search
Back to results

A Study of ALKS 3831 in Adults With Schizophrenia

Primary Purpose

Schizophrenia

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Samidorphan (Low Dose)
Samidorphan (Medium Dose)
Samidorphan (High Dose)
Placebo
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 Schizophrenia, Olanzapine, Samidorphan, Alkermes

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age 18 to 50 years, inclusive
  • Body mass index (BMI) of 17-30 kg/m2, inclusive
  • Diagnosis of schizophrenia that is clinically stable

Exclusion Criteria:

  • Initiated 1st antipsychotic treatment within the past 12 months and/or has had symptoms lasting <2 years
  • Current diagnosis of alcohol or drug use disorder, moderate or severe
  • Clinically significant or unstable medical illness, condition, or disorder
  • Pregnant or breastfeeding
  • Significant changes in diet or exercise regimen or plans to join a weight management program during the study
  • Opioid medications taken within 14 days and/or need to take opioid medication during the study period
  • History of hypersensitivity to or intolerance of olanzapine
  • Use of olanzapine, clozapine, mesoridazine, chlorpromazine, or thioridazine for more than 1 week during the past year

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

Low Dose

Medium Dose

High Dose

Placebo

Arm Description

Olanzapine + low dose samidorphan tablets taken once daily

Olanzapine + medium dose samidorphan tablets taken once daily

Olanzapine + high dose samidorphan tablets taken once daily

Olanzapine + placebo tablets taken once daily

Outcomes

Primary Outcome Measures

Absolute Change in Total Positive and Negative Syndrome Scale (PANSS) Score
Change from baseline (Day 8) to Day 92 (end of study Part A). The PANSS is a 30-item scale measuring severity of schizophrenia symptoms. Symptom severity for each item is rated on a 7-point scale (1 = absent; 7 = extreme), and the total score is added together, with a minimum score of 30 and a maximum score of 210. A higher score indicates more severe symptoms, while a lower score indicates less severe symptoms.

Secondary Outcome Measures

Percent Change in Body Weight (Kilogram) From Baseline to Day 92
Percent change from baseline (Day 8) to the end of Part A (Day 92)
Absolute Change in Body Weight (kg) From Baseline to Day 92
Change from randomization (Day 8) to the end of Part A (Week 12; Day 92)
Percentage of Subjects Exhibiting Significant Weight Gain at Day 92
Significant weight gain will include a >=5%, >= 7%, or >=10% gain in body weight from baseline (Day 8) to Day 92 (end of study Part A)
Change in Clinical Global Impressions - Severity (CGI-S) From Baseline to Day 92
Change in CGI-S score from baseline (Day 8) to the end of Part A (Week 12; Day 92). The CGI-S is a 7-point scale intended to measure the severity of a patient's illness at the time of assessment. Scores range from 1 (normal) to 7(extremely ill), so a higher score is correlative to more severe illness.

Full Information

First Posted
July 5, 2013
Last Updated
September 10, 2021
Sponsor
Alkermes, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT01903837
Brief Title
A Study of ALKS 3831 in Adults With Schizophrenia
Official Title
A Phase 2, Randomized, Multicenter, Safety, Tolerability, and Dose-Ranging Study of Samidorphan, a Component of ALKS 3831, in Adults With Schizophrenia Treated With Olanzapine
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
June 2013 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
March 2015 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is a Phase 2, randomized, placebo-controlled multicenter study, which will be conducted in 2 parts. The study duration for each subject will be approximately 33 weeks and will include 25 study visits.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Schizophrenia, Olanzapine, Samidorphan, Alkermes

