Clinical trial NCT00485901: Comparison of Intramuscular Olanzapine and Intramuscular Haloperidol in Patients With Schizophrenia
Official title: A Double-Blind Randomized Comparison of the Efficacy and Safety of Intramuscular Olanzapine and Intramuscular Haloperidol in Acutely Agitated Patients With Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Schizophrenia
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2007-06-13
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare intramuscular Olanzapine and intramuscular Haloperidol in changing of agitation in patients with schizophrenia


Eligibility criteria: 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

Primary outcomes:
measure: Assess the efficacy of IM olanzapine compared with IM haloperidol in changing of agitation from baseline to 2 hours post-first IM injection
Secondary outcomes:
measure: Assess treatment-emergent adverse events, change in vital signs and extrapyramidal symptoms of IM olanzapine versus IM haloperidol during the study
measure: Assess the efficacy of IM olanzapine compared with IM haloperidol from baseline to 15 min, 30 min, 60 min and 120 minutes post-first IM injection
measure: Compare the response rates and time to response during the 2 hours post-first IM injection.
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References: