Generalizability of the Results of Efficacy Trials in First-Episode Schizophrenia: Comparisons Between Subgroups of Participants of the European First Episode Schizophrenia Trial (EUFEST)

Han Boter*, Eske M. Derks, W. Wolfgang Fleischhacker, M. Davidson, Rene S. Kahn, EUFEST Study Grp

*Bijbehorende auteur voor dit werk

OnderzoeksoutputAcademicpeer review

17 Citaten (Scopus)
100 Downloads (Pure)


Objective: Most randomized drug trials in schizophrenia exclude patients with such as suicidality or substance use, which may limit the generalizability of the results. We aimed to evaluate the generalizability of the results of these trials in participants of a randomized clinical trial with broad inclusion criteria.

Method: In 50 sites in 14 countries, 498 with first-episode psychosis (DSM-IV nia, schizoaffective disorder, or schizophreniform disorder) were recruited between December 2002 and January 2006 in an open, randomized clinical drug trial with 12 months of follow-up. Baseline characteristics and follow-up data were compared between patients with versus patients without baseline suicidality and/or substance use.

Results: Of the 489 participants with data on baseline suicidality and substance use, 153 (31%) patients were suicidal and/or using substances. Groups differed on only a few of the many baseline characteristics tested: comorbid patients were younger (25.1 vs 26.5 years of age; P

Conclusions: Although it appears that the generalizability of antipsychotic treatment trials in first-episode patients is not seriously affected the exclusion of patients with suicidal symptoms and/or substance use, researchers should be cautious about the exclusion of such patients.

Originele taal-2English
Pagina's (van-tot)58-65
Aantal pagina's8
TijdschriftJournal of Clinical Psychiatry
Nummer van het tijdschrift1
StatusPublished - jan-2010

Citeer dit