Schizophrenia
Conditions
Brief summary
This study is to determine the efficacy (how well the drug works), safety, and any side effects of olanzapine compared to placebo in the treatment of schizophrenia in adolescents. Both the potential benefits and side effects of olanzapine will be evaluated throughout this trial.
Interventions
DRUGOlanzapine
DRUGPlacebo
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
13 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* Are male or female patients, 13 to 17 years of age * Patients must have a diagnosis of schizophrenia per DSM-IV-TR. * Female patients of child-bearing potential must test negative for pregnancy at the time of enrollment. * Both the patient and the patient's parent/authorized legal representative must understand the nature of the study and must sign a document granting consent. * Patients must be capable of swallowing study medication whole (without crushing, dissolving, etc.)
Exclusion criteria
* Female patients who are either pregnant or nursing. * Patients with acute or unstable medical conditions. * Patients who have been judged clinically to be at serious suicidal risks. * Patients who have previously not responded to an adequate dose and/or duration of olanzapine treatment. * Patients who currently have delusional disorder, psychotic disorder NOS, schizophreniform, schizoaffective disorder, bipolar disorder, attention deficit/hyperactivity disorder or major depressive disorder.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assess the efficacy of a flexible dose of olanzapine compared to placebo in the treatment of adolescents (ages 13 - 17) with schizophrenia using the BPRS-C | — |
Secondary
| Measure | Time frame |
|---|---|
| Assess secondary efficacy measures to capture additional evidence of efficacy utilizing the CGI-I, CGI-S, PANSS and OAS | — |
| Assess the efficacy of olanzapine compared with placebo in improving clinical symptomatology in terms of rate of response | — |
| Assess the safety of olanzapine compared with placebo for up to 6 weeks of double-blind treatment and for up to an additional 26 weeks of open-label olanzapine treatment. | — |
| Assess the health-related quality of life and cognition associated with olanzapine compared with placebo for up to 6 weeks of double-blind treatment and for up to an additional 26 weeks of open-label olanzapine treatment. | — |
Countries
Russia, United States
Outcome results
None listed