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

Alkermes

Status and phase: Completed; Phase 3

Conditions: Schizophrenia

Treatments: Combination Product: Aripiprazole Lauroxil; Drug: Paliperidone Palmitate

Study type: Interventional

Funder types: Industry

Identifiers

NCT03345979

ALK9072-A306

Details and patient eligibility

About

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.

Enrollment: 200 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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200 participants in 2 patient groups

Treatment Group 1

Experimental group

Description:

Regular injections

Treatment:

Combination Product: Aripiprazole Lauroxil

Treatment Group 2

Active Comparator group

Description:

Regular injections

Treatment:

Drug: Paliperidone Palmitate