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

Phase 3

Completed

Conditions: Schizophrenia

Interventions: Combination Product: Aripiprazole Lauroxil
Drug: Paliperidone Palmitate

Registration Number: NCT03345979

Lead Sponsor: Alkermes, Inc.

Brief 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 200

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment Group 1	Aripiprazole Lauroxil	Regular injections
Treatment Group 2	Paliperidone Palmitate	Regular injections

Primary Outcome Measures

Name	Time	Method
Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score at Week 4	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 Outcome Measures

Name	Time	Method
Least Squares Mean Change in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 4	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
Change in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 9	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.
Change in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 25	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
Least Squares Mean Change in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 9	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
Least Squares Mean Change in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 25	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
Number of Participants With Serious and Non-serious Adverse Events (AEs)	Up to 25 weeks