A Study of ALKS 3831 in Adults With Schizophrenia (The ENLIGHTEN-2 Study)

Alkermes

Status and phase: Completed; Phase 3

Conditions: Schizophrenia

Treatments: Drug: Olanzapine; Drug: ALKS 3831

Study type: Interventional

Funder types: Industry

Identifiers

NCT02694328

ALK3831-A303

Details and patient eligibility

About

This study will evaluate weight gain of ALKS 3831 compared to olanzapine in adult subjects with schizophrenia.

Enrollment: 561 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subject has a body mass index (BMI) of 18.0-30.0 kg/m^2, inclusive, at Visit 1 and Visit 2
• Subject meets the DSM-5 criteria for a primary diagnosis of schizophrenia
• Subject is appropriate for outpatient treatment; has no hospitalizations for acute exacerbations of schizophrenia within 6 months before Visit 1
• Subject has maintained a stable body weight (change </= 5%) for at least 3 months prior to Visit 1 based on self-report
• Additional criteria may apply

Exclusion criteria

• Subject has any of the following psychiatric conditions per DSM-5 criteria:
• Diagnosis of schizoaffective disorder or bipolar I or II disorder, or current, untreated or unstable major depressive disorder
• Clinically significant cognitive difficulties present within the past 2 years that could interfere with participation in the study
• Drug-induced or toxic psychosis
• Any other psychiatric condition that could interfere with participation in the study
• Subject poses a current suicide risk at Visit 1 or Visit 2 in the opinion of the investigator
• Subject has inflammatory bowel disease or any other gastrointestinal disorder associated with weight loss, anorexia nervosa, or binge eating disorder
• Additional criteria may apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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561 participants in 2 patient groups

ALKS 3831

Experimental group

Description:

Administered as a coated bilayer tablet

Treatment:

Drug: ALKS 3831

Olanzapine

Active Comparator group

Description:

Administered as a coated bilayer tablet

Treatment:

Drug: Olanzapine