Pragmatic randomized controlled trial

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Reference no: EM133785550

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"In this pragmatic randomized controlled trial (RCT), patients are randomly assigned to one of two treatment conditions. In the first condition, treatment consists of rTMS combined with CBT and continued antidepressant medication, which will hereafter be referred to as the rTMS arm. In the second condition, treatment consists of a switch from the current antidepressant medication to a tricyclic antidepressant (TCA) or augmentation with lithium or a second-generation antipsychotic, also in combination with CBT. This will be referred to as the medication arm. The trial consists of 8 weeks of unblinded treatment followed by a follow-up of the cohort at four and 6 months from baseline onward. For a subgroup of the patients, an extended follow-up will take place at nine and 12 months from baseline onward to assess effect decay or preservation. See Fig. 1 for the CONSORT flowchart. Patients in the medication arm who did not recover to the medication intervention can receive rTMS after completion of the first 8 weeks of treatment.

Reference no: EM133785550

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