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Assessment of adverse effects in clinical studies of antipsychotic medication: survey of methods used.

BACKGROUNDClinical studies of antipsychotic medication are a primary source of data on the nature of, and relative liability for, adverse effects, relevant to prescribing decisions in clinical practice. AIMSTo identify how safety and tolerability data were collected and reported in recent clinical s... Full description

Journal Title: The British journal of psychiatry : the journal of mental science July 2010, Vol.197(1), pp.67-72
Main Author: Pope, Alison
Other Authors: Adams, Clive , Paton, Carol , Weaver, Tim , Barnes, Thomas R E
Format: Electronic Article Electronic Article
Language: English
Subjects:
ID: E-ISSN: 1472-1465 ; DOI: 10.1192/bjp.bp.109.070961
Link: http://search.proquest.com/docview/733569051/?pq-origsite=primo
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title: Assessment of adverse effects in clinical studies of antipsychotic medication: survey of methods used.
format: Article
creator:
  • Pope, Alison
  • Adams, Clive
  • Paton, Carol
  • Weaver, Tim
  • Barnes, Thomas R E
subjects:
  • Antipsychotic Agents–Adverse Effects
  • Basal Ganglia Diseases–Chemically Induced
  • Controlled Clinical Trials As Topic–Diagnosis
  • Dyskinesia, Drug-Induced–Methods
  • Humans–Diagnosis
  • Research Design–Etiology
  • Severity of Illness Index–Drug Effects
  • Weight Gain–Drug Effects
  • Antipsychotic Agents
ispartof: The British journal of psychiatry : the journal of mental science, July 2010, Vol.197(1), pp.67-72
description: BACKGROUNDClinical studies of antipsychotic medication are a primary source of data on the nature of, and relative liability for, adverse effects, relevant to prescribing decisions in clinical practice. AIMSTo identify how safety and tolerability data were collected and reported in recent clinical studies of antipsychotics. METHODA survey was conducted of all 167 eligible studies published between 2002 and 2007 on the Cochrane Schizophrenia Group register. RESULTSExtrapyramidal side-effects (EPS) and weight gain were most frequently assessed. A minority of reports addressed metabolic abnormalities, aversive subjective experiences and sexual dysfunction. Published rating scales were frequently used to evaluate EPS, but systematic methods were rarely applied to other treatment-emergent problems. The definition of individual adverse effects and the manner of reporting were inconsistent. CONCLUSIONSThe way in which safety and tolerability data are collected and reported in clinical studies does not allow for fair and meaningful comparison of the relative risk profiles of individual antipsychotic drugs.
language: eng
source:
identifier: E-ISSN: 1472-1465 ; DOI: 10.1192/bjp.bp.109.070961
fulltext: fulltext
issn:
  • 14721465
  • 1472-1465
url: Link


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titleAssessment of adverse effects in clinical studies of antipsychotic medication: survey of methods used.
creatorPope, Alison ; Adams, Clive ; Paton, Carol ; Weaver, Tim ; Barnes, Thomas R E
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identifierE-ISSN: 1472-1465 ; DOI: 10.1192/bjp.bp.109.070961
subjectAntipsychotic Agents–Adverse Effects ; Basal Ganglia Diseases–Chemically Induced ; Controlled Clinical Trials As Topic–Diagnosis ; Dyskinesia, Drug-Induced–Methods ; Humans–Diagnosis ; Research Design–Etiology ; Severity of Illness Index–Drug Effects ; Weight Gain–Drug Effects ; Antipsychotic Agents
descriptionBACKGROUNDClinical studies of antipsychotic medication are a primary source of data on the nature of, and relative liability for, adverse effects, relevant to prescribing decisions in clinical practice. AIMSTo identify how safety and tolerability data were collected and reported in recent clinical studies of antipsychotics. METHODA survey was conducted of all 167 eligible studies published between 2002 and 2007 on the Cochrane Schizophrenia Group register. RESULTSExtrapyramidal side-effects (EPS) and weight gain were most frequently assessed. A minority of reports addressed metabolic abnormalities, aversive subjective experiences and sexual dysfunction. Published rating scales were frequently used to evaluate EPS, but systematic methods were rarely applied to other treatment-emergent problems. The definition of individual adverse effects and the manner of reporting were inconsistent. CONCLUSIONSThe way in which safety and tolerability data are collected and reported in clinical studies does not allow for fair and meaningful comparison of the relative risk profiles of individual antipsychotic drugs.
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abstractBACKGROUNDClinical studies of antipsychotic medication are a primary source of data on the nature of, and relative liability for, adverse effects, relevant to prescribing decisions in clinical practice. AIMSTo identify how safety and tolerability data were collected and reported in recent clinical studies of antipsychotics. METHODA survey was conducted of all 167 eligible studies published between 2002 and 2007 on the Cochrane Schizophrenia Group register. RESULTSExtrapyramidal side-effects (EPS) and weight gain were most frequently assessed. A minority of reports addressed metabolic abnormalities, aversive subjective experiences and sexual dysfunction. Published rating scales were frequently used to evaluate EPS, but systematic methods were rarely applied to other treatment-emergent problems. The definition of individual adverse effects and the manner of reporting were inconsistent. CONCLUSIONSThe way in which safety and tolerability data are collected and reported in clinical studies does not allow for fair and meaningful comparison of the relative risk profiles of individual antipsychotic drugs.
doi10.1192/bjp.bp.109.070961
urlhttp://search.proquest.com/docview/733569051/
issn00071250
date2010-07-01