Comparison of Intramuscular Olanzapine and Intramuscular Haloperidol in Patients With Schizophrenia
Status and phase
Completed
Phase 3
Conditions
Schizophrenia
Treatments
Drug: Olanzapine Hydrochloride
Drug: Haloperidol
Details and patient eligibility
About
The purpose of this study is to compare intramuscular Olanzapine and intramuscular Haloperidol in changing of agitation in patients with schizophrenia
Enrollment
50 patients
Sex
All
Ages
18 to 65 years old
Volunteers
No Healthy Volunteers
Inclusion criteria
- Male or female patients, between the ages of 18 and 65
- Patients must have diagnosis of schizophrenia that meets disease diagnostic criteria as defined in DSM-IV
- Patients must be considered, by the investigator, to be clinically agitated and appropriate candidates for treatment with IM medication. Investigator must believe that it is safe to administer IM olanzapine and IM comparator to the patients with respect to the safety profile of these drugs (including the anticholinergic properties of Olanzapine IM or the comparator agent)
- Subjects' illness must not, in the opinion of the investigator, be caused by substance abuse
- Patient must be hospitalized during the study
Exclusion criteria
- Previous participation (treatment with study drug) in a Lilly sponsored intra-muscular olanzapine clinical trial
- Serious, unstable illnesses such that death is anticipated within 1 year or intensive care unit hospitalization for the disease is anticipated within 6 months
- Have a known diagnosis of dementia of any type, as defined in the DSM-IV or DSM-IV-TR
- Documented history of allergic reaction to study medication(s)
- Treatment with an injectable depot neuroleptic within 1 injection interval prior to study drug administration
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
Double Blind
Trial contacts and locations
1
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Data sourced from clinicaltrials.gov
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