A Study of ALKS 3831 in Adults With Acute Exacerbation of Schizophrenia (the ENLIGHTEN-1 Study)

Last updated: May 25, 2018
Sponsor: Alkermes, Inc.
Overall Status: Completed

Phase

3

Condition

Schizotypal Personality Disorder (Spd)

Psychosis

Tourette's Syndrome

Treatment

N/A

Clinical Study ID

NCT02634346
ALKS-3831-A305
  • Ages 18-70
  • All Genders

Study Summary

This study will evaluate the efficacy of ALKS 3831 in adult subjects with acute exacerbation of schizophrenia.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Has a body mass index (BMI) of 18.0 - 40.0 kg/m^2

  • Meets criteria for the diagnosis of schizophrenia

  • Resides in a stable living situation when not hospitalized

  • Is willing and able to provide government-issued identification

  • Additional criteria may apply

Exclusion

Exclusion Criteria:

  • Has had a psychiatric hospitalization for more than 30 days during the 90 days beforescreening

  • Subject initiated first antipsychotic treatment within the past 12 months, or <1 yearhas elapsed since the initial onset of active-phase of schizophrenia symptoms

  • Subject poses a current suicide risk

  • Subject has a history of treatment resistance

  • Subject has a history of poor or inadequate response to treatment with olanzapine

  • Subject requires or has had electroconvulsive therapy (ECT) treatment in the 2-monthperiod prior to screening

  • Subject has a diagnosis of moderate or severe alcohol or drug use disorder

  • Subject has a positive urine drug screen for opioids, amphetamine/methamphetamine,phencyclidine, or cocaine at screening

  • Additional criteria may apply

Study Design

Total Participants: 403
Study Start date:
December 01, 2015
Estimated Completion Date:
June 07, 2017

Connect with a study center

  • Alkermes Investigational Site

    Burgas,
    Bulgaria

    Site Not Available

  • Alkermes Investigational Site

    Kazanlak,
    Bulgaria

    Site Not Available

  • Alkermes Investigational Site

    Lovech,
    Bulgaria

    Site Not Available

  • Alkermes Investigational Site

    Novi Iskar,
    Bulgaria

    Site Not Available

  • Alkermes Investigational Site

    Plovdiv,
    Bulgaria

    Site Not Available

  • Alkermes Investigational Site

    Veliko Tarnovo,
    Bulgaria

    Site Not Available

  • Alkermes Investigational Site

    Vratsa,
    Bulgaria

    Site Not Available

  • Alkermes Investigational Site

    Belgrade,
    Serbia

    Site Not Available

  • Alkermes Investigational Site

    Krabujevac,
    Serbia

    Site Not Available

  • Alkermes Investigational Site

    Novi Knezevac,
    Serbia

    Site Not Available

  • Alkermes Investigational Site

    Cherkasy,
    Ukraine

    Site Not Available

  • Alkermes Investigational Site

    Kherson,
    Ukraine

    Site Not Available

  • Alkermes Investigational Site

    Kiev,
    Ukraine

    Site Not Available

  • Alkermes Investigational Site

    L'viv,
    Ukraine

    Site Not Available

  • Alkermes Investigational Site

    Vinnytsia,
    Ukraine

    Site Not Available

  • Alkermes Investigational Site

    Little Rock, Arkansas 72211
    United States

    Site Not Available

  • Alkermes Investigational Site

    Springdale, Arkansas 72764
    United States

    Site Not Available

  • Alkermes Investigational Site

    Culver City, California 90230
    United States

    Site Not Available

  • Alkermes Investigational Site

    Garden Grove, California 92845
    United States

    Site Not Available

  • Alkermes Investigational Site

    Lemon Grove, California 91945
    United States

    Site Not Available

  • Alkermes Investigational Site

    Long Beach, California 90822
    United States

    Site Not Available

  • Alkermes Investigational Site

    National City, California 91950
    United States

    Site Not Available

  • Alkermes Investigational Site

    Orange, California 92868
    United States

    Site Not Available

  • Alkermes Investigational Site

    San Diego, California 92103
    United States

    Site Not Available

  • Alkermes Investigational Site

    Washington, District of Columbia 20016
    United States

    Site Not Available

  • Alkermes Investigational Site

    Washington, D.C., District of Columbia 20016
    United States

    Site Not Available

  • Alkermes Investigational Site

    North Miami, Florida 33161
    United States

    Site Not Available

  • Alkermes Investigational Site

    Chicago, Illinois 60640
    United States

    Site Not Available

  • Alkermes Investigational Site

    Saint Louis, Missouri 63141
    United States

    Site Not Available

  • Alkermes Investigational Site

    St. Louis, Missouri 63141
    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

    Dayton, Ohio 45417
    United States

    Site Not Available

  • Alkermes Investigational Site

    Dallas, Texas 75243
    United States

    Site Not Available

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