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Completed

NCT Number: NCT03345979

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

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.

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Key information

Conditions

Schizophrenia Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Alkermes Investigational Site, Little Rock, Arkansas, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 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 the past 3 months, or is currently participating in a clinical study involving an investigational product.
  • A positive urine drug test for drugs of abuse
  • Additional criteria may apply

Treatment and study plan

Aripiprazole Lauroxil

Combination Product

Intramuscular injection; study drug provided using a pre-filled syringe

Other names: ARISTADA, ARISTADA INITIO

Paliperidone palmitate

Drug

Intramuscular injection

Other names: Invega Sustenna

Primary outcomes

  1. Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score at Week 4

    Time frame: Baseline and 4 weeks

    Change within treatment groups of Positive and Negative Syndrome Scale (PANSS) total score between baseline and week 4 based on the observed data without imputation for missing data. The PANSS scale contains 30 questions, each containing an answer range of 1-7. A total PANSS score can range from between 30 to 210; a higher score indicates a worse disease condition.

Secondary outcomes

  1. Least Squares Mean Change in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 4

    Time frame: Baseline and 4 weeks

    Least squares mean change in Positive and Negative Syndrome Scale (PANSS) between at 4 weeks from Mixed Models Repeated Measures (MMRM). The PANSS scale contains 30 questions, each containing an answer range of 1-7. A total PANSS score can range from between 30 to 210; a higher score indicates a worse disease condition

  2. Change in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 9

    Time frame: Baseline and 9 weeks

    Change within treatment groups from baseline Positive and Negative Syndrome Scale (PANSS) and 9 weeks based on the observed data without imputation for missing data. The PANSS scale contains 30 questions, each containing an answer range of 1-7. A total PANSS score can range from between 30 to 210; a higher score indicates a worse disease condition.

  3. Change in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 25

    Time frame: Baseline and 25 weeks

    Change within treatment groups at baseline Positive and Negative Syndrome Scale (PANSS) and at 25 weeks based on the observed data without imputation for missing data. The PANSS scale contains 30 questions, each containing an answer range of 1-7. A total PANSS score can range from between 30 to 210; a higher score indicates a worse disease condition

  4. Least Squares Mean Change in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 9

    Time frame: Baseline and 9 weeks

    Least squares mean change from baseline Positive and Negative Syndrome Scale (PANSS) and 9 weeks from Mixed Models Repeated Measures (MMRM).The PANSS scale contains 30 questions, each containing an answer range of 1-7. A total PANSS score can range from between 30 to 210; a higher score indicates a worse disease condition

  5. Least Squares Mean Change in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 25

    Time frame: Baseline and 25 weeks

    Least squares mean change in Positive and Negative Syndrome Scale (PANSS) total score at week 25 from Mixed Models Repeated Measures. The PANSS scale contains 30 questions, each containing an answer range of 1-7. A total PANSS score can range from between 30 to 210; a higher score indicates a worse disease condition

  6. Number of Participants With Serious and Non-serious Adverse Events (AEs)

    Time frame: Up to 25 weeks

Sponsors and collaborators

Lead sponsor

Alkermes, Inc.

Industry

Registry information

Official study title

A Phase 3b, Multicenter, Randomized, Double-blind Study to Evaluate the Efficacy and Safety of Aripiprazole Lauroxil or Paliperidone Palmitate for the Treatment of Schizophrenia in Subjects Hospitalized for Acute Exacerbation

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Nov 17, 2017
Registry last updated
Aug 11, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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