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

NCT03345979 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2020-08-11

Study results available
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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.

Conditions

Interventions

COMBINATION_PRODUCT

Aripiprazole Lauroxil

Intramuscular injection; study drug provided using a pre-filled syringe

DRUG

Paliperidone Palmitate

Intramuscular injection

Sponsors & Collaborators

  • Alkermes, Inc.

    lead INDUSTRY

Principal Investigators

  • Sanjeev Pathak, MD · Alkermes, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-15
Primary Completion
2019-03-12
Completion
2019-03-12
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03345979 on ClinicalTrials.gov