including the anticholinergic properties
             of Olanzapine IM.

          -  Patients have a minimum total score of ≧ 20 on the five items of the Positive and
             Negative Syndrome Scale-Excited Component (PANSS-EC) using the 1-7 scoring system
             prior to the first injection of study drug.

          -  Patients have a score of 1 or 2 on the Agitation-Calmness Evaluation Scale (ACES)
             prior to the first injection of study drug.

        Exclusion Criteria:

          -  Patients who were previously treated with oral olanzapine and are considered to be
             treatment-resistant to oral olanzapine, in the opinion of the investigator.

          -  Patients who have a history of allergic reaction or intolerance to study medication.

          -  Patients who show evidence of clinically significant bradycardia or arrhythmia
             obtained either from a physical exam or an electrocardiogram (ECG).

          -  Patients who require concomitant treatment with any other medication with primary
             central nervous system activity, other than those allowed as specified in section
             "concomitant treatment".

          -  Patients who have acute, serious or unstable medical conditions, including (but not
             limited to) hepatic insufficiency (specifically any degree of jaundice), recent
             cerebrovascular accidents, uncontrolled seizure disorders, serious acute systemic
             infection or immunologic disease, unstable cardiovascular disorders (including
             ischemic heart disease), renal, gastroenterologic, respiratory, endocrinologic,
             neurologic, or hematologic diseases.

          -  Patients with inadequately controlled diabetes, or patients whose treatment for
             diabetes were changed within 4 weeks prior to the first injection of the study drug.
             The investigator's discretion will supersede even if the patients do not meet the
             above criteria for concurrent diabetes.

          -  Patients who have a known neutrophil count or total of segmented cell and band cell
             counts of <1,500 /millimeter cubed (mm3).

          -  Patients who have a known alanine aminotransferase/serum glutamic pyruvic transaminase
             (ALT/SGPT) values ≧2 times the normal upper limit of the performing laboratory (ULN)
             or aspartate aminotransferase/serum glutamic oxaloacetic transaminase (AST/SGOT)
             values ≧3 times the ULN or total bilirubin values ≧1.5 times the ULN.

          -  Patients who have a known serum triglycerides ≧500 milligrams/deciliter (mg/dL).

          -  Electrocardiogram abnormalities considered clinically significant by the investigator.

          -  Patients who have had treatment with injectable depot antipsychotics within one
             injection interval prior to study drug administration.

          -  Patients who have received treatment with antipsychotics or other prohibited
             concomitant medicines showing in the section "prohibited concomitant medicines" within
             2 hours prior to the first IM study drug administration.

          -  Patients who have had treatment with benzodiazepines within 4 hours prior to first IM
             study drug administration.

          -  Patients who have been administered epinephrine within 24 hours prior to the first IM
             study drug administration.

          -  Patients who have received treatment with psychostimulants or reserpine within 7 days
             prior to the first IM study drug administration.

          -  Patients who have received beta blockers or calcium channel blockers previously, must
             have been taking the same medication at the same dose for 28 days prior to the first
             IM study drug administration. No beta blockers or calcium channel blockers may be
             administered within 24 hours of the first IM study drug injection, or any time during
             the double blind phase.