Status:
COMPLETED
A Study of Aripiprazole Lauroxil or Paliperidone Palmitate for the Treatment of Schizophrenia
Lead Sponsor:
Alkermes, Inc.
Conditions:
Schizophrenia
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 15 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 12 2019
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT03345979
Start Date
November 15 2017
End Date
March 12 2019
Last Update
August 11 2020
Active Locations (16)
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1
Alkermes Investigational Site
Little Rock, Arkansas, United States, 72211
2
Alkermes Investigational Site
Rogers, Arkansas, United States, 72758
3
Alkermes Investigational Site
Cerritos, California, United States, 90703
4
Alkermes Investigational Site
Culver City, California, United States, 90230