Generalizability of antidepressant efficacy trials: differences between depressed psychiatric outpatients who would or would not qualify for an efficacy trial.
OBJECTIVE
In recent years the generalizability of antidepressant efficacy trials has been questioned. Central to the question of generalizability is whether there are differences in clinical, demographic, and psychosocial characteristics between patients who would qualify for an antidepressant efficacy trial and those who would not qualify.


METHODS
The authors compared three groups: 123 depressed patients who would qualify for an antidepressant efficacy trial, 289 whose symptom severity was too mild to qualify for an antidepressant efficacy trial, and 187 who would be excluded because they were suicidal or had a comorbid anxiety or substance use disorder.


RESULTS
Compared with patients who would qualify for an antidepressant efficacy trial, patients who would be excluded because of comorbidity or suicidality were a more chronically ill group with more previous episodes, greater psychosocial impairment, and more personality pathology.


CONCLUSIONS
These findings support further caution in generalizing the results from antidepressant efficacy trials to clinical populations.
Zimmerman
Mark
M
Department of Psychiatry and Human Behavior, Brown Medical School, Rhode Island Hospital, Providence, RI 02905, USA. mzimmerman@lifespan.org
Chelminski
Iwona
I
Posternak
Michael A
MA
D000328:Adult; D000553:Ambulatory Care; D000928:Antidepressive Agents / Q000627:therapeutic use*; D002908:Chronic Disease; D002985:Clinical Protocols / Q000592:standards; D002986:Clinical Trials as Topic / Q000592:standards*; D015897:Comorbidity; D003866:Depressive Disorder / Q000175:diagnosis / Q000188:drug therapy* / Q000523:psychology; D005260:Female; D006801:Humans; D008297:Male; D018579:Patient Selection; D010554:Personality Disorders / Q000175:diagnosis / Q000453:epidemiology / Q000523:psychology; D012008:Recurrence; D012720:Severity of Illness Index; D013405:Suicide / Q000523:psychology; D016896:Treatment Outcome
D000928:Antidepressive Agents