Clinical trial NCT00485810: Examining Rapid Acting Intra-Muscular Olanzapine in Japanese Patients With Schizophrenia
Official title: A Study Examining Clinical Therapeutic Dose of Rapid Acting Intra-Muscular Olanzapine in Japanese Agitated Patients With Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Schizophrenia
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2007-06-13
Enrollment: 31
Sex: ALL
Minimum age (years): 20
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to examine the clinical therapeutic dose in Japanese agitated patients with schizophrenia.


Eligibility criteria: Inclusion Criteria:

* Male or female patients at least 20 years of age and less than 65 years old
* Patients must be inpatients during the study
* Patients must have a diagnosis of schizophrenia as per the DSM-IV, as determined by the investigator
* Patients must be considered by the investigator to be clinically agitated and to be clinically appropriate candidates for the treatment with intramuscular (IM) medication
* Patients must have a minimum total score of greater than or equal to 14 on the 5 items of the PANSS-EC and at least one individual item score of greater than or equal to 4 using the 1-7 scoring system, prior to the first IM injection of study drug

Exclusion Criteria:

* Serious, unstable illnesses such that death is anticipated within 1 year or intensive care unit hospitalization for the disease is anticipated within 6 months. This includes hepatic (specifically any degree of jaundice), renal, gastroenterologic, respiratory, cardiovascular (including ischemic heart disease), endocrinologic, neurologic, immunologic, or hematologic diseases
* Known history of seizures; however, a patient whose etiology is identifiable and has been resolved may be enrolled
* Known history of diabetes mellitus, complications of diabetes mellitus, or potential diabetes mellitus as defined by patients with single blood glucose measurement based on site tests; patients with values greater than or equal to 140 mg/dL (non-fasting) or greater than or equal to 110 mg/dL (fasting) must be excluded from the study
* History of allergic reaction or intolerance to olanzapine
* Have received treatment with psychostimulants or reserpine within 1 week prior to study drug administration

Primary outcomes:
measure: The primary objective is to examine the safety and efficacy of the clinical therapeutic dose of IM olanzapine (7.5 mg/inj and 10 mg/inj) in Japanese agitated patients with schizophrenia
Secondary outcomes:
measure: To examine the efficacy of IM olanzapine by evaluating change from baseline to 24 hours following the first IM injection in the PANSS Excited Component Total Score and the ACES
measure: To examine the characteristics of sedation for each treatment group based on the ACES score
measure: To examine a frequency of patients who needed second injection
Other outcomes:
Locations:
city: Sapporo
country: Japan
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References: