title: Relapse Prevention in Major Depressive Disorder After Successful Acute Electroconvulsive Treatment: a 6-month Double-blind Comparison of Three Fixed Dosages of Escitalopram and a Fixed Dose of Nortriptyline - Lessons from a Failed Randomised Trial of the Danish University Antidepressant Group (DUAG-7).
abstract: BACKGROUND
  Electroconvulsive treatment (ECT) is an effective treatment for severe depression but carries a risk of relapse in the following months.
  
  
  METHODS
  Major depressive disorder patients in a current episode attaining remission from ECT (17-item Hamilton Depression Rating Scale (HAM-D17) score≤9) received randomly escitalopram 10 mg, 20 mg, 30 mg or nortriptyline 100 mg as monotherapies and were followed for 6 months in a multicentre double-blind set-up. Primary endpoint was relapse (HAM-D17≥16).
  
  
  RESULTS
  As inclusion rate was low the study was prematurely stopped with only 47 patients randomised (20% of the planned sample size). No statistically significant between-group differences could be detected. When all patients receiving escitalopram were compared with those receiving nortriptyline, a marginal superiority of nortriptyline was found (p=0.08). One third of patients relapsed during the study period, and one third completed.
  
  
  CONCLUSIONS
  Due to small sample size, no valid efficacy inferences could be made. The outcome was poor, probably due to tapering off of non-study psychotropic drugs after randomisation; this has implications for future study designs. ClinicalTrials.gov Identifier: NCT00660062.
authors.affiliation: Intensive Outpatient Unit for Affective Disorders (IAA), Psychiatric Center Copenhagen, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.
authors.forename: K
authors.initials: K
authors.lastname: Martiny
authors.affiliation: Department of Affective Disorders Mood Disorders Research Unit, Aarhus University Hospital, Aarhus, Denmark.
authors.forename: E R
authors.initials: ER
authors.lastname: Larsen
authors.affiliation: Department of Clinical Medicine, Aalborg University, Aalborg, Denmark.
authors.forename: R W
authors.initials: RW
authors.lastname: Licht
authors.affiliation: Department of Mental Health Services, Esbjerg, Denmark.
authors.forename: C T
authors.initials: CT
authors.lastname: Nielsen
authors.affiliation: Department of Clinical Chemistry & Pharmacology, Odense University Hospital, Odense, Denmark.
authors.forename: P
authors.initials: P
authors.lastname: Damkier
authors.affiliation: Psychiatric Research Unit, Mental Health Centre North Zealand, University of Copenhagen, Copenhagen, Denmark.
authors.forename: E
authors.initials: E
authors.lastname: Refsgaard
authors.affiliation: Psychiatric Research Unit, Mental Health Centre North Zealand, University of Copenhagen, Copenhagen, Denmark.
authors.forename: M
authors.initials: M
authors.lastname: Lunde
authors.affiliation: Psychiatric Research Unit, Mental Health Centre North Zealand, University of Copenhagen, Copenhagen, Denmark.
authors.forename: B
authors.initials: B
authors.lastname: Straasø
authors.affiliation: The Mood Disorder Clinic, Psychiatric Center Copenhagen, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.
authors.forename: E M
authors.initials: EM
authors.lastname: Christensen
authors.affiliation: Department of Psychiatry, Odense University Hospital, Odense, Denmark.
authors.forename: A
authors.initials: A
authors.lastname: Lolk
authors.affiliation: Department of Psychiatry, Odense University Hospital, Odense, Denmark.
authors.forename: J
authors.initials: J
authors.lastname: Holmskov
authors.affiliation: Department of Psychiatry, Odense University Hospital, Odense, Denmark.
authors.forename: C H
authors.initials: CH
authors.lastname: Sørensen
authors.affiliation: Department of Affective Disorders Mood Disorders Research Unit, Aarhus University Hospital, Aarhus, Denmark.
authors.forename: I
authors.initials: I
authors.lastname: Brødsgaard
authors.affiliation: Psychiatric Center Glostrup, Copenhagen University Hospital, Copenhagen, Denmark.
authors.forename: S Z
authors.initials: SZ
authors.lastname: Eftekhari
authors.affiliation: Psychiatric Center Frederiksberg, Copenhagen University Hospital, Copenhagen, Denmark.
authors.forename: B B
authors.initials: BB
authors.lastname: Bendsen
authors.affiliation: Psychiatric Center Frederiksberg, Copenhagen University Hospital, Copenhagen, Denmark.
authors.forename: R
authors.initials: R
authors.lastname: Klysner
authors.affiliation: Psychiatric Center Glostrup, Copenhagen University Hospital, Copenhagen, Denmark.
authors.forename: I M
authors.initials: IM
authors.lastname: Terp
authors.affiliation: Psychiatric Center Gentofte, Copenhagen University Hospital, Copenhagen, Denmark.
authors.forename: J K
authors.initials: JK
authors.lastname: Larsen
authors.affiliation: Department of Affective Disorders Mood Disorders Research Unit, Aarhus University Hospital, Aarhus, Denmark.
authors.forename: P
authors.initials: P
authors.lastname: Vestergaard
authors.affiliation: Department of Affective Disorders Mood Disorders Research Unit, Aarhus University Hospital, Aarhus, Denmark.
authors.forename: P E
authors.initials: PE
authors.lastname: Buchholtz
authors.affiliation: Clinical Pharmacology, Institute of Public Health, University of Southern Denmark, Odense, Denmark.
authors.forename: L F
authors.initials: LF
authors.lastname: Gram
authors.affiliation: Psychiatric Research Unit, Mental Health Centre North Zealand, University of Copenhagen, Copenhagen, Denmark.
authors.forename: P
authors.initials: P
authors.lastname: Bech
mesh_terms: D000328:Adult; D000368:Aged; D000928:Antidepressive Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D015283:Citalopram / Q000008:administration & dosage / Q000627:therapeutic use*; D003865:Major Depressive Disorder / Q000188:drug therapy / Q000517:prevention & control / Q000628:therapy*; D004311:Double-Blind Method; D004565:Electroconvulsive Therapy; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009661:Nortriptyline / Q000008:administration & dosage / Q000627:therapeutic use*; D055502:Secondary Prevention; D016896:Treatment Outcome
chemical_list: D000928:Antidepressive Agents; D015283:Citalopram; D009661:Nortriptyline