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

Phase 3

Completed

• Conditions: Schizophrenia
• Interventions: Drug: ALKS 3831; Drug: Olanzapine

• Registration Number: NCT02694328
• Lead Sponsor: Alkermes, Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-02-24
• Study First Submitted QC: 2016-02-24
• Study First Posted: 2016-02-29
• Study Start: 2016-03-02
• Primary Completion: 2018-11-07
• Study Completion: 2018-11-07
• Results First Submitted: 2019-11-07
• Status Verified: 2020-01
• Results First Submitted QC: 2020-01-29
• Last Update Submitted: 2020-01-29
• Results First Posted: 2020-02-10
• Last Update Posted: 2020-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 561

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ALKS 3831	ALKS 3831	Administered as a coated bilayer tablet
Olanzapine	Olanzapine	Administered as a coated bilayer tablet

Primary Outcome Measures

Name	Time	Method
Percent Change From Baseline in Body Weight at Week 24	Baseline and Week 24
Percentage of Participants With >/= 10% Weight Gain at Week 24	Baseline and Week 24

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With >/= 7% Weight Gain at Week 24	Baseline and Week 24
Number of Participants Experiencing of Adverse Events (AEs)	24 weeks

Trial Locations

Locations (1)

Alkermes Investigational Site; 🇵🇷 San Juan, Puerto Rico