Intramuscular (IM) Olanzapine Versus IM Haloperidol Plus Lorazepam for Acute Agitation in Schizophrenia

• Status: Completed
• Trial end date: 2009-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The aim of this study was to compare the efficacy and safety of intramuscular 10 mg olanzapine versus intramuscular 5 mg haloperidol plus lorazepam 2 mg in the treatment of acute agitated schizophrenic patients of Taiwanese populations.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Taiwan University Hospital
• Collaborator: Yu-Li Hospital
• Treatments: Haloperidol; Haloperidol decanoate; Lorazepam; Olanzapine

Criteria

Inclusion Criteria:

• Men and non-pregnant, non-lactating women aged 18 to 65 years with a primary diagnosis of schizophrenia (DSM-IV)

• were hospitalized due to an acute relapse

• were clinically agitated with a minimum total score of ≧ 14 on the five items of the PANSS-EC and at least one individual item score of ≧ 4 using the 1-7 scoring system prior to first IM injection of study drug.

Exclusion Criteria:

• female subjects who were either pregnant or breast-feeding;

• patients with acute, serious or unstable medical conditions;

• treatment with benzodiazepines within 4 hours prior to the first IM study drug administration;

• treatment with an injection depot neuroleptic within 1 injection interval prior to study drug administration;

• history of allergic reaction or intolerance to study medication(s);

• had a known diagnosis of dementia of any type, as defined in the DSM-IV.