Status:
COMPLETED
Intramuscular (IM) Olanzapine Versus IM Haloperidol Plus Lorazepam for Acute Agitation in Schizophrenia
Lead Sponsor:
National Taiwan University Hospital
Collaborating Sponsors:
Yu-Li Hospital
Conditions:
Schizophrenia
Schizoaffective Disorder
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief 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 schizophreni...
Detailed Description
To date, there have been no published reports of clinical studies of IM olanzapine versus IM haloperidol plus lorazepam in acute schizophrenia patients with moderate to severe degree of agitation. The...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
67 Patients enrolled
Trial Details
Trial ID
NCT00797277
Start Date
July 1 2006
End Date
June 1 2009
Last Update
September 15 2014
Active Locations (1)
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1
Department of Psychiatry, National Taiwan University Hospital
Taipei, Taiwan, 100