Skip to main content
×
×
Home

Critical approach to antidepressant trials: Blindness protection is necessary, feasible and measurable

  • C. Even (a1), E. Siobud-Dorocant (a1) and R. M. Dardennes (a1)
Abstract
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.

    • Send article to Kindle

      To send this article to your Kindle, first ensure no-reply@cambridge.org is added to your Approved Personal Document E-mail List under your Personal Document Settings on the Manage Your Content and Devices page of your Amazon account. Then enter the ‘name’ part of your Kindle email address below. Find out more about sending to your Kindle. Find out more about sending to your Kindle.

      Note you can select to send to either the @free.kindle.com or @kindle.com variations. ‘@free.kindle.com’ emails are free but can only be sent to your device when it is connected to wi-fi. ‘@kindle.com’ emails can be delivered even when you are not connected to wi-fi, but note that service fees apply.

      Find out more about the Kindle Personal Document Service.

      Critical approach to antidepressant trials
      Available formats
      ×
      Send article to Dropbox

      To send this article to your Dropbox account, please select one or more formats and confirm that you agree to abide by our usage policies. If this is the first time you use this feature, you will be asked to authorise Cambridge Core to connect with your <service> account. Find out more about sending content to Dropbox.

      Critical approach to antidepressant trials
      Available formats
      ×
      Send article to Google Drive

      To send this article to your Google Drive account, please select one or more formats and confirm that you agree to abide by our usage policies. If this is the first time you use this feature, you will be asked to authorise Cambridge Core to connect with your <service> account. Find out more about sending content to Google Drive.

      Critical approach to antidepressant trials
      Available formats
      ×
Copyright
Corresponding author
Dr C. Even, Clinique des Maladies Mentales et de l'Encéphale, Centre Hospitalier Sainte-Anne, Paris, France
Footnotes
Hide All

Declaration of interest

None.

Footnotes
References
Hide All
Bialik, R. J., Ravindran, A. V., Bakish, D., et al (1995) A comparison of placebo responders and nonresponders in subgroups of depressive disorder. Journal of Psychiatry and Neuroscience, 20, 265270.
Brownell, K. & Stunkard, A. (1982) The double blind in danger: untoward consequences of informed consent. American Journal of Psychiatry, 139, 14871489.
Bystritsky, A. & Waikar, S. V. (1994) Inert placebo versus active medication. Patient blindability in clinical pharmacological trials. Journal of Nervous and Mental Disease, 182, 485487.
Chalmers, T. C., Smith, H., Blackburn, B., et al (1981) A method for assessing the quality of a randomized control trial. Controlled Clinical Trials, 2, 3149.
Engelhardt, D. M., Margolis, R. A., Rudorfer, L., et al (1969) Physician bias and the double-blind. Archives of General Psychiatry, 20, 315320.
Fairchild, C. J., Rush, A. J., Vasavada, N., et al (1986) Which depressions respond to placebo? Psychiatry Research, 18, 217226.
Greenberg, R. P., Bornstein, R. F., Greenberg, M. D., et al (1992) A meta-analysis of antidepressant outcome under ‘blinder$’ conditions. Journal of Consulting and Clinical Psychology, 60, 664669.
Greenberg, R. P., Bornstein, R. F., Zborowski, M. J., et al (1994) A meta-analysis of fluoxetine outcome in the treatment of depression. Journal of Nervous and Mental Disease, 182, 547551.
Healy, D. (1998) Meta-analysis of trials comparing antidepressants with active placebos (commentary). British Journal of Psychiatry, 172, 232234.
Henker, B., Whalen, C. K. & Collins, B. E. (1979) Double-blind and triple-blind assessments of medication and placebo responses in hyperactive children. Journal of Abnormal Child Psychology, 7, 113.
Howard, J., Whittemore, A. S., Hoover, J. J., et al (1982) How blind was the patient blind in AMIS? Clinical Pharmacology and Therapeutics, 32, 543553.
Hughes, J. & Krahn, D. (1985) Blindness and the validity of the double-blind procedure. Journal of Clinical Psychopharmacology, 5, 138142.
Leber, P. D. (1989) Hazards of inference: the active control investigation. Epilepsia, 30, 5763; discussion 64–68.
Margraf, J., Ehlers, A., Roth, W. T., et al (1991) How ‘blind$’ are double-blind studies? Journal of Consulting and Clinical Psychology, 59, 184187.
Moncrieff, J., Wessely, S. & Hardy, R. (1998) Meta-analysis of trials comparing antidepressants with active placebos. British Journal of Psychiatry, 172, 227231.
Muller, H. & Moller, H. J. (1998) Methodological problems in the estimation of the onset of the antidepressant effect. Journal of Affective Disorders, 48, 1523.
Oxtoby, A., Jones, A. & Robinson, M. (1989) Is your ‘double-blind$’ design truly double-blind? British Journal of Psychiatry, 155, 700701.
Rabkin, J., Markowitz, J., Stewart, J., et al (1986) How blind is blind? Assessment of patient and doctor medication guesses in a placebo-controlled trial of imipramine and phenelzine. Psychiatry Research, 19, 7586.
Snyder, S. & Yamamura, H. (1977) Antidepressants and the muscarinic acetylcholine receptor. Archives of General Psychiatry, 2, 236239.
Streiner, D. L. (1995) Learning how to differ: agreement and reliability statistics in psychiatry. Canadian Journal of Psychiatry, 40, 6066.
Thomson, R. (1982) Side effects and placebo amplification. British Journal of Psychiatry, 140, 6468.
White, K., Kando, J., Park, T., et al (1992) Side effects and the ‘blindability$’ of clinical drug trials. American Journal of Psychiatry, 149, 17301731.
Recommend this journal

Email your librarian or administrator to recommend adding this journal to your organisation's collection.

The British Journal of Psychiatry
  • ISSN: 0007-1250
  • EISSN: 1472-1465
  • URL: /core/journals/the-british-journal-of-psychiatry
Please enter your name
Please enter a valid email address
Who would you like to send this to? *
×

Metrics

Altmetric attention score

Full text views

Total number of HTML views: 0
Total number of PDF views: 7 *
Loading metrics...

Abstract views

Total abstract views: 49 *
Loading metrics...

* Views captured on Cambridge Core between 3rd January 2018 - 25th April 2018. This data will be updated every 24 hours.

Critical approach to antidepressant trials: Blindness protection is necessary, feasible and measurable

  • C. Even (a1), E. Siobud-Dorocant (a1) and R. M. Dardennes (a1)
Submit a response

eLetters

No eLetters have been published for this article.

×

Reply to: Submit a response


Your details


Conflicting interests

Do you have any conflicting interests? *