Research
Print page Print page
Switch language
The Capital Region of Denmark - a part of Copenhagen University Hospital
Published

Is it possible to evaluate true prophylactic efficacy of antidepressants in severely ill patients with recurrent depression? Lessons from a placebo-controlled trial. The fifth trial of the Danish University Antidepressant Group (DUAG-5)

Research output: Contribution to journalJournal articleResearchpeer-review

  1. Hypomania/Mania by DSM-5 definition based on daily smartphone-based patient-reported assessments

    Research output: Contribution to journalJournal articleResearchpeer-review

  2. Socio-demographic and clinical risk factors of treatment-resistant depression: A Danish population-based cohort study

    Research output: Contribution to journalJournal articleResearchpeer-review

  3. Is cesarean section a cause of affective disorders?-A national cohort study using sibling designs

    Research output: Contribution to journalJournal articleResearchpeer-review

  1. Transcranial pulsed electromagnetic fields for treatment-resistant depression: A multicenter 8-week single-arm cohort study

    Research output: Contribution to journalJournal articleResearchpeer-review

  2. Dynamic LED-light versus static LED-light for depressed inpatients: study protocol for a randomised clinical study

    Research output: Contribution to journalJournal articleResearchpeer-review

  3. Dynamic LED light versus static LED light for depressed inpatients: results from a randomized feasibility trial

    Research output: Contribution to journalJournal articleResearchpeer-review

  4. Per Bech 12.1.1942-9.5.2018 In Memoriam

    Research output: Contribution to journalJournal articleResearchpeer-review

View graph of relations

BACKGROUND: We compared citalopram and clomipramine against placebo with respect to recurrence prevention as opposed to relapse prevention in patients with recurrent depression, independently of any acute response to the test drug(s).

METHODS: Patients with recurrent depressive disorder with a current depressive episode of moderate to severe degree were recruited over a period of 6.5 years. After 6-15 months of routine open acute and continuation therapy, and a discontinuation/drug-free period of one month following sustained response (at least 3 consecutive monthly ratings with a HAM-D-17-score below 13), patients were randomised under double-blind conditions, with a follow-up period of 2 years. The major endpoint was recurrence (HAM-D-17-score of 16 or above).

RESULTS: A total of 307 patients were included in the open phase and 174 patients completed at least 6 months of treatment and achieved sustained response. Out of these, only 59 patients (34%) could be randomised to placebo (n=22), citalopram (n=19) or clomipramine (n=22), with protocol violation and/or non-consent being the major reasons for non-randomisation. There were no between-group differences in outcome; almost half of the randomised patients met the criterion for recurrence.

LIMITATIONS: The size of the randomised sample was considerably smaller than the planned size.

CONCLUSIONS: The high risk of drop out prior to randomisation among the eligible patients was presumably caused by an interaction between the study design and the study population. The findings suggest that long-term trial designs interposing a drug-free period prior to randomisation are not feasible and recommendable in severely ill patients.

Original languageEnglish
JournalJournal of Affective Disorders
Volume148
Issue number2-3
Pages (from-to)286-90
Number of pages5
ISSN0165-0327
DOIs
Publication statusPublished - Jun 2013

    Research areas

  • Antidepressive Agents, Citalopram, Clomipramine, Denmark, Depressive Disorder, Double-Blind Method, Feasibility Studies, Female, Follow-Up Studies, Humans, Male, Middle Aged, Placebos, Secondary Prevention, Severity of Illness Index, Treatment Outcome, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't

ID: 51788622