Study to Evaluate the Efficacy of ALKS 3831 on Body Weight in Young Adults Who Have Been Recently Diagnosed With Schizophrenia, Schizophreniform, or Bipolar I Disorder

A Study to Evaluate the Effect of ALKS 3831 Compared to Olanzapine on Body Weight in Young Adults With Schizophrenia, Schizophreniform, or Bipolar I Disorder Who Are Early in Their Illness

This study will evaluate the effect of ALKS 3831 compared to olanzapine on body weight in young adults with schizophrenia, schizophreniform, or bipolar I disorder who are early in their illness

Study Overview

• Status: Completed
• Conditions: Schizophrenia; Bipolar I Disorder; Schizophreniform Disorders
• Intervention / Treatment: Drug: ALKS 3831; Drug: Olanzapine

Detailed Description

In the US adolescent subjects starting at age 16 will be enrolled. In the EU, subjects age 18 and older will be enrolled.

• Study Type: Interventional
• Enrollment (Actual): 426
• Phase: Phase 3

Contacts and Locations

Study Locations

• Austria
  • Vienna, Austria
    • Alkermes Investigational Site
• Germany
  • Muenchen, Germany
    • Alkermes Investigational Site
• Ireland
  • Galway, Ireland
    • Alkermes Investigational Site
• Israel
  • Jerusalem, Israel
    • Alkermes Investigational Site
  • Tel HaShomer, Israel
    • Alkermes Investigational Site
• Italy
  • Brescia, Italy
    • Alkermes Investigational Site
  • Naples, Italy
    • Alkermes Investigational Site
  • Torino, Italy
    • Alkermes Investigational Site
• Korea, Republic of
  • Busan, Korea, Republic of
    • Alkermes Investigational Site
  • Daegu, Korea, Republic of
    • Alkermes Investigational Site
  • Naju, Korea, Republic of
    • Alkermes Investigational Site
  • Seoul, Korea, Republic of
    • Alkermes Investigational Site
• Poland
  • Poznań, Poland
    • Alkermes Investigational Site
• Russian Federation
  • Arkhangel'sk, Russian Federation
    • Alkermes Investigational Site
  • Moscow, Russian Federation
    • Alkermes Investigational Site
  • Roshchino, Russian Federation
    • Alkermes Investigational Site
  • Rostov-on-Don, Russian Federation
    • Alkermes Investigational Site
  • Saint Petersburg, Russian Federation
    • Alkermes Investigational Site
  • Samara, Russian Federation
    • Alkermes Investigational Site
  • Saratov, Russian Federation
    • Alkermes Investigational Site
  • Tonnel'nyy, Russian Federation
    • Alkermes Investigational Site
• Spain
  • Oviedo, Spain
    • Alkermes Investigational Site
• Ukraine
  • Kharkiv, Ukraine
    • Alkermes Investigational Site
  • Kyiv, Ukraine
    • Alkermes Investigational Site
  • Lviv, Ukraine
    • Alkermes Investigational Site
  • Poltava, Ukraine
    • Alkermes Investigational Site
  • Smila, Ukraine
    • Alkermes Investigational Site
  • Stepanovka, Ukraine
    • Alkermes Investigational Site
• United Kingdom
  • Guildford, United Kingdom
    • Alkermes Investigational Site
  • Headington, United Kingdom
    • Alkermes Investigational Site
  • London, United Kingdom
    • Alkermes Investigational Site
  • Maidstone, United Kingdom
    • Alkermes Investigational Site
• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72211
      • Alkermes Investigational Site
    • Rogers, Arkansas, United States, 72758
      • Alkermes Investigational Site
  • California
    • Garden Grove, California, United States, 92845
      • Alkermes Investigational Site
    • San Diego, California, United States, 92013
      • Alkermes Investigational Site
    • Stanford, California, United States, 94305
      • Alkermes Investigational Site
  • Florida
    • Jacksonville, Florida, United States, 32209
      • Alkermes Investigational Site
    • North Miami, Florida, United States, 33161
      • Alkermes Investigational Site
  • Georgia
    • Atlanta, Georgia, United States, 30303
      • Alkermes Investigational Site
    • Atlanta, Georgia, United States, 30331
      • Alkermes Investigational Site
    • Augusta, Georgia, United States, 30912
      • Alkermes Investigational Site
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Alkermes Investigational Site
    • Winfield, Illinois, United States, 60190
      • Alkermes Investigational Site
  • Michigan
    • Kalamazoo, Michigan, United States, 49001
      • Alkermes Investigational Site
  • Missouri
    • Kansas City, Missouri, United States, 64108
      • Alkermes Investigational Site
    • Saint Louis, Missouri, United States, 63118
      • Alkermes Investigational Site
    • Saint Louis, Missouri, United States, 63128
      • Alkermes Investigational Site
    • Saint Louis, Missouri, United States, 63110
      • Alkermes Investigational Site
  • Nevada
    • Las Vegas, Nevada, United States, 89102
      • Alkermes Investigational Site
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • Alkermes Investigational Site
  • Oregon
    • Eugene, Oregon, United States, 97401
      • Alkermes Investigational Site
  • Texas
    • DeSoto, Texas, United States, 75115
      • Alkermes Investigational Site
    • Fort Worth, Texas, United States, 76104
      • Alkermes Investigational Site
    • Houston, Texas, United States, 77030
      • Alkermes Investigational Site
    • Richardson, Texas, United States, 75080
      • Alkermes Investigational Site
    • San Antonio, Texas, United States, 78201
      • Alkermes Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 40 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Has less than 24 weeks previous treatment with antipsychotics (cumulative; lifetime)

