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

NCT03345979Phase 3Completed

Lead sponsor
Alkermes, Inc. (Industry)
Enrollment
200 (actual)
Start date
15 Nov 2017
Primary completion
12 Mar 2019 (actual)
Study completion
12 Mar 2019
Last update posted
11 Aug 2020

Design

Study type
Interventional
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel
Masking
Quadruple
Arms
2

Interventions

  • Aripiprazole Lauroxil Combination product
  • Paliperidone Palmitate Drug

Conditions and primary outcome

  • Schizophrenia

Primary outcome

Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score at Week 4 (Baseline and 4 weeks)

Posted results on ClinicalTrials.gov

Source: ClinicalTrials.gov results for NCT03345979 (opens in a new tab)· Licence: public-domain

First posted · Last update posted · Imported from ClinicalTrials.gov download 2026-10-25

Primary outcomes with a statistical analysis

  1. Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score at Week 4

    Time frame
    Baseline and 4 weeks
    Measure
    Mean
    Unit
    units on a scale

    • Aripiprazole LauroxilSuperiority

      Estimate
      Not given
      CI
      Not given
      p-value
      <.001
      Method
      t-test, 2 sided

    • Paliperidone PalmitateSuperiority

      Estimate
      Not given
      CI
      Not given
      p-value
      <.001
      Method
      t-test, 2 sided

Serious adverse events

Time frame: Adverse event data was collected over 25 weeks.

Participants with serious adverse events per group for NCT03345979, as posted
GroupAffectedAt risk
Aripiprazole Lauroxil899
Paliperidone Palmitate7101

Posted results as ClinicalTrials.gov prints them: primary outcome analyses and serious adverse event totals only. Registry facts, not reviewed by HealthTrade and not investment advice; filing-derived results are listed separately.

Source: ClinicalTrials.gov, U.S. National Library of Medicine. Listing a study does not mean NLM has evaluated it.

Results from company and journal sources

No editor-confirmed results are on record for this study.

Publications

4 on PubMed

  1. Initiating Aripiprazole Lauroxil: Post Hoc Analysis of Safety and Tolerability of 1-Day and 21-Day Regimens.

    The Journal of clinical psychiatry · 2024 Aug 12

    PubMed 39145678 (opens in a new tab)DOI 10.4088/JCP.23m15132 (opens in a new tab)

  2. Safety and Tolerability of Starting Aripiprazole Lauroxil With Aripiprazole Lauroxil NanoCrystal Dispersion in 1 Day Followed by Aripiprazole Lauroxil Every 2 Months Using Paliperidone Palmitate Monthly as an Active Control in Patients With Schizophrenia: A Post Hoc Analysis of a Randomized Controlled Trial.

    The Journal of clinical psychiatry · 2024 Feb 28

    PubMed 38416865 (opens in a new tab)DOI 10.4088/JCP.23m15095 (opens in a new tab)

  3. 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

    PubMed 34625041 (opens in a new tab)DOI 10.1186/s12888-021-03420-x (opens in a new tab)

  4. 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.

    The Journal of clinical psychiatry · 2020 May 19

    PubMed 32433835 (opens in a new tab)DOI 10.4088/JCP.19m13207 (opens in a new tab)

Citations from PubMed, U.S. National Library of Medicine; abstracts are not stored. A publication lists this study’s NCT number and may be a review that cites many studies.

CT-VCA trial quality

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Data integrity

Compare what the registry, company releases, FDA documents and publications say about this study.

Drugs on HealthTrade

Source

Source: ClinicalTrials.gov, U.S. National Library of Medicine. Listing a study does not mean NLM has evaluated it.

Nothing on this page is medical or investment advice.