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

ClinicalTrials.gov ID: NCT03345979

Public ClinicalTrials.gov record NCT03345979. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Oct 17, 2026, 2:57 AM EDT

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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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID: NCT03345979
Recruitment status: Completed
Study type: Interventional
Phase: Phase 3
Lead sponsor: Alkermes, Inc.; Industry
Enrollment: 200 participants

Conditions and interventions

Conditions

Schizophrenia

Interventions

Aripiprazole Lauroxil Combination Product
Paliperidone Palmitate Drug

Combination Product · Drug

Eligibility (public fields only)

Age range: 18 Years to 65 Years
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Nov 15, 2017 (Actual)
Primary completion: Mar 12, 2019 (Actual)
Completion: Mar 12, 2019 (Actual)
Last update posted: Aug 11, 2020

2017 – 2019

United States locations

U.S. sites: 16
U.S. states: 9
U.S. cities: 16

Facility	City	State	ZIP	Site status
Alkermes Investigational Site	Little Rock	Arkansas	72211	—
Alkermes Investigational Site	Rogers	Arkansas	72758	—
Alkermes Investigational Site	Cerritos	California	90703	—
Alkermes Investigational Site	Culver City	California	90230	—
Alkermes Investigational Site	Garden Grove	California	92845	—
Alkermes Investigational Site	Lemon Grove	California	91945	—
Alkermes Investigational Site	Hialeah	Florida	33012	—
Alkermes Investigational Site	Chicago	Illinois	60640	—
Alkermes Investigational Site	Hoffman Estates	Illinois	60169	—
Alkermes Investigational Site	Flowood	Mississippi	39232	—
Alkermes Investigational Site	St Louis	Missouri	63141	—
Alkermes Investigational Site	Las Vegas	Nevada	89102	—
Alkermes Investigational Site	Berlin	New Jersey	08009	—
Alkermes Investigational Site	Austin	Texas	78754	—
Alkermes Investigational Site	Garland	Texas	75042	—
Alkermes Investigational Site	Richardson	Texas	75080	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT03345979, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Aug 11, 2020 · Synced Oct 17, 2026

Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT03345979 live on ClinicalTrials.gov.

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