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

Completed · Phase 3 · Has a placebo group

Conditions studied: Schizophrenia

In brief

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

Key facts

Study ID

NCT02634346

Run by

Alkermes, Inc.

People needed

403

Starts

2015-12-01

Expected to finish

2017-06-07

Last updated by the study team

2018-06-27

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Alkermes Investigational Site — Little Rock, Arkansas, United States
• Alkermes Investigational Site — Springdale, Arkansas, United States
• Alkermes Investigational Site — Culver City, California, United States
• Alkermes Investigational Site — Garden Grove, California, United States
• Alkermes Investigational Site — Lemon Grove, California, United States
• Alkermes Investigational Site — Long Beach, California, United States
• Alkermes Investigational Site — Orange, California, United States
• Alkermes Investigational Site — San Diego, California, United States
• Alkermes Investigational Site — Washington D.C., District of Columbia, United States
• Alkermes Investigational Site — North Miami, Florida, United States
• Alkermes Investigational Site — Chicago, Illinois, United States
• Alkermes Investigational Site — St Louis, Missouri, United States
• Alkermes Investigational Site — Las Vegas, Nevada, United States
• Alkermes Investigational Site — Marlton, New Jersey, United States
• Alkermes Investigational Site — Dayton, Ohio, United States
• Alkermes Investigational Site — Dallas, Texas, United States
• Alkermes Investigational Site — Burgas, Bulgaria
• Alkermes Investigational Site — Kazanlak, Bulgaria
• Alkermes Investigational Site — Lovech, Bulgaria
• Alkermes Investigational Site — Novi Iskar, Bulgaria
• Alkermes Investigational Site — Plovdiv, Bulgaria
• Alkermes Investigational Site — Veliko Tarnovo, Bulgaria
• Alkermes Investigational Site — Vratsa, Bulgaria
• Alkermes Investigational Site — Belgrade, Serbia
• Alkermes Investigational Site — Kragujevac, Serbia

Full record on ClinicalTrials.gov

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