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

Alkermes, Inc.200 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

200

Conditions

Schizophrenia

Interventions

Aripiprazole LauroxilCOMBINATION_PRODUCT

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

Paliperidone PalmitateDRUG

Intramuscular injection

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (16)

Alkermes Investigational Site

Little Rock, Arkansas, United States

Alkermes Investigational Site

Rogers, Arkansas, United States

Outcomes

Primary Outcomes

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

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.

Time frame: Baseline and 4 weeks

Secondary Outcomes

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

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

Time frame: Baseline and 4 weeks

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

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.

Time frame: Baseline and 9 weeks

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

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

Time frame: Baseline and 25 weeks

Data from ClinicalTrials.gov

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