BMJ  2004;329:1343-1344 (4 December), doi:10.1136/bmj.329.7478.1343-d

Letter

TADS study raises concerns

The first 150 words of the full text of this article appear below.

EDITOR—We have additional concerns to those raised by Lenzer about the adolescents with depression study (TADS).^{1 2}

TADS consists of two separate randomised studies: a double blind comparison of fluoxetine (109 subjects) with placebo (112), and an unblinded comparison between cognitive behaviour therapy alone (111) and fluoxetine plus cognitive behaviour therapy (107). The lack of patient blinding and placebo control in the latter group is likely to exaggerate the benefit seen in the fluoxetine plus cognitive behaviour therapy group, who receive more face to face contact and know (as do their doctors) that they are not receiving placebo.

Comparing results across all four groups is therefore misleading. The authors' claim that a cognitive behaviour therapy plus placebo arm would have been both too expensive and too artificial to have clinical relevance is unconvincing.

TADS found no statistical advantage of fluoxetine over placebo on the primary end point, the children's . . . [Full text of this article]

Department of Psychological Medicine, Women's and Children's Hospital, North Adelaide 5006, Australia jureidinij@wch.sa.gov.au

University of Adelaide, Adelaide 5005, Australia

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Rapid Responses:

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