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

January 29, 2020 updated by: Alkermes, Inc.

A Phase 3 Study to Evaluate Weight Gain of ALKS 3831 Compared to Olanzapine in Adults With Schizophrenia

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

561

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • San Juan, Puerto Rico, 00918
        • Alkermes Investigational Site
      • San Juan, Puerto Rico, 00926
        • Alkermes Investigational Site
    • Arkansas
      • Little Rock, Arkansas, United States, 72211
        • Alkermes Investigational Site
      • Springdale, Arkansas, United States, 72764
        • Alkermes Investigational Site
    • California
      • Anaheim, California, United States, 92805
        • Alkermes Investigational Site
      • Cerritos, California, United States, 90703
        • Alkermes Investigational Site
      • Culver City, California, United States, 90230
        • Alkermes Investigational Site
      • Garden Grove, California, United States, 92845
        • Alkermes Investigational Site
      • Glendale, California, United States, 91206
        • Alkermes Investigational Site
      • Long Beach, California, United States, 90822
        • Alkermes Investigational Site
      • National City, California, United States, 91950
        • Alkermes Investigational Site
      • Oakland, California, United States, 94612
        • Alkermes Investigational Site
      • Oceanside, California, United States, 92056
        • Alkermes Investigational Site
      • Orange, California, United States, 92868
        • Alkermes Investigational Site
      • Pico Rivera, California, United States, 90660
        • Alkermes Investigational Site
      • Redlands, California, United States, 92374
        • Alkermes Investigational Site
      • San Diego, California, United States, 92123
        • Alkermes Investigational Site
      • San Diego, California, United States, 92103
        • Alkermes Investigational Site
      • Temecula, California, United States, 92591
        • Alkermes Investigational Site
      • Torrance, California, United States, 90502
        • Alkermes Investigational Site
    • District of Columbia
      • Washington, District of Columbia, United States, 20016
        • Alkermes Investigational Site
    • Florida
      • Lauderhill, Florida, United States, 33319
        • Alkermes Investigational Site
      • Miami, Florida, United States, 33136
        • Alkermes Investigational Site
      • North Miami, Florida, United States, 33161
        • Alkermes Investigational Site
      • Oakland Park, Florida, United States, 33334
        • Alkermes Investigational Site
      • Tampa, Florida, United States, 33609
        • Alkermes Investigational Site
    • Georgia
      • Atlanta, Georgia, United States, 30329
        • Alkermes Investigational Site
      • Augusta, Georgia, United States, 30912
        • Alkermes Investigational Site
      • Decatur, Georgia, United States, 30030
        • Alkermes Investigational Site
    • Illinois
      • Chicago, Illinois, United States, 60640
        • Alkermes Investigational Site
    • Michigan
      • Grand Rapids, Michigan, United States, 49503
        • Alkermes Investigational Site
    • Mississippi
      • Flowood, Mississippi, United States, 39232
        • Alkermes Investigational Site
    • Missouri
      • Creve Coeur, Missouri, United States, 63141
        • Alkermes Investigational Site
      • O'Fallon, Missouri, United States, 63368
        • Alkermes Investigational Site
      • Saint Louis, Missouri, United States, 63128
        • Alkermes Investigational Site
    • Nevada
      • Las Vegas, Nevada, United States, 89102
        • Alkermes Investigational Site
    • New Jersey
      • Berlin, New Jersey, United States, 08009
        • Alkermes Investigational Site
      • Marlton, New Jersey, United States, 08053
        • Alkermes Investigational Site
    • New York
      • Brooklyn, New York, United States, 11235
        • Alkermes Investigational Site
      • Jamaica, New York, United States, 11432
        • Alkermes Investigational Site
      • New York, New York, United States, 10032
        • Alkermes Investigational Site
      • New York, New York, United States, 10035
        • Alkermes Investigational Site
      • Rochester, New York, United States, 14615
        • Alkermes Investigational Site
      • Wards Island, New York, United States, 10035
        • Alkermes Investigational Site
    • Ohio
      • Canton, Ohio, United States, 44718
        • Alkermes Investigational Site
      • Dayton, Ohio, United States, 45417
        • Alkermes Investigational Site
      • Middleburg Heights, Ohio, United States, 44130
        • Alkermes Investigational Site
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18104
        • Alkermes Investigational Site
    • Texas
      • Austin, Texas, United States, 78754
        • Alkermes Investigational Site
      • Austin, Texas, United States, 78759
        • Alkermes Investigational Site
      • Dallas, Texas, United States, 75243
        • Alkermes Investigational Site
      • DeSoto, Texas, United States, 75115
        • Alkermes Investigational Site
      • Houston, Texas, United States, 77030
        • Alkermes Investigational Site
    • Washington
      • Bellevue, Washington, United States, 98007
        • Alkermes Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ALKS 3831
Administered as a coated bilayer tablet
Daily dosing
Active Comparator: Olanzapine
Administered as a coated bilayer tablet
Daily dosing

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percent Change From Baseline in Body Weight at Week 24
Time Frame: Baseline and Week 24
Baseline and Week 24
Percentage of Participants With >/= 10% Weight Gain at Week 24
Time Frame: Baseline and Week 24
Baseline and Week 24

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 2, 2016

Primary Completion (Actual)

November 7, 2018

Study Completion (Actual)

November 7, 2018

Study Registration Dates

First Submitted

February 24, 2016

First Submitted That Met QC Criteria

February 24, 2016

First Posted (Estimate)

February 29, 2016

Study Record Updates

Last Update Posted (Actual)

February 10, 2020

Last Update Submitted That Met QC Criteria

January 29, 2020

Last Verified

January 1, 2020

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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