A novel approach to measuring response and remission in schizophrenia in clinical trials.

Abstract:

BACKGROUND:Pharmaceutical companies conduct clinical trials to show the efficacy and safety of new medications for the treatment of schizophrenia. After the new medications are marketed, clinicians treating patients with schizophrenia discover that a considerable number of patients do not respond to these new medications. The goals of the review are to examine the methodology and design of recent antipsychotic clinical trials, identify common flaws, and propose guidelines to fix the flaws and improve the quality of future clinical trials of antipsychotic medications. METHODS:A review of recent antipsychotic clinical trials was conducted using a PubMed search. Ten recent trials published in the past four years were reviewed and their methods analyzed and critiqued. RESULTS:The authors identified six major methodological flaws that may explain the suboptimal response in many patients after a drug is approved. Most of the flaws are related to eligibility criteria, the misuse of the Positive and Negative Syndromes Scale (PANSS) and the lack of consensus on how to define remission, response and exacerbation in schizophrenia. Proposed guidelines for a more rigorous use of the PANSS are presented and recommendations are proposed for using uniform criteria for remission, response and exacerbation in schizophrenia. CONCLUSIONS:The authors recommend using standardized diagnostic interviews to screen patients for eligibility criteria and using the PANSS according to the author's recommendations and the proposed guidelines. Uniform criteria to define remission, response and exacerbation are recommended for clinical trials examining the efficacy and safety of antipsychotic drugs in schizophrenia.

journal_name

Schizophr Res

journal_title

Schizophrenia research

authors

Aboraya A,Leucht S,Nasrallah HA,Samara M,Haro JM,Elshazly A,Zangeneh M

doi

10.1016/j.schres.2017.03.020

subject

Has Abstract

pub_date

2017-12-01 00:00:00

pages

123-128

eissn

0920-9964

issn

1573-2509

pii

S0920-9964(17)30139-1

journal_volume

190

pub_type

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