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

Alkermes

Status and phase: Completed; Phase 3

Conditions: Schizophrenia

Treatments: Drug: Olanzapine; Drug: Placebo; Drug: ALK3831

Study type: Interventional

Funder types: Industry

Identifiers

NCT02634346

ALKS-3831-A305

Details and patient eligibility

About

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

Enrollment: 403 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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403 participants in 3 patient groups, including a placebo group

ALKS 3831

Experimental group

Description:

Administered as a coated bilayer tablet

Treatment:

Drug: ALK3831

Olanzapine

Active Comparator group

Description:

Administered as a coated bilayer tablet

Treatment:

Drug: Olanzapine

Placebo

Placebo Comparator group

Description:

Administered as a coated bilayer tablet

Treatment:

Drug: Placebo