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Safety of patients participating in drug trials

BMJ 1998; 317 doi: (Published 19 September 1998) Cite this as: BMJ 1998;317:818

Use of placebo in trials of drugs for mental illness should be debated

  1. Elizabeth Armstrong, General practitioner
  1. Hyde Park Gate, London SW7 5DZ
  2. Glaxo Wellcome UK, Uxbridge, Middlesex UB11 1BT

    EDITOR—Several advertisements have recently been placed in the national and local press by a private agency, requesting volunteers with manic depression to join a drug trial. This drug trial requires participants to stop all current drug treatment, albeit under psychiatric supervision. They are then randomised to one of three groups, receiving treatment with lithium, lamotrigine (at one of three doses), or placebo for one year.

    This poses three ethical problems. Firstly, advertising publicly for volunteers with serious mental illness is a dubious practice. Secondly, there is evidence that stopping lithium, as required by the trial, results in both relapse and a more severe pattern of illness. 1 2 Thirdly, most participants in the trial will not be treated with an established mood stabilising drug. This would be …

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