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The Ham D6 is more homogenous and as sensitive as the Ham D17

Published online by Cambridge University Press:  16 April 2020

Y. Lecrubier*
Affiliation:
INSERM U 302, Bâtiment de la Force e Pavillon Clérambault, Hô pital de la Salpêtrière, 47, Boulevard de l'Hôpital, 75013Paris, France
P. Bech
Affiliation:
Psychiatric Research Unit, Frederiksborg General Hospital, Dyrehavevej 48, DK-3400Hilleroed, Denmark
*
*Corresponding author. Tel.: +33 1 42 16 16 55; fax: +33 1 45 85 28 00. E-mail addresses:lecru@ext.jussieu.fr (Y. Lecrubier), pebe@fa.dk (P. Bech).
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Abstract

Objective

Using the data of a positive d.b.c.t. comparing an hypericum extract (W55570) to placebo in depressed patients we explored whether the Ham D6 was unidimentional and in case of a positive answer whether the total score was as sensitive as the total score of the Ham D17.

Methods

The study was a 6 weeks double blind placebo controlled trial comparing 300 mg of hypericum t.i.d (n = 186), to placebo (n = 189), in patients with a single or recurrent depression according to DSM-IV. Superiority of hypericum versus placebo on the main outcome criterion (HDRS 17) was already published.

The unidimensionality of the Hamilton depression scale 6 and 17 items were tested using a Mokken scale analysis. The effect size according to the initial severity of depression was calculated on the ITT last observation carried forward population.

Results

The Ham D6, covering the core symptoms of depression was unidimensional, implying that improving this score reflects a true antidepressant effect. The Ham D17 was not unidimensional.

Hypericum was an effective antidepressant in patients with a pre-treatment score of 12 or more (n = 208) on the Ham D6, the effect size was 0.46. No difference with placebo was observed for those with a score of less than 12 (n = 167).

Conclusions

For the evaluation of an antidepressant effect, because of its specificity and sensitivity, the Ham D6 should be used as a primary outcome measure rather than the Ham D17.

Type
Original article
Copyright
Copyright © Elsevier Masson SAS 2007

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Footnotes

*

The study was supported by lab. Schwabe who produces the WS 5570 Hypericum extract.

References

American Psychiatric Association. Diagnostic and statistical manual of mental disorders. 4th edWashington DC: American Psychiatric Association; 1994. DSM-IV.Google Scholar
Bagby, R.M.Ryder, A.G.Schuller, D.R.Marshall, M.B.The Hamilton Depression Rating Scale: has the gold standard become a lead weight? Am J Psychiatry 2004;161:21632177.CrossRefGoogle ScholarPubMed
Bech, P.The Bech-Rafaelsen Melancholia Scale (MES) in clinical trials of therapies in depressive disorders: a 20-year review of its use as outcome measure. Acta Psychiatr Scand 2002;106:252264.CrossRefGoogle ScholarPubMed
Bech, P.Gram, L.F.Dein, E.Jacobsen, O.Vitger, J.Bolwig, T.G.Quantitative rating of depressive states. Acta Psychiatr Scand 1975;51:161170.CrossRefGoogle ScholarPubMed
Bech, P.Cialdella, P.Haugh, M.Birkett, M.A.Hours, A.Boissel, J.P.et al.A meta-analysis of randomised controlled trials of fluoxetine versus placebo and tricyclic antidepressants in the short-term treatment of major depression. Br J Psychiatry 2000;176:421428.CrossRefGoogle Scholar
Bech, P.Tanghøj, P.Andersen, H.F.Overø, K.Citalopram dose-response revisited using an alternative psychometric approach to evaluate clinical effects of four fixed citalopram doses compared to placebo in patients with major depression. Psychopharmacology 2002;163:2025.CrossRefGoogle ScholarPubMed
Bech, P.Tanghøj, P.Cialdella, P.Andersen, H.F.Pedersen, A.G.Escitalopram dose-response revisited: an alternative psychometric approach to evaluate clinical effects of escitalopram compared to citalopram and placebo in patients with major depression. Int J Neuropsychopharmacol 2004;7:283290.CrossRefGoogle ScholarPubMed
Fava, M.Evins, A.E.Dorer, D.J.Schoenfeld, D.A.The problem of the placebo response in clinical trials for psychiatric disorders: culprits, possible remedies, and a novel study design approach. Psychother Psychosom 2003;72:115127.CrossRefGoogle Scholar
Gastpar, M.Bässler, D.Zella, K.A double-blind, multicentre, placebo-controlled comparison of hypericum Extract STW 3.IV with citalopram in the treatment of moderate depression. Eur Psychiatry 2004;19(Suppl 1):216.Google Scholar
Hamilton, M.A rating scale for depression. J Neurol Neurosurg Psychiatry 1960;23:5662.CrossRefGoogle ScholarPubMed
Healy, D.The antidepressant era. Cambridge: Harvard University Press; 1997.Google Scholar
Hedges, L.V.Olkin, I.Statistical methods for meta-analysis. New York, NY, USA: Academic Press; 1985.Google Scholar
Lecrubier, Y.Sheehan, D.V.Weiller, E.Amorim, P.Bonara, I.Sheehan, K.H.et al.The Mini-International Neuropsychiatric interview (MINI), a short diagnostic structured interview: reliability and validity according to the CIDI. Eur Psychiatry 1997;12:224231.CrossRefGoogle Scholar
Lecrubier, Y.Clerc, G.Didi, R.Kieser, M.Efficacy of St. John's wort extract WS 5570 in major depression: a double-blind, placebo-controlled trial. Am J Psychiatry 2002;159:13611366.CrossRefGoogle ScholarPubMed
Mokken, R.J.A theory and procedure of scale analysis. Paris: Mouton; 1971.CrossRefGoogle Scholar
Molenaar, I.W.Debets, P.Sijtsma, K.Hemker, B.T.MSP, a program for Mokken Scale Analysis for Polytomous Items. Groningen: IEC ProGamma; 1994.Google Scholar
Paykel, E.S.Hollyman, J.A.Freeling, P.Sedgewick, P.Predictors of therapeutic benefit from amitriptyline in mild depression: a general practice placebo-controlled trial. J Affect Disord 1988;14:8395.CrossRefGoogle ScholarPubMed
Prien, R.F.Levine, J.Research and methodological issues for evaluating the therapeutic effectiveness of antidepressant drugs. Psychopharmacol Bull 1984;20:250257.Google ScholarPubMed
Sheehan, D.V.Lecrubier, Y.Sheehan, K.H.Amorim, P.Janavs, J.Weiller, E.et al.The Mini-International Neuropsychiatric Interview (M.I.N.I.): the development and validation of a structured diagnostic psychiatric interview for DSM-IV and ICD-10. J Clin Psychiatry 1998;59(Suppl 20):2233 34–57.Google ScholarPubMed
Sijtsma, K.Molenaar, I.W.Introduction to non-parametric item response theory. London: Sage Publications; 2002.CrossRefGoogle Scholar
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