Olanzapine Versus Placebo in the Treatment of Adolescents With Schizophrenia

Lilly

Status and phase

Completed

Phase 3

Conditions

Schizophrenia

Treatments

Drug: Olanzapine

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT00051298

4066

F1D-MC-HGIN

Details and patient eligibility

About

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.

Enrollment

107 patients

Sex

All

Ages

13 to 17 years old

Volunteers

No Healthy Volunteers

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.