Trial Information

Summary: The Treatment of Adolescent Patients with Schizophrenia

This clinical research trial will study to see if aripiprazole, an investigational drug, is helpful for adolescents with schizophrenia and find out if the drug is safe for adolescents with schizophrenia.

Key Inclusion Criteria:

• Male or female patients, aged 13 to 17.
• Patients must have a DSM-IV diagnosis of schizophrenia with diagnosis confirmed by K-SADS-PL.
• PANSS score of greater than or equal to 70 at baseline (day 1).
• Both the parent and the patient's parent/legal representative must sign informed consent.
• Patient and parent/guardian must be able to comply with protocol requirements.

Key Exclusion Criteria:

• Patients currently diagnosed with schizoaffective disorder, major depressive disorder, delirium, or bipolar disorder.
• Patients who were hospitalized within 14 days prior to screening visit for current acute episode of schizophrenia.
• Patients with treatment-resistant schizophrenia.
• Female patients who are either pregnant or nursing.
• Patients with acute or unstable medical conditions.
• Patients clinically judged to be serious suicide risks.
• Patients previously unresponsive to, or currently being treated with, aripiprazole.
• Patients with substance or alcohol use disorder.
• Patients with mental retardation.
• Patients with any neurological disorder or condition other than ADHD and Tourette's Syndrome.

*please note that more specific inclusion/exclusion criteria must be met prior to entering the trial.

If you would like to learn more about participating in this study, please send an e-mail message using the form below.