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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

Primary Purpose

Schizophrenia, Schizophreniform Disorders, Bipolar I Disorder

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
ALKS 3831
Olanzapine
Sponsored by
Alkermes, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring Alkermes, ALKS 3831, Olanzapine, Samidorphan, Schizophrenia, Schizophreniform, Bipolar I

Eligibility Criteria

16 Years - 40 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

ALKS 3831

Olanzapine

Arm Description

Coated bilayer tablet

Coated bilayer tablet

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
Percentage of Subjects With ≥7% Weight Gain at Week 12
Number of Participants Experiencing of Adverse Events (AEs)
Change From Baseline in Waist Circumference at 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."

Full Information

First Posted
June 8, 2017
Last Updated
December 22, 2022
Sponsor
Alkermes, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03187769
Brief Title
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
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
June 8, 2017 (Actual)
Primary Completion Date
December 1, 2021 (Actual)
Study Completion Date
January 3, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alkermes, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Schizophreniform Disorders, Bipolar I Disorder
Keywords
Alkermes, ALKS 3831, Olanzapine, Samidorphan, Schizophrenia, Schizophreniform, Bipolar I

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
426 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ALKS 3831
Arm Type
Experimental
Arm Description
Coated bilayer tablet
Arm Title
Olanzapine
Arm Type
Active Comparator
Arm Description
Coated bilayer tablet
Intervention Type
Drug
Intervention Name(s)
ALKS 3831
Intervention Description
Olanzapine + samidorphan, daily oral dosing
Intervention Type
Drug
Intervention Name(s)
Olanzapine
Intervention Description
Daily oral dosing
Primary Outcome Measure Information:
Title
Percent Change From Baseline in Body Weight at Week 12
Description
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
Time Frame
Baseline and 12 weeks
Secondary Outcome Measure Information:
Title
Percentage of Subjects With ≥10% Weight Gain at Week 12
Description
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.
Time Frame
Baseline and 12 weeks
Title
Percentage of Subjects With ≥7% Weight Gain at Week 12
Time Frame
Baseline and 12 weeks
Title
Number of Participants Experiencing of Adverse Events (AEs)
Time Frame
Up to 16 weeks
Title
Change From Baseline in Waist Circumference at Week 12
Time Frame
Baseline and Week 12
Title
Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score Within the ALKS 3831 Group at Week 12
Description
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."
Time Frame
Baseline and Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alkermes Medical Director
Organizational Affiliation
Alkermes, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Alkermes Investigational Site
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72211
Country
United States
Facility Name
Alkermes Investigational Site
City
Rogers
State/Province
Arkansas
ZIP/Postal Code
72758
Country
United States
Facility Name
Alkermes Investigational Site
City
Garden Grove
State/Province
California
ZIP/Postal Code
92845
Country
United States
Facility Name
Alkermes Investigational Site
City
San Diego
State/Province
California
ZIP/Postal Code
92013
Country
United States
Facility Name
Alkermes Investigational Site
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
Alkermes Investigational Site
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32209
Country
United States
Facility Name
Alkermes Investigational Site
City
North Miami
State/Province
Florida
ZIP/Postal Code
33161
Country
United States
Facility Name
Alkermes Investigational Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30303
Country
United States
Facility Name
Alkermes Investigational Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30331
Country
United States
Facility Name
Alkermes Investigational Site
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Facility Name
Alkermes Investigational Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Alkermes Investigational Site
City
Winfield
State/Province
Illinois
ZIP/Postal Code
60190
Country
United States
Facility Name
Alkermes Investigational Site
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49001
Country
United States
Facility Name
Alkermes Investigational Site
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64108
Country
United States
Facility Name
Alkermes Investigational Site
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Alkermes Investigational Site
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63118
Country
United States
Facility Name
Alkermes Investigational Site
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63128
Country
United States
Facility Name
Alkermes Investigational Site
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89102
Country
United States
Facility Name
Alkermes Investigational Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Alkermes Investigational Site
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97401
Country
United States
Facility Name
Alkermes Investigational Site
City
DeSoto
State/Province
Texas
ZIP/Postal Code
75115
Country
United States
Facility Name
Alkermes Investigational Site
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
Alkermes Investigational Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Alkermes Investigational Site
City
Richardson
State/Province
Texas
ZIP/Postal Code
75080
Country
United States
Facility Name
Alkermes Investigational Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78201
Country
United States
Facility Name
Alkermes Investigational Site
City
Vienna
Country
Austria
Facility Name
Alkermes Investigational Site
City
Muenchen
Country
Germany
Facility Name
Alkermes Investigational Site
City
Galway
Country
Ireland
Facility Name
Alkermes Investigational Site
City
Jerusalem
Country
Israel
Facility Name
Alkermes Investigational Site
City
Tel HaShomer
Country
Israel
Facility Name
Alkermes Investigational Site
City
Brescia
Country
Italy
Facility Name
Alkermes Investigational Site
City
Naples
Country
Italy
Facility Name
Alkermes Investigational Site
City
Torino
Country
Italy
Facility Name
Alkermes Investigational Site
City
Busan
Country
Korea, Republic of
Facility Name
Alkermes Investigational Site
City
Daegu
Country
Korea, Republic of
Facility Name
Alkermes Investigational Site
City
Naju
Country
Korea, Republic of
Facility Name
Alkermes Investigational Site
City
Seoul
Country
Korea, Republic of
Facility Name
Alkermes Investigational Site
City
Poznań
Country
Poland
Facility Name
Alkermes Investigational Site
City
Arkhangel'sk
Country
Russian Federation
Facility Name
Alkermes Investigational Site
City
Moscow
Country
Russian Federation
Facility Name
Alkermes Investigational Site
City
Roshchino
Country
Russian Federation
Facility Name
Alkermes Investigational Site
City
Rostov-on-Don
Country
Russian Federation
Facility Name
Alkermes Investigational Site
City
Saint Petersburg
Country
Russian Federation
Facility Name
Alkermes Investigational Site
City
Samara
Country
Russian Federation
Facility Name
Alkermes Investigational Site
City
Saratov
Country
Russian Federation
Facility Name
Alkermes Investigational Site
City
Tonnel'nyy
Country
Russian Federation
Facility Name
Alkermes Investigational Site
City
Oviedo
Country
Spain
Facility Name
Alkermes Investigational Site
City
Kharkiv
Country
Ukraine
Facility Name
Alkermes Investigational Site
City
Kyiv
Country
Ukraine
Facility Name
Alkermes Investigational Site
City
Lviv
Country
Ukraine
Facility Name
Alkermes Investigational Site
City
Poltava
Country
Ukraine
Facility Name
Alkermes Investigational Site
City
Smila
Country
Ukraine
Facility Name
Alkermes Investigational Site
City
Stepanovka
Country
Ukraine
Facility Name
Alkermes Investigational Site
City
Guildford
Country
United Kingdom
Facility Name
Alkermes Investigational Site
City
Headington
Country
United Kingdom
Facility Name
Alkermes Investigational Site
City
London
Country
United Kingdom
Facility Name
Alkermes Investigational Site
City
Maidstone
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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