Clinical trial NCT03345979: A Study of Aripiprazole Lauroxil or Paliperidone Palmitate for the Treatment of Schizophrenia
Official title: A Phase 3b, Multicenter, Randomized, Double-blind Study to Evaluate the Efficacy and Safety of Aripiprazole Lauroxil or Paliperidone Palmitate for the Treatment of Schizophrenia in Subjects Hospitalized for Acute Exacerbation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Schizophrenia
Keywords: Alkermes
schizophrenia
aripiprazole lauroxil
ARISTADA
ARISTADA INITIO
Lead sponsor: Alkermes, Inc.
Sponsor class: INDUSTRY
First posted: 2017-11-17
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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

Primary outcomes:
measure: Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score at Week 4
timeFrame: Baseline and 4 weeks
Secondary outcomes:
measure: Least Squares Mean Change in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 4
timeFrame: Baseline and 4 weeks
measure: Change in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 9
timeFrame: Baseline and 9 weeks
measure: Change in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 25
timeFrame: Baseline and 25 weeks
measure: Least Squares Mean Change in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 9
timeFrame: Baseline and 9 weeks
measure: Least Squares Mean Change in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 25
timeFrame: Baseline and 25 weeks
measure: Number of Participants With Serious and Non-serious Adverse Events (AEs)
timeFrame: Up to 25 weeks
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Alkermes Investigational Site
state: Arkansas
city: Rogers
country: United States
facility: Alkermes Investigational Site
state: Arkansas
city: Cerritos
country: United States
facility: Alkermes Investigational Site
state: California
city: Culver City
country: United States
facility: Alkermes Investigational Site
state: California
city: Garden Grove
country: United States
facility: Alkermes Investigational Site
state: California
city: Lemon Grove
country: United States
facility: Alkermes Investigational Site
state: California
city: Hialeah
country: United States
facility: Alkermes Investigational Site
state: Florida
city: Chicago
country: United States
facility: Alkermes Investigational Site
state: Illinois
city: Hoffman Estates
country: United States
facility: Alkermes Investigational Site
state: Illinois
city: Flowood
country: United States
facility: Alkermes Investigational Site
state: Mississippi
city: Saint Louis
country: United States
facility: Alkermes Investigational Site
state: Missouri
city: Las Vegas
country: United States
facility: Alkermes Investigational Site
state: Nevada
city: Berlin
country: United States
facility: Alkermes Investigational Site
state: New Jersey
city: Austin
country: United States
facility: Alkermes Investigational Site
state: Texas
city: Garland
country: United States
facility: Alkermes Investigational Site
state: Texas
city: Richardson
country: United States
facility: Alkermes Investigational Site
state: Texas
Study officials:
affiliation: Alkermes, Inc.
name: Sanjeev Pathak, MD
role: STUDY_DIRECTOR
References:
citation: Nasrallah HA, Weiden PJ, Walling DP, Du Y, Yao B, Yagoda S, Claxton A. Aripiprazole lauroxil 2-month formulation with 1-day initiation in patients hospitalized for an acute exacerbation of schizophrenia: exploratory efficacy and patient-reported outcomes in the randomized controlled ALPINE study. BMC Psychiatry. 2021 Oct 8;21(1):492. doi: 10.1186/s12888-021-03420-x.
citation: Weiden PJ, Claxton A, Kunovac J, Walling DP, Du Y, Yao B, Yagoda S, Bidollari I, Keane E, Cash E. Efficacy and Safety of a 2-Month Formulation of Aripiprazole Lauroxil With 1-Day Initiation in Patients Hospitalized for Acute Schizophrenia Transitioned to Outpatient Care: Phase 3, Randomized, Double-Blind, Active-Control ALPINE Study. J Clin Psychiatry. 2020 May 19;81(3):19m13207. doi: 10.4088/JCP.19m13207.