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What Happened to those Who Were Suicidal in Study 329? And...

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In May 2014, the RIAT team asked GSK what the children who became suicidal in the course of Study 329 have since been told. The consent form says that anyone entering the study would be treated just the way they would be in normal clinical practice. In Study 329, the children taking imipramine were by design force titrated upwards to doses of the order of 300 mg, which is close to double the dose of imipramine given in adult trials by GSK or in normal clinical practice. In normal clinical practice it would be usual to inform somebody who had become suicidal on an SSRI that the treatment had caused their problem.