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Completed

NCT Number: NCT00485810

Examining Rapid Acting Intra-Muscular Olanzapine in Japanese Patients With Schizophrenia

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

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Key information

Age range

20 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

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.

Sapporo, Japan

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Olanzapine Hydrochloride

Drug

Primary outcomes

  1. 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

  1. 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

  2. To examine the characteristics of sedation for each treatment group based on the ACES score

  3. To examine a frequency of patients who needed second injection

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

A Study Examining Clinical Therapeutic Dose of Rapid Acting Intra-Muscular Olanzapine in Japanese Agitated Patients With Schizophrenia

Important dates

Study start
2004
Study completion
2004
First posted
Jun 13, 2007
Registry last updated
Jun 13, 2007

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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