Overview

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

Status:
Completed
Trial end date:
2018-11-07
Target enrollment:
0
Participant gender:
All
Summary
This study will evaluate weight gain of ALKS 3831 compared to olanzapine in adult subjects with schizophrenia.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Alkermes, Inc.
Treatments:
Olanzapine
Criteria
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 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