A Study of Aripiprazole Lauroxil or Paliperidone Palmitate for the Treatment of Schizophrenia

Last updated: July 29, 2020
Sponsor: Alkermes, Inc.
Overall Status: Completed

Phase

3

Condition

Tourette's Syndrome

Mood Disorders

Psychosis

Treatment

N/A

Clinical Study ID

NCT03345979
ALK9072-A306
  • Ages 18-65
  • All Genders

Study Summary

This study will evaluate the efficacy of initiating treatment of schizophrenia with ARISTADA INITIO plus 30 mg oral aripiprazole followed by a 2-month dose of AL.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Has a diagnosis of schizophrenia

  • Requires acute treatment for symptoms of schizophrenia

  • Willing and able to be confined to an inpatient study unit for up to 3-4 weeks

  • Has experienced at least one previous hospitalization for schizophrenia

  • Has been able to achieve outpatient status for more than 3 months in the past year

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

  • Resides in a stable living situation when not hospitalized

  • Has an identified reliable caregiver (for example, family member)

  • Additional criteria may apply

Exclusion

Exclusion Criteria:

  • Poses a current suicide risk

  • Pregnant, planning to become pregnant, or breastfeeding

  • Initiated first antipsychotic treatment within the past 12 months

  • Has received a long-acting injectable antipsychotic in the past 3 months

  • Has participated in a clinical study involving any investigational product within thepast 3 months, or is currently participating in a clinical study involving aninvestigational product.

  • A positive urine drug test for drugs of abuse

  • Additional criteria may apply

Study Design

Total Participants: 200
Study Start date:
November 15, 2017
Estimated Completion Date:
March 12, 2019

Connect with a study center

  • 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

    Cerritos, California 90703
    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

    Hialeah, Florida 33012
    United States

    Site Not Available

  • Alkermes Investigational Site

    Chicago, Illinois 60640
    United States

    Site Not Available

  • Alkermes Investigational Site

    Hoffman Estates, Illinois 60169
    United States

    Site Not Available

  • Alkermes Investigational Site

    Flowood, Mississippi 39232
    United States

    Site Not Available

  • Alkermes Investigational Site

    Saint Louis, Missouri 63141
    United States

    Site Not Available

  • Alkermes Investigational Site

    Las Vegas, Nevada 89102
    United States

    Site Not Available

  • Alkermes Investigational Site

    Berlin, New Jersey 08009
    United States

    Site Not Available

  • Alkermes Investigational Site

    Austin, Texas 78754
    United States

    Site Not Available

  • Alkermes Investigational Site

    Garland, Texas 75042
    United States

    Site Not Available

  • Alkermes Investigational Site

    Richardson, Texas 75080
    United States

    Site Not Available

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