Critical approach to antidepressant trials. Blindness protection is necessary, feasible and measurable.
BACKGROUND
Double-blind placebo-controlled trials are the academic standard for clinical psychopharmacology research.


OBJECTIVE
To identify the potential defects of current double-blind procedures in trials involving antidepressants and to investigate whether safeguards for blindness protection are used.


METHODS
We reviewed the literature and devised a short seven-item checklist for evaluating the quality of blindness protection. We performed a computerised search for 1998 to identify the placebo-controlled studies that evaluated the efficacy of an antidepressant. The checklist was used to assess all traceable antidepressant trials published in 1998.


RESULTS
Relevant criticisms question the blindness procedures. The available methods which may bolster blindness are very seldom used.


CONCLUSIONS
Improvement in the blindness procedures used for antidepressant trials is necessary, feasible and measurable.
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Clinique des Maladies Mentales et de l'Encéphale, Centre Hospitalier Sainte-Anne, Paris, France.
Siobud-Dorocant
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Dardennes
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D000928:Antidepressive Agents / Q000627:therapeutic use*; D018849:Controlled Clinical Trials as Topic / Q000379:methods*; D003866:Depressive Disorder / Q000188:drug therapy*; D004311:Double-Blind Method; D006801:Humans; D010919:Placebos; D012189:Retrospective Studies
D000928:Antidepressive Agents; D010919:Placebos