The effects of centralised and specialised combined pharmacological and psychological intervention compared with decentralised and non-specialised treatment in the early course of severe unipolar and bipolar affective disorders - design of two randomised clinical trials

Two randomised clinical multi-centre trials comparing a centralised and specialised outpatient intervention program consisting of combined pharmacological and psychological intervention with standard decentralised psychiatric treatment. Patients discharged from their first, second, or third hospitalisation due to a manic episode or bipolar disorder (trial 1) or to a single depressive episode or recurrent depressive disorder (trial 2) were randomised. Central randomisations for both trials were stratified for the number of hospitalisations and treatment centre. The primary outcome measure for the two trials is time to re-hospitalisation with an affective episode.These trials are the first to evaluate the effect of a centralised and specialised intervention in patients with early severe affective disorders. The trials used a pragmatic design comparing a specialised mood disorder clinic intervention with decentralised, non-specialised standard psychiatric treatment.ClinicalTrials.gov: NCT00253071Affective disorders are associated with a high risk of relapse and the risk of relapse increases as the number of previous episodes increases [1,2]. Many patients do not recover to previous psychosocial function [3,4]. A proportion of patients present with cognitive impairment also during the remitted phase [5-7], and the risk of developing dementia seems increased in the long run [8,9]. It is well documented from randomised clinical trials that the risk of a new episode in bipolar disorder can be reduced significantly by treatment with lithium or other mood stabilizers [10]. In unipolar disorder continued treatment with antidepressants significantly reduces the risk of relapse [11]. Further, the prophylactic effect of medical treatment may be enhanced by psychoeducation or cognitive behavioural therapy in bipolar disorder [12-17] and by cognitive behavioural therapy in unipolar disorder [18-20]. However, results from naturalistic follow up studies suggest that the progressive