Large Sample Size Fallacy in Trials About Antipsychotics for Neuropsychiatric Symptoms in Dementia

Frontiers in Pharmacology
Tessa A HulshofHendrika J Luijendijk

Abstract

A typical antipsychotics for neuropsychiatric symptoms in dementia have been tested in much larger trials than the older conventional drugs. The advantage of larger sample sizes is that negative findings become less likely and the effect estimates more precise. However, as sample sizes increase, the trials also get more expensive and time consuming while exposing more patients to drugs with unknown safety profiles. Moreover, a large sample size might yield a statistically significant effect that is not necessarily clinically relevant. To assess (1) the variation in sample size and sample size calculations of antipsychotic trials in dementia, (2) the size of reported treatment effects and related statistical significance, and (3) general study characteristics that might be related to sample size. We performed a meta-epidemiological study of randomized trials that tested antipsychotics for neuropsychiatric symptoms in dementia. The trials compared conventional or atypical antipsychotics with placebo or another antipsychotic. Two reviewers independently extracted sample size, sample size calculations, reported treatment effects with p-values, and general study characteristics (drug type, trial duration, type of funding). We calcul...Continue Reading

References

Mar 1, 1976·Journal of the American Geriatrics Society·R T Rada, R Kellner
Jan 1, 1986·Acta Psychiatrica Scandinavica. Supplementum·S A AtherM J Stoker
Sep 1, 1982·The American Journal of Psychiatry·R BarnesG Gumbrecht
Jan 1, 1993·International Clinical Psychopharmacology·W CarlyleL Sheldon
Jan 1, 1996·International Psychogeriatrics·S R AuerB Reisberg
Feb 3, 1998·The Journal of Neuropsychiatry and Clinical Neurosciences·A P Auchus, C Bissey-Black
Nov 23, 2000·Neurology·L TeriUNKNOWN Alzheimer's Disease Cooperative Study
Feb 1, 1962·Journal of the American Geriatrics Society·L D HAMILTON, J L BENNETT
Jun 1, 1964·The American Journal of Psychiatry·A A SUGERMANA M ADLERSTEIN
May 28, 2004·BMJ : British Medical Journal·Steven JoffeJane C Weeks
Jan 12, 2005·The Journal of Clinical Psychiatry·Benoit H MulsantBruce G Pollock
Aug 9, 2005·The American Journal of Geriatric Psychiatry : Official Journal of the American Association for Geriatric Psychiatry·Walter G DeberdtAlan Breier
Oct 20, 2005·JAMA : the Journal of the American Medical Association·Lon S SchneiderPhilip Insel
Oct 26, 2005·Dementia and Geriatric Cognitive Disorders·Frans R J VerheyUNKNOWN Olanzapine-Haloperidol in Dementia Study group
Mar 1, 2006·The American Journal of Geriatric Psychiatry : Official Journal of the American Association for Geriatric Psychiatry·Lon S SchneiderPhilip S Insel
Mar 1, 2006·The American Journal of Geriatric Psychiatry : Official Journal of the American Association for Geriatric Psychiatry·Jacobo MintzerLon S Schneider
Aug 15, 2006·The American Journal of Geriatric Psychiatry : Official Journal of the American Association for Geriatric Psychiatry·Pierre N TariotCeleste Williams-Hughes
Feb 24, 2007·Current Alzheimer Research·Kate X ZhongN A Devine
May 8, 2007·European Psychiatry : the Journal of the Association of European Psychiatrists·M RainerW Wick
Jul 20, 2007·Neuropsychopharmacology : Official Publication of the American College of Neuropsychopharmacology·Dilip V JesteKristine Yaffe
Nov 3, 2007·The American Journal of Geriatric Psychiatry : Official Journal of the American Association for Geriatric Psychiatry·Jacobo E MintzerAndy Forbes
May 14, 2009·BMJ : British Medical Journal·Pierre CharlesPhilippe Ravaud
Jan 14, 2010·Nephrology, Dialysis, Transplantation : Official Publication of the European Dialysis and Transplant Association - European Renal Association·Marlies NoordzijKitty J Jager
Sep 18, 2010·International Journal of Geriatric Psychiatry·Robert HowardRichard Gray
Aug 7, 2012·Scandinavian Journal of Caring Sciences·Björn Lantz
Sep 3, 2013·Journal of Graduate Medical Education·Gail M Sullivan, Richard Feinn
Feb 15, 2014·American Journal of Alzheimer's Disease and Other Dementias·Syed H Shabbir, Amy E Sanders
May 3, 2015·Journal of the American Medical Directors Association·Tessa A HulshofHendrika J Luijendijk
Dec 6, 2018·International Journal of Methods in Psychiatric Research·Tessa A HulshofHendrika J Luijendijk

❮ Previous
Next ❯

Citations

Sep 15, 2020·Journal of Alzheimer's Disease : JAD·Toni SaariIlona Hallikainen

❮ Previous
Next ❯

Clinical Trials Mentioned

NCT00287742
NCT01862640
NCT01922258
NCT02992132

Software Mentioned

Stata

Related Concepts

Related Feeds

Antipsychotic Drugs

Antipsychotic drugs are a class of medication primarily used to manage psychosis (including delusions, hallucinations, paranoia or disordered thought), principally in schizophrenia and bipolar disorder. Discover the latest research on antipsychotic drugs here