Full access

Letters to the Editor

Published Online: 1 October 2009

Maintenance Treatment for Patients With Bipolar Disorder

BETTAHALASOOR S. SOMASHEKAR, M.D., D.P.M., ASHOK KUMAR JAINER, M.D., M.R.C.Psych., and WAJID SHAFI, M.D.Authors Info & Affiliations

Publication: American Journal of Psychiatry

Volume 166, Number 10

https://doi.org/10.1176/appi.ajp.2009.09050700

PDF/EPUB

To the Editor: We read the study by Dr. Suppes et al. (1) with a great deal of interest and wish to raise concerns about the methodology. The authors evaluated the efficacy and safety of the combination of quetiapine with lithium or divalproex relative to monotherapy with lithium or semisodium valproate in maintenance treatment for patients with bipolar I disorder.

Randomized controlled trials are usually cited as the gold standard for detecting the efficacy of results. However, they often can be flawed in design and are not immune to bias.

First, in this study, 1,953 patients received open-label quetiapine. However, only 628 patients were randomly allocated for maintenance treatment. This indicates that only one-third of the patients were selected for maintenance therapy, which raises the possibility of selection bias. In this regard, Healy (2) stated that company sponsored clinical trials invariably recruit samples of convenience, which by definition do not actually sustain extrapolation to normal clinical practice.

Second, the authors used a wide range of exclusion and restricted inclusion criteria, which minimized the generalizability of the results.

Finally, although both arms received active treatment, the authors failed to perform power calculation, and they did not justify the sample size, which is also a requirement of the Consolidated Standards of Reporting Trials guidelines (3) .

We would appreciate clarification of these issues raised.

Footnotes

The authors report no competing interests.

This letter (doi: 10.1176/appi.ajp.2009.09050700) was accepted for publication in July 2009.

References

Suppes T, Vieta E, Liu S, Brecher M, Paulsson B: Maintenance treatment for patients with bipolar I disorder: results from a North American study of quetiapine in combination with lithium or divalproex (trial 127). Am J Psychiatry 2009; 166:476–488

Google Scholar

Healy D: Evidence biased psychiatry? Psychiatr Bull 2001; 25:290–291

Google Scholar

Begg C, Cho M, Eastwood S: Improving the quality of reporting of randomized controlled trials: the CONSORT statement. JAMA 1996; 276:637–639

Google Scholar

Information & Authors

Information

Published In

American Journal of Psychiatry

Volume 166 • Number 10 • October, 2009

Pages: 1185

PubMed: 19797446

History

Published online: 1 October 2009

Published in print: October, 2009

Authors

Details

BETTAHALASOOR S. SOMASHEKAR, M.D., D.P.M.

View all articles by this author

ASHOK KUMAR JAINER, M.D., M.R.C.Psych.

View all articles by this author

WAJID SHAFI, M.D.

Coventry, United Kingdom

View all articles by this author

Metrics & Citations

Metrics

Citations

Export Citations

If you have the appropriate software installed, you can download article citation data to the citation manager of your choice. Simply select your manager software from the list below and click Download.

For more information or tips please see 'Downloading to a citation manager' in the Help menu.

Format	RIS (ProCite, Reference Manager) EndNote BibTex Medlars RefWorks
Direct importt
Citation style
Style

Copy to clipboard
Tips for downloading citations

View Options

View options

PDF/EPUB

View PDF/EPUB

Get Access

Login options

Already a subscriber? Access your subscription through your login credentials or your institution for full access to this article.

Personal login Institutional Login Open Athens login

Purchase Options

Purchase this article to access the full text.

PPV Articles - American Journal of Psychiatry

Not a subscriber?

Subscribe Now / Learn More

PsychiatryOnline subscription options offer access to the DSM-5-TR^® library, books, journals, CME, and patient resources. This all-in-one virtual library provides psychiatrists and mental health professionals with key resources for diagnosis, treatment, research, and professional development.

Need more help? PsychiatryOnline Customer Service may be reached by emailing [email protected] or by calling 800-368-5777 (in the U.S.) or 703-907-7322 (outside the U.S.).

Maintenance Treatment for Patients With Bipolar Disorder

Footnotes

References