Schizophrenia
Conditions
Brief summary
Key objectives of this clinical study are to: * Determine how well intramuscular (IM) olanzapine depot works compared to placebo * Evaluate the safety and tolerability of IM olanzapine depot compared to placebo * Evaluate different doses of IM olanzapine depot compared to placebo to identify the best dose(s).
Interventions
DRUGPlacebo
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Patients must have schizophrenia and be experiencing a psychotic episode * Each patient must have a level of understanding sufficient to complete all tests and examinations required by the protocol, and to provide informed consent * Patient must not have participated in a clinical trial of another investigational drug, including olanzapine, within 1 month (30 days) prior to the study entry * Female patients must not be pregnant or breast-feeding * Female patients must not be experiencing acute, serious or unstable medical conditions other than schizophrenia
Exclusion criteria
* Patients who were previously treated with olanzapine and are considered to be treatment-resistant to olanzapine, in the opinion of the investigator * One or more seizures without a clear and resolved etiology is exclusionary. However, if the patient has had one or more seizures in the past with an identifiable etiology, and that etiology has been resolved, the patient may be entered. * Treatment with clozapine within 4 weeks prior to visit 1 * DSM-IV or DSM-IV-TR substance (except nicotine and caffeine) dependence within the past 30 days * Treatment with remoxipride within 6 months (180 days) prior to visit 1
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Demonstrate superiority of IM olanzapine depot 300 mg/2 weeks, 405 mg/4 weeks, and 210 mg/2 weeks dosages compared with placebo in the treatment of patients with schizophrenia | — |
Secondary
| Measure | Time frame |
|---|---|
| To determine the earliest time point at which 300 mg/2 weeks, 405 mg/4 weeks, and 210 mg/2 weeks IM olanzapine depot show superior clinical improvement compared with placebo | — |
| To assess the efficacy of 300 mg/2 weeks, 405 mg/4 weeks, and 210 mg/2 weeks IM olanzapine depot compared with placebo in CGI-S | — |
| To assess the efficacy of 300 mg/2 weeks, 405 mg/4 weeks, and 210 mg/2 weeks IM olanzapine depot compared with placebo in terms of change in PANSS Positive, PANSS Negative and PANSS General Psychopathology subscales | — |
| To assess the efficacy of 300 mg/2 weeks, 405 mg/4 weeks, and 210 mg/2 weeks IM olanzapine depot compared with placebo in CGI-I | — |
| To evaluate the safety and tolerability of 300 mg/2 weeks, 405 mg/4 weeks, and 210 mg/2 weeks IM olanzapine depot compared with placebo | — |
| To characterize the pharmacokinetics of olanzapine following multiple dosing with IM olanzapine depot at each of the prescribed dosing regimens | — |
| To assess the efficacy of 300 mg/2 weeks, 405 mg/4 weeks, and 210 mg/2 weeks IM olanzapine depot compared with placebo in change from baseline to endpoint in quality of life | — |
Countries
Croatia, Russia, United States
Outcome results
None listed