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 venlafaxine 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.
| Original language | English |
|---|---|
| Pages (from-to) | 251-261 |
| Number of pages | 11 |
| Journal | Clinical Drug Investigation |
| Volume | 28 |
| Issue number | 4 |
| DOIs | |
| Publication status | Published - 2008 Mar 27 |
Fingerprint
Keywords
- Mirtazapine, therapeutic use
- Somatoform disorders
- Venlafaxine, therapeutic use
ASJC Scopus subject areas
- Pharmacology (medical)
- Pharmacology
Cite this
Venlafaxine versus mirtazapine in the treatment of undifferentiated somatoform disorder : A 12-week prospective, open-label, randomized, parallel-group trial. / Han, Changsu; Pae, Chi Un; Lee, Bun Hee; Ko, Young-Hoon; Masand, Prakash S.; Patkar, Ashwin A.; Joe, Sook Haeng; Jung, In Kwa.
In: Clinical Drug Investigation, Vol. 28, No. 4, 27.03.2008, p. 251-261.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Venlafaxine versus mirtazapine in the treatment of undifferentiated somatoform disorder
T2 - A 12-week prospective, open-label, randomized, parallel-group trial
AU - Han, Changsu
AU - Pae, Chi Un
AU - Lee, Bun Hee
AU - Ko, Young-Hoon
AU - Masand, Prakash S.
AU - Patkar, Ashwin A.
AU - Joe, Sook Haeng
AU - Jung, In Kwa
PY - 2008/3/27
Y1 - 2008/3/27
N2 - 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 venlafaxine 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.
AB - 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 venlafaxine 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.
KW - Mirtazapine, therapeutic use
KW - Somatoform disorders
KW - Venlafaxine, therapeutic use
UR - http://www.scopus.com/inward/record.url?scp=40949123518&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=40949123518&partnerID=8YFLogxK
U2 - 10.2165/00044011-200828040-00006
DO - 10.2165/00044011-200828040-00006
M3 - Article
C2 - 18345715
AN - SCOPUS:40949123518
VL - 28
SP - 251
EP - 261
JO - Clinical Drug Investigation
JF - Clinical Drug Investigation
SN - 1173-2563
IS - 4
ER -