title: The effects of centralised and specialised intervention in the early course of severe unipolar depressive disorder: a randomised clinical trial.
abstract: BACKGROUND
  Little is known on whether centralised and specialised combined pharmacological and psychological intervention in the early phase of severe unipolar depression improve prognosis. The aim of the present study was to assess the benefits and harms of centralised and specialised secondary care intervention in the early course of severe unipolar depression.
  
  
  METHODS
  A randomised multicentre trial with central randomisation and blinding in relation to the primary outcome comparing a centralised and specialised outpatient intervention program with standard decentralised psychiatric treatment. The interventions were offered at discharge from first, second, or third hospitalisation due to a single depressive episode or recurrent depressive disorder. The primary outcome was time to readmission to psychiatric hospital. The data on re-hospitalisation was obtained from the Danish Psychiatric Central Register. The secondary and tertiary outcomes were severity of depressive symptoms according to the Major Depression Inventory, adherence to medical treatment, and satisfaction with treatment according to the total score on the Verona Service Satisfaction Scale-Affective Disorder (VSSS-A). These outcomes were assessed using questionnaires one year after discharge from hospital.
  
  
  RESULTS
  A total of 268 patients with unipolar depression were included. There was no significant difference in the time to readmission (unadjusted hazard ratio 0.89, 95% confidence interval 0.60 to 1.32; log rank: χ(2) = 0.3, d.f. = 1, p = 0.6); severity of depressive symptoms (mood disorder clinic: median 21.6, quartiles 9.7-31.2 versus standard treatment: median 20.2, quartiles 10.0-29.8; p = 0.7); or the prevalence of patients in antidepressant treatment (73.9% versus 80.0%, p = 0.2). Centralised and specialised secondary care intervention resulted in significantly higher satisfaction with treatment (131 (SD 31.8) versus 107 (SD 25.6); p<0.001).
  
  
  CONCLUSIONS
  Centralised and specialised secondary care intervention in the early course of severe unipolar depression resulted in no significant effects on time to rehospitalisation, severity of symptoms, or use of antidepressants, but increased patient satisfaction.
  
  
  BACKGROUND
  ClinicalTrials.gov NCT00253071.
authors.affiliation: Mood Disorder Clinic, Psychiatric Centre Copenhagen, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.
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
authors.forename: Lars Vedel
authors.initials: LV
authors.lastname: Kessing
mesh_terms: D000328:Adult; D000928:Antidepressive Agents / Q000008:administration & dosage; D003718:Denmark; D003866:Depressive Disorder / Q000523:psychology / Q000628:therapy*; D005260:Female; D006760:Hospitalization; D006801:Humans; D008875:Middle Aged; D010349:Patient Compliance; D012042:Registries; D012720:Severity of Illness Index; D013997:Time Factors
chemical_list: D000928:Antidepressive Agents