How to Interpret Findings
Concerning Newly Approved Antipsychotic Agents:
Clinical Implications of the Lurasidone PEARL 2 Study

This InfoPack presents the compilation of a detailed panel discussion on the results of the Program to Evaluate the Antipsychotic Response to Lurasidone (PEARL 2) study, a well-designed registration study that included an active control. The goal of the InfoPack is to help clinicians better understand how to translate data from pivotal antipsychotic trials into useful information for managing specific patients in general clinical settings.

As part of the discussion, the panel considered the following questions:

  • What are key unmet needs in terms of available antipsychotics?
  • What key outcomes should be considered in evaluating findings from clinical trials of new antipsychotics?
  • What are considerations when evaluating the results of trials that include active controls for assay sensitivity? How do such studies differ from those that use noninferiority designs to compare the efficacy of 2 or more active agents?

Online InfoPack Materials

Multimedia InfoPack

An interactive online version of the InfoPack including animated graphics that bring the data to life

PDF Reprint of the PEARL 2 Study

Read the original article featured in this InfoPack
(Am J Psychiatry 2011;168(9):957–967)

InfoPack PDF

A printer-friendly online version of the InfoPack just as it was printed

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Faculty Presenters

  • Christoph U. Correll, MD (Chair)
  • The Zucker Hillside Hospital, Glen Oaks
    Hofstra North Shore-LIJ School of Medicine, Hempstead
    Albert Einstein College of Medicine, New York
    New York
  • John Lauriello, MD
  • The University of
    Missouri and the
    University of Missouri
    Psychiatric Center


  • Ashok Malla, MD
  • McGill University
    Douglas Institute
    Montreal, Quebec, Canada
  • Jonathan M. Meyer, MD
  • University of California
    at San Diego
    Loma Linda University, Loma Linda



Faculty Disclosure

In the spirit of full disclosure, the faculty were asked to complete a statement regarding all relevant personal and financial relationships between themselves or their spouse/partner and any commercial interest. Faculty financial disclosures are as follows:

Dr Correll is a consultant for Alexza, AstraZeneca, Biotis, Bristol-Myers Squibb, Desitin, Eli Lilly, IntraCellular Therapies, Lundbeck, MedAvante, Pfizer, Otsuka, Takeda, and Teva; has received grant/research support from Bristol-Myers Squibb, Otsuka, Janssen, Johnson & Johnson, the National Institute of Mental Health, NARSAD, and the Feinstein Institute for Medical Research; has received honoraria from Bristol-Myers Squibb, Cephalon, GlaxoSmithKline, Janssen, Johnson & Johnson, MedScape, Otsuka, ProPhase, Takeda, and Teva; is a member of the speakers/advisory boards for Actelion, Alexza, AstraZeneca, Bristol-Myers Squibb, IntraCellular Therapies, MedAvante, Merck, Novartis, Otsuka, Pfizer, and Sunovion; and is a stock shareholder in Alexza.

Dr Lauriello is a consultant for Janssen, has received grant/research support from Sunovion, and is a member of the advisory board for Otsuka.

Dr Malla has received grant/research support from Janssen-Ortho (Canada), Bristol-Myers Squibb, Pfizer, and AstraZeneca; has received honoraria from Janssen-Ortho, Bristol-Myers Squibb, and Pfizer; and is a member of the speakers/advisory boards for Sunovion, Lundbeck, Pfizer, and Bristol-Myers Squibb.

Dr Meyer is a member of the speakers/advisory boards for Arbor Scientia, AstraZeneca, Bristol-Myers Squibb, Janssen, Neuroscience Education Institute, Novartis, Merck, Pfizer, and Sunovion.


This InfoPack is based on a roundtable discussion by 4 experts on the treatment of schizophrenia held November 1, 2011. This evidence-based, peer-reviewed InfoPack was prepared by Healthcare Global Village, Inc. Financial support for preparation and dissemination of this InfoPack was provided by Sunovion Pharmaceuticals, Inc. The authors acknowledge Ruth Ross, Project Manager, Healthcare Global Village, Inc., for project management and editorial assistance in developing the manuscript. The opinions expressed herein are those of the authors and do not necessarily reflect the views of Healthcare Global Village, Inc., the publisher, the American Society of Clinical Psychopharmacology, or the commercial supporter.

Review Process

The faculty for this InfoPack discussed the content in a peer-review planning teleconference, the chair and faculty reviewed the InfoPack for accuracy, and a member of the Journal Editorial Board who is without conflict of interest reviewed the InfoPack to determine whether the material is evidence-based and objective.

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