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

Schizophrenia research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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.

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Schizophrenia

Schizoaffective Disorder

Agitation

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:IM olanzapine10mg olanzapine IM

Drug:IM haloperidol plus lorazepamIM 5 mg haloperidol plus IM 2 mg lorazepam

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

IM olanzapinePatients of this arm received 10 mg IM olanzapine after randomization

IM haloperidol plus lorazepamPatients of this arm received 5 mg IM haloperidol plus 2 mg IM lorazepam after randomization

Study Status

Completed

Start Date: July 2006

Completed Date: June 2009

Phase: Phase 3

Type: Interventional

Design:

Primary Outcome: The Change of the Positive and Negative Symptom Scale Excited Component (PANSS-EC) Score From Baseline to 120 Minutes After First Injection

Secondary Outcome: Change of the Agitation-Calmness Evaluation Scale (ACES) Score From Baseline to 120 Minutes After 1st Injection

Study sponsors, principal investigator, and references

Principal Investigator: Tzung-Jeng Hwang, MD, MPH, PhD

Lead Sponsor: National Taiwan University Hospital

Collaborator: Yu-Li Hospital

More information:https://clinicaltrials.gov/show/NCT00797277

Breier A, Meehan K, Birkett M, David S, Ferchland I, Sutton V, Taylor CC, Palmer R, Dossenbach M, Kiesler G, Brook S, Wright P. A double-blind, placebo-controlled dose-response comparison of intramuscular olanzapine and haloperidol in the treatment of acute agitation in schizophrenia. Arch Gen Psychiatry. 2002 May;59(5):441-8.

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