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Critical approach to antidepressant trials. Blindness protection is necessary, feasible and measurable
C Even1, E Siobud-Dorocant, R M Dardennes
1Clinique des Maladies Mentales et de l'Encéphale, Centre Hospitalier Sainte-Anne, Paris, France.
Background:
Double-blind placebo-controlled trials are the academic standard for clinical psychopharmacology research.
Aims:
To identify the potential defects of current double-blind procedures in trials involving antidepressants and to investigate whether safeguards for blindness protection are used.
Method:
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.
Insights
Double-blind procedures in antidepressant trials have defects. Safeguards to protect blindness are rarely used, indicating a need for improvement in clinical psychopharmacology research.
Area of Science:
- Clinical Psychopharmacology
- Neuroscience Research
Background:
- Double-blind placebo-controlled trials are the gold standard in clinical psychopharmacology.
- Ensuring participant and researcher blindness is critical for trial validity.
Purpose of the Study:
- To identify potential defects in current double-blind procedures for antidepressant trials.
- To investigate the utilization of safeguards for maintaining blindness in these studies.
Main Methods:
- Literature review and development of a seven-item checklist for assessing blindness protection quality.
- Computerized search for 1998 placebo-controlled antidepressant efficacy trials.
- Application of the checklist to evaluate blindness protection in published 1998 trials.
Main Results:
- Criticisms regarding the blindness procedures in antidepressant trials were identified.
- Methods designed to enhance blindness protection are infrequently employed.
Conclusions:
- Improvements in blindness procedures for antidepressant trials are necessary.
- Enhancing blindness protection is feasible and its quality can be measured.