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Cited by 11Treatment of Major DepressionMental Health Treatment and AccessBipolar Disorder and Treatment

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)

Licht, Rasmus W.·2013·Journal of Affective Disorders
DOI 10.1016/j.jad.2012.12.009
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Abstract

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.

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  • Placebo rates are minimal in the most severely depressed patients who are eligible for DBS trials.

    “these rates are minimal in the most severely depressed patients that also are eligible for DBS trials [79].”

    From Deep brain stimulation for depression. (2022) · cites this paper as [79]

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Authors
Licht, R. W.
Affiliations
Aarhus University Hospital (DK)
Corresponding author
Licht, Rasmus W.
ORCID
Licht, Rasmus W.
Venue
Journal of Affective Disorders
Publisher
Elsevier BV
Published
2013-06
Volume
148
Issue
2-3
Pages
286-290
ISSN
0165-0327 (ISSN-L)
DOI
10.1016/j.jad.2012.12.009
OpenAlex
W1965642425
Cited by
11
References
22
Citations by year
2023: 2 · 2022: 2 · 2021: 1 · 2017: 2 · 2016: 1 · 2015: 3
FWCI
0.98
Type
journal article
Language
en
Open access
closed
Licence
www.elsevier.com/tdm/userlicense/1.0/ (tdm)
Locations
  • Journal of Affective Disorders (publishedVersion)
  • PubMed (publishedVersion)
  • Research at the University of Copenhagen (University of Copenhagen) (submittedVersion)
Funders
  • Eli Lilly and Company
  • Pfizer
  • World Health Organization
  • Aarhus Universitetshospital
  • Cilag
Topics
  • Health Sciences › Medicine › Pharmacology › Treatment of Major Depression
  • Social Sciences › Psychology › Social Psychology › Mental Health Treatment and Access
  • Health Sciences › Medicine › Psychiatry and Mental health › Bipolar Disorder and Treatment
Keywords
recurrent depression, antidepressant prophylaxis, citalopram, clomipramine, recurrence prevention, relapse prevention, treatment-resistant depression, trial dropout, drug-free period
MeSH terms
Antidepressive Agents, Clomipramine, Denmark, Depressive Disorder, Double-Blind Method, Feasibility Studies, Female, Follow-Up Studies, Humans, Male, Middle Aged, Placebos, Severity of Illness Index, Citalopram, Treatment Outcome, Secondary Prevention

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