Pharmacopsychiatry 2003; 36(6): 313-316
DOI: 10.1055/s-2003-45120
Original Paper
© Georg Thieme Verlag Stuttgart · New York

The Validity of the Depression Rating Scales in Discriminating between Citalopram and Placebo in Depression Recurrence in the Maintenance Therapy of Elderly Unipolar Patients with Major Depression

J. Bent-Hansen1 , M. Lunde2 , R. Klysner1 , M. Andersen3 , P. Tanghøj2 , K. Solstad1 , P. Bech2
  • 1Psychiatric Research Clinic, Frederiksberg Hospital
  • 2Psychiatric Research Unit, Frederiksborg General Hospital
  • 3H. Lundbeck A/S, International Clinical Research
Further Information

Publication History

Received: 27.8.2002 Revised: 6.11.2002

Accepted: 28.11.2002

Publication Date:
09 December 2003 (online)

The World Federation of Societies of Biological Psychiatry guidelines for treatment of unipolar major depression has recommended three depression rating scales for evaluating outcome: The Hamilton Depression Rating Scale (HAM-D), the Montgomery-Asberg Depression Rating Scale (MADRS), and the Bech-Rafaelsen Melancholia Scale (MES). In this study we evaluated the ability of these scales to differentiate between citalopram and placebo in the recurrence prevention of unipolar depression.

The study is a psychometric reexamination of a trial on the efficacy of citalopram versus placebo in the maintenance therapy of elderly patients with unipolar depression. Internal validity (the Cronbach coefficient alpha, the Loevinger coefficient of homogeneity, and factor analysis) of the three scales has been examined to evaluate their unidimensionality. In the outcome analysis for depression recurrence, the conventional cutoff scores of the three scales are used.

In total, 60 patients received citalopram and 61 patients received placebo in the maintenance phase of 48 weeks. The results showed that the internal validity was higher for MES and MADRS than for HAM-D. Using the MADRS, 67.2 % of the patients on placebo and 31.6 % of the patients on citalopram developed a depression recurrence (ratio 2.12); using HAM-D17, 42.6 % on placebo and 13.3 % on citalopram developed a depression recurrence (ratio 3.20); and using the MES, 34.4 % on placebo and 11.7 % on citalopram developed a depression recurrence (ratio 2.94).

The conventional cutoff scores of HAM-D17 and MES for depression recurrence indicated a ratio between citalopram and placebo of around 3, while the conventional cutoff scores of MADRS for depression recurrence indicated a ratio of only around 2. In future trials on the recurrence prevention of unipolar depression, a cutoff score of 25 rather than 22 on the MADRS is recommended.

References

  • 1 American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders. 4th Ed. (DSM-IV). APA, Washington, DC; 1994
  • 2 Bauer M, Whybrow P C, Angst J, Versiani M, Moeller H J. World Federation of Societies of Biological Psychiatry (WFSBP) Guidelines for biological treatment of unipolar depressive disorders.  World J Biol Psychiat. 2002;  3 5-43
  • 3 Bech P. Clinical effects of selective serotonin reuptake inhibitors. In: Dahl SG, Gram LF (eds) Clinical pharmacology in psychiatry Springer Berlin; 1989: 81-93
  • 4 Bech P. The Bech-Rafaelsen Melancholia Scale (MES) in clinical trials of therapies in depressive disorder. A twenty-year review of its use as outcome measure.  Acta Psychiat Scand. 2002;  106 252-264
  • 5 Bech P, Kastrup M, Rafaelsen O J. Mini-compendium of rating scales for states of anxiety, depression, mania, schizophrenia with corresponding DSM-III syndromes.  Acta Psychiat Scand. 1986;  73 (suppl 326) 1-37
  • 6 Bech P, Rafaelsen O J. The use of rating scales exemplified by a comparison of the Hamilton and the Bech-Rafaelsen Melancholia Scale.  Acta Psychiat Scand. 1980;  62 (suppl 285 128-132
  • 7 Faries D, Herrera J, Rayamajhi J, Debrota D, Demitrack M, Potter W Z. The responsiveness of the Hamilton Depression Rating Scale.  J Psychiat Res. 2000;  34 3-10
  • 8 Flint A J, Rifat S L. Recurrence of first-episode geriatric depression after discontinuation of maintenance antidepressants.  Am J Psychiat. 1999;  56 943-945
  • 9 Hamilton M. Development of a rating sale for primary depressive illness.  Br J Soc Clin Psychol. 1967;  6 278-296
  • 10 Hamilton M, Shapiro C M. Depression. In: Peck DF, Shapiro CM (eds) Measuring human problems. Chichester: Wiley 1990: 25-65
  • 11 Klysner R, Bent-Hansen J, Hansen H L, Lunde M, Pleidrup E, Poulsen D L, Andersen M, Petersen H E. The efficacy of citalopram in the prevention of recurrent depression in elderly patients: A placebo-controlled study on maintenance therapy.  Br J Psychiat. 2002;  181 29-35
  • 12 Kørner A, Nielsen B M, Eschen F. Quantifying depressive symptomatology: inter-rater reliability and inter-item correlation.  J Affect Disord. 1990;  20 143-149
  • 13 Kurzthaler I, Hotter A, Miller C, Kemmler G, Halder W, Rhomberg H P, Fleischhacker W. Risk profile of SSrIs in elderly depressive patients with co-morbid physical illness.  Pharmacopsychiatry. 2001;  34 114-118
  • 14 Mokken R J. A theory and procedure of scale analysis. Paris; Mouton 1971
  • 15 Montgomery S A. Clinically relevant effect sizes in depression.  Eur Neuropsychopharmacol. 1994;  4 283-284
  • 16 Montgomery S A, Åsberg M. A new depression scale designed to be sensitive to change.  Br J Psychiat. 1979;  134 382-389
  • 17 Nunnally J C, Bernstein I H. Psychometric theory. Third edition New York; McGraw-Hill 1994

Per Bech, M.D.

Professor of Psychiatry

WHO Collaborating Center for Mental Health

Psychiatric Research Unit

Frederiksborg General Hospital

48, Dyrehavevej

DK-3400 Hillerød

Phone: +45 48 29 32 53

Fax: +45 48 26 33 77

Email: pebe@fa.dk

    >