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

Completed · Phase 3

Conditions studied: Schizophrenia

In brief

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.

Key facts

Study ID

NCT03345979

Run by

Alkermes, Inc.

People needed

200

Starts

2017-11-15

Expected to finish

2019-03-12

Last updated by the study team

2020-08-11

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Alkermes Investigational Site — Little Rock, Arkansas, United States
• Alkermes Investigational Site — Rogers, Arkansas, United States
• Alkermes Investigational Site — Cerritos, California, United States
• Alkermes Investigational Site — Culver City, California, United States
• Alkermes Investigational Site — Garden Grove, California, United States
• Alkermes Investigational Site — Lemon Grove, California, United States
• Alkermes Investigational Site — Hialeah, Florida, United States
• Alkermes Investigational Site — Chicago, Illinois, United States
• Alkermes Investigational Site — Hoffman Estates, Illinois, United States
• Alkermes Investigational Site — Flowood, Mississippi, United States
• Alkermes Investigational Site — St Louis, Missouri, United States
• Alkermes Investigational Site — Las Vegas, Nevada, United States
• Alkermes Investigational Site — Berlin, New Jersey, United States
• Alkermes Investigational Site — Austin, Texas, United States
• Alkermes Investigational Site — Garland, Texas, United States
• Alkermes Investigational Site — Richardson, Texas, United States

Full record on ClinicalTrials.gov

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