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Preliminary report on antidepressants published
Date:6/10/2009

full recovery was no better in the mirtazapine group than in the placebo group. In addition, it was shown that patients treated with mirtazapine discontinue treatment more often due to side effects (adverse events) than patients treated with placebo or with some of the other antidepressants.

Bupropion: proof of benefit

The search identified 6 trials on bupropion XL (up to 300 mg/d) and the Institute was given access to the complete clinical study reports by the manufacturer, GlaxoSmithKline. There was proof of benefit for this agent compared to placebo in acute therapy and in the prevention of relapse into seasonal affective disorder, while on the other hand the data provided no indications of harm. The only antidepressant that was compared with bupropion XL in trials was venlafaxine XR. Bupropion XL showed inferiority to venlafaxine XR in acute therapy. Further information can be found in the executive summary of the preliminary report (see below).

Unpublished data contain the potential for deception

If not all available study data are available, this can lead to a strongly biased assessment. This potential for deception is of fundamental importance to all researchers who systematically assess drugs and other medical technologies. The experience of the Institute shows that voluntary self-commitment cannot be relied upon. The Institute therefore considers it an urgent necessity to make it compulsory by law for study sponsors to register clinical trials before commencement and publish the results soon after study completion. IQWiG's position is described in a second press release.


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Contact: Dr. Anna Sabine Ernst
anna-sabine.ernst@iqwig.de
049-022-135-6850
Institute for Quality and Efficiency in Health Care
Source:Eurekalert

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