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
347 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Low Dose
Arm Type
Experimental
Arm Description
Olanzapine + low dose samidorphan tablets taken once daily
Arm Title
Medium Dose
Arm Type
Experimental
Arm Description
Olanzapine + medium dose samidorphan tablets taken once daily
Arm Title
High Dose
Arm Type
Experimental
Arm Description
Olanzapine + high dose samidorphan tablets taken once daily
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Olanzapine + placebo tablets taken once daily
Intervention Type
Drug
Intervention Name(s)
Samidorphan (Low Dose)
Other Intervention Name(s)
Low dose samidorphan (ALKS 33)
Intervention Description
Tablets taken once daily
Intervention Type
Drug
Intervention Name(s)
Samidorphan (Medium Dose)
Other Intervention Name(s)
Medium dose samidorphan (ALKS 33)
Intervention Description
Tablets taken once daily
Intervention Type
Drug
Intervention Name(s)
Samidorphan (High Dose)
Other Intervention Name(s)
High dose samidorphan (ALKS 33)
Intervention Description
Tablets taken once daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Tablets taken once daily
Intervention Type
Drug
Intervention Name(s)
Olanzapine
Intervention Description
Tablets taken once daily
Primary Outcome Measure Information:
Title
Absolute Change in Total Positive and Negative Syndrome Scale (PANSS) Score
Description
Change from baseline (Day 8) to Day 92 (end of study Part A). The PANSS is a 30-item scale measuring severity of schizophrenia symptoms. Symptom severity for each item is rated on a 7-point scale (1 = absent; 7 = extreme), and the total score is added together, with a minimum score of 30 and a maximum score of 210. A higher score indicates more severe symptoms, while a lower score indicates less severe symptoms.
Time Frame
Baseline (Day 8) to Day 92 (end of study Part A)
Secondary Outcome Measure Information:
Title
Percent Change in Body Weight (Kilogram) From Baseline to Day 92
Description
Percent change from baseline (Day 8) to the end of Part A (Day 92)
Time Frame
Baseline (Day 8) to Day 92 (end of study Part A)
Title
Absolute Change in Body Weight (kg) From Baseline to Day 92
Description
Change from randomization (Day 8) to the end of Part A (Week 12; Day 92)
Time Frame
Baseline (Day 8) to Day 92 (end of study Part A)
Title
Percentage of Subjects Exhibiting Significant Weight Gain at Day 92
Description
Significant weight gain will include a >=5%, >= 7%, or >=10% gain in body weight from baseline (Day 8) to Day 92 (end of study Part A)
Time Frame
Baseline (Day 8) to Day 92 (end of study Part A)
Title
Change in Clinical Global Impressions - Severity (CGI-S) From Baseline to Day 92
Description
Change in CGI-S score from baseline (Day 8) to the end of Part A (Week 12; Day 92). The CGI-S is a 7-point scale intended to measure the severity of a patient's illness at the time of assessment. Scores range from 1 (normal) to 7(extremely ill), so a higher score is correlative to more severe illness.
Time Frame
Baseline (Day 8) to Day 92 (end of study Part A)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18 to 50 years, inclusive Body mass index (BMI) of 17-30 kg/m2, inclusive Diagnosis of schizophrenia that is clinically stable Exclusion Criteria: Initiated 1st antipsychotic treatment within the past 12 months and/or has had symptoms lasting <2 years Current diagnosis of alcohol or drug use disorder, moderate or severe Clinically significant or unstable medical illness, condition, or disorder Pregnant or breastfeeding Significant changes in diet or exercise regimen or plans to join a weight management program during the study Opioid medications taken within 14 days and/or need to take opioid medication during the study period History of hypersensitivity to or intolerance of olanzapine Use of olanzapine, clozapine, mesoridazine, chlorpromazine, or thioridazine for more than 1 week during the past year
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bernard L. Silverman, MD
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
Anaheim
State/Province
California
ZIP/Postal Code
92805
Country
United States
Facility Name
Alkermes Investigational Site
City
Costa Mesa
State/Province
California
ZIP/Postal Code
92626
Country
United States
Facility Name
Alkermes Investigational Site
City
Culver City
State/Province
California
ZIP/Postal Code
90230
Country
United States
Facility Name
Alkermes Investigational Site
City
Escondido
State/Province
California
ZIP/Postal Code
92025
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
National City
State/Province
California
ZIP/Postal Code
91950
Country
United States
Facility Name
Alkermes Investigational Site
City
Oakland
State/Province
California
ZIP/Postal Code
94612
Country
United States
Facility Name
Alkermes Investigational Site
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
Facility Name
Alkermes Investigational Site
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Alkermes Investigational Site
City
Pico Rivera
State/Province
California
ZIP/Postal Code
90660
Country
United States
Facility Name
Alkermes Investigational Site
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Alkermes Investigational Site
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
Facility Name
Alkermes Investigational Site
City
New Britain
State/Province
Connecticut
ZIP/Postal Code
06052
Country
United States
Facility Name
Alkermes Investigational Site
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20016
