title: 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.
abstract: BACKGROUND
  In unipolar, and bipolar affective disorders, there is a high risk of relapse that increases as the number of episodes increases. Naturalistic follow-up studies suggest that the progressive development of the diseases is not prevented with the present treatment modalities. It is not known whether centralised and specialised secondary care intervention initiated early after the onset of the diseases can prevent the progression and thereby improve the prognosis.
  
  
  METHODS
  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 randomization 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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  ClinicalTrials.gov: NCT00253071.
authors.affiliation: Mood Disorder Clinic, Psychiatric Centre Copenhagen, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark. lars.vedel.kessing@regionh.dk
authors.forename: Lars Vedel
authors.initials: LV
authors.lastname: Kessing
authors.forename: Hanne Vibe
authors.initials: HV
authors.lastname: Hansen
authors.forename: Ellen Margrethe
authors.initials: EM
authors.lastname: Christensen
authors.forename: Henrik
authors.initials: H
authors.lastname: Dam
authors.forename: Christian
authors.initials: C
authors.lastname: Gluud
authors.forename: Jørn
authors.initials: J
authors.lastname: Wetterslev
mesh_terms: D000928:Antidepressive Agents / Q000627:therapeutic use*; D001714:Bipolar Disorder / Q000188:drug therapy* / Q000523:psychology; D003131:Combined Modality Therapy; D003866:Depressive Disorder / Q000188:drug therapy* / Q000523:psychology; D006801:Humans; D011613:Psychotherapy; D012107:Research Design; D018401:Sample Size; D012720:Severity of Illness Index
chemical_list: D000928:Antidepressive Agents