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Venlafaxine versus mirtazapine in the treatment of undifferentiated somatoform disorder - A 12-week prospective, open-label, randomized, parallel-group trial

Authors
Han, ChangsuPae, Chi-UnLee, Bun-HeeKo, Young-HoonMasand, Prakash S.Patkar, Ashwin A.Joe, Sook-HaengJung, In-Kwa
Issue Date
2008
Publisher
ADIS INT LTD
Keywords
Mirtazapine, therapeutic use; Somatoform disorders; Venlafaxine, therapeutic use
Citation
CLINICAL DRUG INVESTIGATION, v.28, no.4, pp.251 - 261
Indexed
SCIE
SCOPUS
Journal Title
CLINICAL DRUG INVESTIGATION
Volume
28
Number
4
Start Page
251
End Page
261
URI
https://scholar.korea.ac.kr/handle/2021.sw.korea/125606
DOI
10.2165/00044011-200828040-00006
ISSN
1173-2563
Abstract
Objective: We set out to compare the efficacy and tolerability of mirtazapine versus venlafaxine in patients with undifferentiated somatoform disorder (USD) using the Patient Health Questionnaire-15 (PHQ-15). Methods: This was a 12-week prospective, open-label, randomized, parallel-group trial. The trial consisted of six visits that included baseline and weeks 1, 2, 4, 8 and 12. The primary effectiveness measure was the mean change in PHQ-15 total score from baseline to the end of treatment. Secondary effectiveness measures included the mean changes in total scores on the Beck Depression Inventory (BDI) and the 12-item General Health Questionnaire (GHQ) from baseline to the end of treatment. Ninety-five subjects were randomized to either mirtazapine (n =50) or venlafaxine (n = 45); 71 subjects completed the study (mirtazapine: n=39/50 [78%]; venlafaxine: n = 32/45 [71%]). Results: The mean total score on the PHQ-15 decreased by 34.7% (-8.4, p < 0.0001) from baseline to endpoint in the mirtazapine group and by 26.6% (-6.1, p < 0.0001) in the venlafaxine group. A marginally significant between-group difference was observed for the mean change in total score on the PHQ-15 from baseline to endpoint (F = 4.126, p = 0.046). The mean total scores on the GHQ-12 and BDI from baseline to endpoint decreased by -4.9 (29.4%, p < 0.0001) and -13.5 (55.9%, p < 0.0001), respectively, in the mirtazapine group, and by -4.3 (26.2%, p = 0.001) and -9.02 (46.0%, p < 0.0001), respectively, in the venlataxine group. No between-group difference was observed for the mean changes in total scores on the secondary effectiveness measures from baseline to endpoint. Both treatments were well tolerated. Conclusion: Our findings suggest that both mirtazapine and venlafaxine may be effective and well tolerated in the treatment of patients with USD. Double-blind, placebo-controlled and/or head-to-head comparison studies are required to allow definite conclusions to be drawn.
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