Phase 3
N=67
Intramuscular (IM) Olanzapine Versus IM Haloperidol Plus Lorazepam for Acute Agitation in Schizophrenia
Schizophrenia · Schizoaffective Disorder · Agitation
Bottom Line
View on ClinicalTrials.gov: NCT00797277 ↗Enrolled (actual)
67
Serious AEs
0.0%
Results posted
Sep 2014
Primary outcome: Primary: The Change of the Positive and Negative Symptom Scale Excited Component (PANSS-EC) Score From Baseline to 120 Minutes After First Injection — -10.2; -9.9 units on a scale — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- IM olanzapine (Drug); IM haloperidol plus lorazepam (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- National Taiwan University Hospital
- Primary completion
- Jun 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Change of the Positive and Negative Symptom Scale Excited Component (PANSS-EC) Score From Baseline to 120 Minutes After First Injection |
-10.2; -9.9 | <0.05 sig |
| SECONDARY Change of the Agitation-Calmness Evaluation Scale (ACES) Score From Baseline to 120 Minutes After 1st Injection |
2.14; 2.23 | — |
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT00797277). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.