  • Subject treated with aripiprazole can receive an additional 1 year of treatment at ≤5 mg/day, and this treatment will not be considered as part of the 24 weeks of previous treatment with antipsychotics
• Has less than 4 years elapse since the initial onset of active-phase of symptoms
• Has a body mass index (BMI) of <30 kg/m^2
• Agrees to use an acceptable method of contraception for the duration of the study and for 30 days after the last dose of study drug
• Subject meets the criteria for a primary diagnosis of schizophrenia, schizophreniform disorder, or bipolar I disorder
• For bipolar I disorder, must have been experiencing an episode of acute mania within ≤14 days prior to Visit 1
• Suitable for outpatient treatment
• Additional criteria may apply

Exclusion Criteria:

• Poses a current suicide risk
• Has a history of poor or inadequate response to treatment with olanzapine
• Has previously been treated with long-acting injectable antipsychotic medication within the 2 months prior to screening, or has > 6 months cumulative life use, or has received treatment with electroconvulsive therapy in their lifetime
• Has initiated treatment with mood stabilizers (eg lithium, valproate, etc) >2 months prior to Visit 1
• Has a positive drug screen for opioids, phencyclidine (PCP), amphetamine/methamphetamine, or cocaine
• Has taken opioid agonists (eg, codeine, oxycodone, tramadol, morphine) within the 14 days prior to Visit 1, or has taken opioid antagonists, including naltrexone and naloxone, within 60 days prior to Visit 1
• Taking any weight loss agents or hypoglycemic agents
• Has a clinically significant or unstable medical illness, condition, or disorder that would be anticipated to potentially compromise subject safety or adversely affect the evaluation of efficacy
• Has joined a weight management program or had significant changes in diet or exercise regimen within the past 6 weeks
• Has started a smoking cessation program within the past 6 months
• Has a history of diabetes
• Currently pregnant or breastfeeding or is planning to become pregnant during the study or within 30 days of the last study drug administration
• Additional criteria may apply

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ALKS 3831; Coated bilayer tablet	Drug: ALKS 3831; Olanzapine + samidorphan, daily oral dosing
Active Comparator: Olanzapine; Coated bilayer tablet	Drug: Olanzapine; Daily oral dosing

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent Change From Baseline in Body Weight at Week 12	The efficacy analyses were performed using the Final Analysis Set which is defined as all randomized subjects who received one dose of study drug and had at least 1 primary efficacy assessment after administration of study drug	Baseline and 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Subjects With ≥10% Weight Gain at Week 12	Percentage of weight gain is analyzed based on the subject's assessment status (≥10% vs <10%) at Week 12 using a logistic regression model including treatment group, diagnosis (schizophrenia/schizophreniform disorder vs bipolar I disorder), region (US vs non-US), and baseline BMI (<25 vs ≥25) as factors and baseline weight as covariate.	Baseline and 12 weeks
Percentage of Subjects With ≥7% Weight Gain at Week 12		Baseline and 12 weeks
Number of Participants Experiencing of Adverse Events (AEs)		Up to 16 weeks
Change From Baseline in Waist Circumference at Week 12		Baseline and Week 12
Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score Within the ALKS 3831 Group at Week 12	Clinical Global Impression-Severity (CGI-S) Score is a 3-item, clinician-rated scale used to assess global illness severity, overall improvement from the start of treatment, and therapeutic response. It is a 7-point scale that requires the clinician to assess how mentally ill the patient is at a specific point in time. Based on the scale, patients are categorized as follows: "1: normal, not at all ill"; "2: borderline mentally ill"; "3: mildly ill"; "4: moderately ill"; "5: markedly ill"; "6: severely ill"; and "7: among the most extremely ill patients."	Baseline and Week 12

Collaborators and Investigators

• Sponsor: Alkermes, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): June 8, 2017
• Primary Completion (Actual): December 1, 2021
• Study Completion (Actual): January 3, 2022

Study Registration Dates

• First Submitted: June 8, 2017
• First Submitted That Met QC Criteria: June 13, 2017
• First Posted (Actual): June 15, 2017

Study Record Updates

• Last Update Posted (Actual): January 19, 2023
• Last Update Submitted That Met QC Criteria: December 22, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: Schizophrenia; Alkermes; Schizophreniform; Samidorphan; Olanzapine; ALKS 3831; Bipolar I
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia; Disease; Psychotic Disorders; Body Weight; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Antiemetics; Gastrointestinal Agents; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; Olanzapine
• Other Study ID Numbers: ALKS 3831-A307

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No