Mental Health Update

A look at how the FDA influences testing guidelines for bipolar disorder.

Earlier that morning I had attended a series of lectures about the latest research findings in the treatment of bipolar depression. One of the speakers was Dr. Fred Goodwin, author of the textbook Manic Depressive Illness, and arguably the preeminent world authority on bipolar disorder. After the session I talked with Dr. Goodwin and asked him why they used a particular symptom scale in assessing severity of illness and treatment response. He agreed that the scale (called the MADRS) was inadequate, but he said it’s better than the scale that is most often used for recurring Major Depression (the HamD). I asked why not use the scale developed by Dr. Rush (the QIDS-C). Dr Rush is the director of research at UT Southwestern Medical School in Dallas and one of the leading experts in mood disorders. Dr. Goodwin admitted that the QIDS-C would be better – since it includes excess sleep not just lack of sleep as a symptom and since it better assesses the more typical symptoms of bipolar depression like lack of energy and motivation. The problem is he said that the FDA likes the HamD scale. They compromise to allow the MADRS. I then asked “so why not use overall clinical improvement as the primary outcome instead?” Well the FDA prefers the HamD or the MADRS.

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Read more from this blogger: There’s Method to Our Madness