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

Last updated: December 22, 2022
Sponsor: Alkermes, Inc.
Overall Status: Completed

Phase

3

Condition

Tourette's Syndrome

Schizotypal Personality Disorder (Spd)

Schizophrenia And Schizoaffective Disorders (Pediatric)

Treatment

N/A

Clinical Study ID

NCT03187769
ALKS 3831-A307
  • Ages 16-40
  • All Genders

Study 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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Has less than 24 weeks previous treatment with antipsychotics (cumulative; lifetime)
  • Subject treated with aripiprazole can receive an additional 1 year of treatmentat ≤5 mg/day, and this treatment will not be considered as part of the 24 weeksof 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 andfor 30 days after the last dose of study drug
  • Subject meets the criteria for a primary diagnosis of schizophrenia, schizophreniformdisorder, 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

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 medicationwithin the 2 months prior to screening, or has > 6 months cumulative life use, or hasreceived treatment with electroconvulsive therapy in their lifetime
  • Has initiated treatment with mood stabilizers (eg lithium, valproate, etc) >2 monthsprior 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 14days prior to Visit 1, or has taken opioid antagonists, including naltrexone andnaloxone, 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 thatwould be anticipated to potentially compromise subject safety or adversely affect theevaluation of efficacy
  • Has joined a weight management program or had significant changes in diet or exerciseregimen 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 studyor within 30 days of the last study drug administration
  • Additional criteria may apply

Study Design

Total Participants: 426
Study Start date:
June 08, 2017
Estimated Completion Date:
January 03, 2022

Study Description

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

Connect with a study center

  • Alkermes Investigational Site

    Vienna,
    Austria

    Site Not Available

  • Alkermes Investigational Site

    Muenchen,
    Germany

    Site Not Available

  • Alkermes Investigational Site

    Galway,
    Ireland

    Site Not Available

  • Alkermes Investigational Site

    Jerusalem,
    Israel

    Site Not Available

  • Alkermes Investigational Site

    Tel HaShomer,
    Israel

    Site Not Available

  • Alkermes Investigational Site

    Brescia,
    Italy

    Site Not Available

  • Alkermes Investigational Site

    Naples,
    Italy

    Site Not Available

  • Alkermes Investigational Site

    Torino,
    Italy

    Site Not Available

  • Alkermes Investigational Site

    Busan,
    Korea, Republic of

    Site Not Available

  • Alkermes Investigational Site

    Daegu,
    Korea, Republic of

    Site Not Available

  • Alkermes Investigational Site

    Naju,
    Korea, Republic of

    Site Not Available

  • Alkermes Investigational Site

    Seoul,
    Korea, Republic of

    Site Not Available

  • Alkermes Investigational Site

    Poznań,
    Poland

    Site Not Available

  • Alkermes Investigational Site

    Warsaw,
    Poland

    Site Not Available

  • Alkermes Investigational Site

    Arkhangel'sk,
    Russian Federation

    Site Not Available

  • Alkermes Investigational Site

    Moscow,
    Russian Federation

    Site Not Available

  • Alkermes Investigational Site

    Roshchino,
    Russian Federation

    Site Not Available

  • Alkermes Investigational Site

    Rostov-on-Don,
    Russian Federation

    Site Not Available

  • Alkermes Investigational Site

    Saint Petersburg,
    Russian Federation

    Site Not Available

  • Alkermes Investigational Site

    Samara,
    Russian Federation

    Site Not Available

  • Alkermes Investigational Site

    Saratov,
    Russian Federation

    Site Not Available

  • Alkermes Investigational Site

    Tonnel'nyy,
    Russian Federation

    Site Not Available

  • Alkermes Investigational Site

    Oviedo,
    Spain

    Site Not Available

  • Alkermes Investigational Site

    Santander,
    Spain

    Site Not Available

  • Alkermes Investigational Site

    Kharkiv,
    Ukraine

    Site Not Available

  • Alkermes Investigational Site

    Kyiv,
    Ukraine

    Site Not Available

  • Alkermes Investigational Site

    Lviv,
    Ukraine

    Site Not Available

  • Alkermes Investigational Site

    Poltava,
    Ukraine

    Site Not Available

  • Alkermes Investigational Site

    Smila,
    Ukraine

    Site Not Available

  • Alkermes Investigational Site

    Stepanovka,
    Ukraine

    Site Not Available

  • Alkermes Investigational Site

    Guildford,
    United Kingdom

    Site Not Available

  • Alkermes Investigational Site

    Headington,
    United Kingdom

    Site Not Available

  • Alkermes Investigational Site

    London,
    United Kingdom

    Site Not Available

  • Alkermes Investigational Site

    Maidstone,
    United Kingdom

    Site Not Available

  • Alkermes Investigational Site

    Little Rock, Arkansas 72211
    United States

    Site Not Available

  • Alkermes Investigational Site

    Rogers, Arkansas 72758
    United States

    Site Not Available

  • Alkermes Investigational Site

    Garden Grove, California 92845
    United States

    Site Not Available

  • Alkermes Investigational Site

    National City, California 91950
    United States

    Site Not Available

  • Alkermes Investigational Site

    San Diego, California 92013
    United States

    Site Not Available

  • Alkermes Investigational Site

    Stanford, California 94305
    United States

    Site Not Available

  • Alkermes Investigational Site

    Jacksonville, Florida 32209
    United States

    Site Not Available

  • Alkermes Investigational Site

    North Miami, Florida 33161
    United States

    Site Not Available

  • Alkermes Investigational Site

    West Palm Beach, Florida 33407
    United States

    Site Not Available

  • Alkermes Investigational Site

    Atlanta, Georgia 30303
    United States

    Site Not Available

  • Alkermes Investigational Site

    Augusta, Georgia 30912
    United States

    Site Not Available

  • Alkermes Investigational Site

    Chicago, Illinois 60611
    United States

    Site Not Available

  • Alkermes Investigational Site

    Hoffman Estates, Illinois 60169
    United States

    Site Not Available

  • Alkermes Investigational Site

    Winfield, Illinois 60190
    United States

    Site Not Available

  • Alkermes Investigational Site

    Iowa City, Iowa 52242
    United States

    Site Not Available

  • Alkermes Investigational Site

    Kalamazoo, Michigan 49001
    United States

    Site Not Available

  • Alkermes Investigational Site

    Muskegon, Michigan 49442
    United States

    Site Not Available

  • Alkermes Investigational Site

    Kansas City, Missouri 64108
    United States

    Site Not Available

  • Alkermes Investigational Site

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • Alkermes Investigational Site

    Las Vegas, Nevada 89102
    United States

    Site Not Available

  • Alkermes Investigational Site

    Marlton, New Jersey 08053
    United States

    Site Not Available

  • Alkermes Investigational Site

    Durham, North Carolina 27707
    United States

    Site Not Available

  • Alkermes Investigational Site

    Cincinnati, Ohio 45219
    United States

    Site Not Available

  • Alkermes Investigational Site

    Eugene, Oregon 97401
    United States

    Site Not Available

  • Alkermes Investigational Site

    Austin, Texas 78754
    United States

    Site Not Available

  • Alkermes Investigational Site

    DeSoto, Texas 75115
    United States

    Site Not Available

  • Alkermes Investigational Site

    Fort Worth, Texas 76104
    United States

    Site Not Available

  • Alkermes Investigational Site

    Houston, Texas 77030
    United States

    Site Not Available

  • Alkermes Investigational Site

    Richardson, Texas 75080
    United States

    Site Not Available

  • Alkermes Investigational Site

    San Antonio, Texas 78201
    United States

    Site Not Available

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