A Study of ALKS 3831 in Adults With Acute Exacerbation of Schizophrenia (the ENLIGHTEN-1 Study)

• Status: Completed
• Trial end date: 2017-06-07
• Target enrollment: 0
• Participant gender: All

Summary

This study will evaluate the efficacy of ALKS 3831 in adult subjects with acute exacerbation of schizophrenia.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alkermes, Inc.
• Treatments: Olanzapine

Criteria

Inclusion Criteria:

• Has a body mass index (BMI) of 18.0 - 40.0 kg/m^2

• Meets criteria for the diagnosis of schizophrenia

• Resides in a stable living situation when not hospitalized

• Is willing and able to provide government-issued identification

• Additional criteria may apply

Exclusion Criteria:

• Has had a psychiatric hospitalization for more than 30 days during the 90 days before screening

• Subject initiated first antipsychotic treatment within the past 12 months, or <1 year has elapsed since the initial onset of active-phase of schizophrenia symptoms

• Subject poses a current suicide risk

• Subject has a history of treatment resistance

• Subject has a history of poor or inadequate response to treatment with olanzapine

• Subject requires or has had electroconvulsive therapy (ECT) treatment in the 2-month period prior to screening

• Subject has a diagnosis of moderate or severe alcohol or drug use disorder

• Subject has a positive urine drug screen for opioids, amphetamine/methamphetamine, phencyclidine, or cocaine at screening

• Additional criteria may apply