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Schizophrenia Bulletin Advance Access published online on January 16, 2008

Schizophrenia Bulletin, doi:10.1093/schbul/sbm143
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© The Author 2008. Published by Oxford University Press on behalf of the Maryland Psychiatric Research Center. All rights reserved. For permissions, please email: journals.permissions@oxfordjournals.org.

Unanswered Questions in Schizophrenia Clinical Trials

John M. Kane1,3 and Stefan Leucht4
2 The Zucker Hillside Hospital, Glen Oaks, New York, NY
3 The Albert Einstein College of Medicine, Bronx, New York, NY
4 Department of Psychiatry and Psychotherapy, Technische Universität München, Munich, Germany

Keywords: schizophrenia / clinical trials / psychopharmacology

The first 150 words of the full text of this article appear below.


The treatment of schizophrenia remains an enormous challenge. Patients with this illness present with a wide variety of signs and symptoms. Response to treatment and illness course vary considerably. At the same time, we do not have the benefit of established neuropathological, neurophysiological, or neurochemical measures to inform phenotypic classification, and as a result we rely on the clinical evaluation of an array of signs and reports of subjective experience in order to establish diagnoses. The care and thoroughness with which the differential diagnostic process is carried out varies enormously from one clinical setting to another and from clinical practice to clinical research. In addition, mental health care is fragmented, and records are often poor or not readily obtainable and as a result gathering an accurate history of previous symptoms, course, treatments utilized, and response (either therapeutic or adverse) can be very difficult. Patients are not generally in a position . . . [Full Text of this Article]


    Choice of Drug
 

    Optimum Dose
 

    How Should Clinicians Measure Response?
 

    How Long Should a Trial of an Antipsychotic be Before it is Viewed as Ineffective?
 

    What Medications Are Most Effective in Treating Severe Agitation?
 

    How Many Treatments Should be Tried Before Initiating a Trial of Clozapine in Treatment Refractory or Poorly Responsive Patients?
 

    Is Polypharmacy Helpful?
 

    What is the Appropriate Duration of Maintenance Treatment in First-Episode Patients?
 

    Can and How Much Should Antipsychotic Dose be Reduced in the Maintenance Phase of Treatment?
 

    To What Extent Can Long-Acting Injectable Medication Reduce Rates of Relapse and Rehospitalization Compared to Usual Care?
 

    How Should Patients Who Relapse Despite Adequate Dosages and Adherence to Medication be Treated?
 

    What is The Best Way to Manage Sleep Abnormalities in Schizophrenia?
 

    How Best Should Negative Symptoms be Treated?
 

    Challenges in the Conduct of Clinical Trials
 

    Conclusions
 
1 To whom correspondence should be addressed; tel: 718 470-8141, fax: 718 343-7739, e-mail: psychiatry@lij.edu.


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