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

December 22, 2022 updated by: Alkermes, Inc.

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
426

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • 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

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

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 Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percent Change From Baseline in Body Weight at Week 12
Time Frame: Baseline and 12 weeks
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percentage of Subjects With ≥10% Weight Gain at Week 12
Time Frame: Baseline and 12 weeks
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
Time Frame: Baseline and 12 weeks
Baseline and 12 weeks
Number of Participants Experiencing of Adverse Events (AEs)
Time Frame: Up to 16 weeks
Up to 16 weeks
Change From Baseline in Waist Circumference at Week 12
Time Frame: Baseline and 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
Time Frame: Baseline and 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

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Alkermes, Inc.

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 8, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 3, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 8, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 13, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 15, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 19, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 22, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

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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