A Phase 4 interventional study of Olanzapine and Aripiprazole in Schizophrenia, sponsored by Eli Lilly and Company. Completed at 5 sites in 2 countries. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2007-11-06.
Sponsored by Eli Lilly and Company · Phase 4, Interventional, and Treatment
The purposes of this study are to assess similarities and differences in the efficacy (how well the drug works), safety, and side effects of olanzapine and aripiprazole in patients with schizophrenia, schizoaffective disorder, or schizophreniform disorder.
3,470 studies on the registry are indexed under Schizophrenia; 471 are open to participants now.
This study's enrollment of 600 is above the median of 70 across 2,871 interventional studies indexed under Schizophrenia.
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Of its 521 completed or terminated interventional studies of FDA-regulated products, 341 (65%) have results posted.
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The primary objective of this study is to test the hypothesis that olanzapine is superior to aripiprazole in the reduction of symptoms of agitation in acutely ill patients with schizophrenia, as measured by mean change in the
Positive and Negative Syndrome Scale Excited Component (PANSS-EC) over 5 days of treatment (4 continuous 24 hr treatment exposures). The null hypothesis of the study is that there is no difference between olanzapine and
aripiprazole in reducing agitation.
The reduction in positive symptoms as measured by the Brief Psychiatric Rating Scale Positive subscale (PBRS Positive);
The reduction of symptoms of agitation as measured by Overt Agitation Severity Scale (OASS);
The proportion of patients responding to treatment and the time to response based on varying levels in the percent reduction of
the PANSS_EC from baseline;
The reduction in overall severity of psychiatric illness as measured by the Clinical Global Impression-Severity Scale (CGI-S);
The intensity of nursing intervention (e.g. seclusion, restraint, special nursing watch), as measured by the Global Assessment
of Nursing Intervention
The proportion of patients using pm lorazepam and the time-course of usage.
The proportion of patients discontinuing from the study due to lack of efficacy or due to adverse events related to worsening
of psychiatric illness.
Patient satisfaction with their medication, as measured by Drug Attitude Inventory (DA1-10).
A sensitivity analysis will be performed on two randomly chosen subsamples of the overall patient population by analyzing the
primary objective respectively.
Additional secondary objectives of the study are to compare the safety of olanzapine versus aripiprazole over the course of 5
days in the treatment of acutely ill patients with schizophrenia as assessed by:
Relative degree of sedation as measured by the Agitation Calmness Evalution Scale (ACES);
Review of spontaneous (unsolicited) treatment emergent adverse events;
Development of extrapyramidal symptoms as assessed by daily Modified Simpson-Angus and Barnes Akathisia scale scores.
This study is completed, as verified in Nov 2007. You cannot join it, but the record below documents what was studied.
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