Country
United States
Facility Name
Alkermes Investigational Site
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34208
Country
United States
Facility Name
Alkermes Investigational Site
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33308
Country
United States
Facility Name
Alkermes Investigational Site
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32607
Country
United States
Facility Name
Alkermes Investigational Site
City
Kissimmee
State/Province
Florida
ZIP/Postal Code
34741
Country
United States
Facility Name
Alkermes Investigational Site
City
Leesburg
State/Province
Florida
ZIP/Postal Code
34748
Country
United States
Facility Name
Alkermes Investigational Site
City
Oakland Park
State/Province
Florida
ZIP/Postal Code
33334
Country
United States
Facility Name
Alkermes Investigational Site
City
Orlando
State/Province
Florida
ZIP/Postal Code
32810
Country
United States
Facility Name
Alkermes Investigational Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Facility Name
Alkermes Investigational Site
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30030
Country
United States
Facility Name
Alkermes Investigational Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60640
Country
United States
Facility Name
Alkermes Investigational Site
City
Lake Charles
State/Province
Louisiana
ZIP/Postal Code
70629
Country
United States
Facility Name
Alkermes Investigational Site
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71101
Country
United States
Facility Name
Alkermes Investigational Site
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20850
Country
United States
Facility Name
Alkermes Investigational Site
City
Flowood
State/Province
Mississippi
ZIP/Postal Code
39232
Country
United States
Facility Name
Alkermes Investigational Site
City
Creve Coeur
State/Province
Missouri
ZIP/Postal Code
63141
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
Marlton
State/Province
New Jersey
ZIP/Postal Code
08053
Country
United States
Facility Name
Alkermes Investigational Site
City
Neptune
State/Province
New Jersey
ZIP/Postal Code
07754
Country
United States
Facility Name
Alkermes Investigational Site
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
Facility Name
Alkermes Investigational Site
City
Mason
State/Province
Ohio
ZIP/Postal Code
45040
Country
United States
Facility Name
Alkermes Investigational Site
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73103
Country
United States
Facility Name
Alkermes Investigational Site
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73116
Country
United States
Facility Name
Alkermes Investigational Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19139
Country
United States
Facility Name
Alkermes Investigational Site
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29407
Country
United States
Facility Name
Alkermes Investigational Site
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
Alkermes Investigational Site
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Facility Name
Alkermes Investigational Site
City
Austin
State/Province
Texas
ZIP/Postal Code
78754
Country
United States
Facility Name
Alkermes Investigational Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Alkermes Investigational Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75243
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
Houston
State/Province
Texas
ZIP/Postal Code
77007
Country
United States
Facility Name
Alkermes Investigational Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77008
Country
United States
Facility Name
Alkermes Investigational Site
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84106
Country
United States
Facility Name
Alkermes Investigational Site
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98007
Country
United States
Facility Name
Alkermes Investigational Site
City
Richland
State/Province
Washington
ZIP/Postal Code
99362
Country
United States
Facility Name
Alkermes Investigational Site
City
Burgas
ZIP/Postal Code
8000
Country
Bulgaria
Facility Name
Alkermes Investigational Site
City
Kazanlak
ZIP/Postal Code
6100
Country
Bulgaria
Facility Name
Alkermes Investigational Site
City
Lovech
ZIP/Postal Code
5500
Country
Bulgaria
Facility Name
Alkermes Investigational Site
City
Novi Iskar
ZIP/Postal Code
1280
Country
Bulgaria
Facility Name
Alkermes Investigational Site
City
Pazardzhik
ZIP/Postal Code
4400
Country
Bulgaria
Facility Name
Alkermes Investigational Site
City
Sofia
ZIP/Postal Code
1606
Country
Bulgaria
Facility Name
Alkermes Investigational Site
City
Tserova Koria
ZIP/Postal Code
8260
Country
Bulgaria
Facility Name
Alkermes Investigational Site
City
Varna
ZIP/Postal Code
9020
Country
Bulgaria
Facility Name
Alkermes Investigational Site
City
Vratsa
ZIP/Postal Code
3000
Country
Bulgaria
Facility Name
Alkermes Investigational Site
City
Brno-mesto
Country
Czechia
Facility Name
Alkermes Investigational Site
City
Praha
Country
Czechia

12. IPD Sharing Statement

Citations:
PubMed Identifier
30845818
Citation
Martin WF, Correll CU, Weiden PJ, Jiang Y, Pathak S, DiPetrillo L, Silverman BL, Ehrich EW. Mitigation of Olanzapine-Induced Weight Gain With Samidorphan, an Opioid Antagonist: A Randomized Double-Blind Phase 2 Study in Patients With Schizophrenia. Am J Psychiatry. 2019 Jun 1;176(6):457-467. doi: 10.1176/appi.ajp.2018.18030280. Epub 2019 Mar 8.
Results Reference
result

Learn more about this trial

A Study of ALKS 3831 in Adults With Schizophrenia

We'll reach out to this number within 24 hrs