I agree with Dr Shepherd that there is a need to better define outcomes in clinical trials. It is correct that we defined recovery as a sustained remission of psychiatric symptoms. Indeed, we followed the definition recommended by the International Society for Bipolar Disorders (ISBD). Reference Tohen, Frank, Bowden, Colom, Ghaemi and Yatham1 The term recovery in the ISBD consensus guidelines is based on sustained absence of or low-severity symptomatology without considering functional outcomes.
Observational studies in bipolar disorder, however, have in fact shown that symptomatic remission is not always accompanied by functional recovery, Reference Tohen, Waternaux and Tsuang2,Reference Tohen, Zarate, Hennen, Khalsa, Strakowski and Gebre-Medhin3 which supports Dr Shepherd's point that symptom resolution is not always followed by improved functional outcomes such as adaptation to the experience.
I agree with Dr Shepherd that functional outcomes allow clinicians to make better treatment decisions that are more patient-centred. Furthermore, in the consideration of regulatory approval around the globe, symptom improvement is the main criterion for a new treatment to get approved. Including functional outcomes in the regulatory approval of pharmacological treatments would be beneficial to patients.
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