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

Changsu Han; Chi Un Pae; Bun Hee Lee; Young Hoon Ko; Prakash S. Masand; Ashwin A. Patkar; Sook Haeng Joe; In Kwa Jung

doi:10.2165/00044011-200828040-00006

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

Changsu Han, Chi Un Pae, Bun Hee Lee, Young Hoon Ko, Prakash S. Masand, Ashwin A. Patkar, Sook Haeng Joe, In Kwa Jung

Research output: Contribution to journal › Article › peer-review

18 Citations (Scopus)

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	https://doi.org/10.2165/00044011-200828040-00006
Publication status	Published - 2008
Externally published	Yes

Bibliographical note

Funding Information:
Dr Han has received research support from the Korea Research Foundation Grant (MOEHRD) [KRF-2007-013-E00033] and from the Korea University Neuropsychiatric Alumni Grant, and has been on the speaker’s bureaux of GlaxoSmithKline Korea, Janssen Pharmaceuticals Korea and Otsuka Korea. Dr Pae has received research grants from GlaxoSmithKline Korea, GlaxoSmithKline, AstraZeneca Korea, Janssen Pharmaceuticals Korea, Eli Lilly and Company Korea, the Korean Research Foundation, Otsuka Korea, Wyeth Korea and the Korean Institute of Science and Technology Evaluation and Planning, and has received honoraria from/is on the speaker’s bureaux of GlaxoSmithKline Korea, Lundbeck Korea, AstraZeneca Korea, Janssen Pharmaceuticals Korea, Eli Lilly and Company Korea, McNeil Consumer and Specialty Inc. and Otsuka Korea. Dr Patkar is a consultant for Bristol-Myers Squibb, GlaxoSmithKline and Reckitt Benckiser, is on the speaker’s bureaux of Bristol-Myers Squibb, GlaxoSmithKline and Reckitt Benckiser, and has received research support from the National Institutes of Health, AstraZeneca, Bristol-Myers Squibb, Forest Laboratories Inc., GlaxoSmithKline, Janssen, McNeil Consumer and Specialty Inc., Organon, Jazz Pharmaceuticals and Pfizer. Dr Masand is a consultant for Bristol-Myers Squibb Company, Cephalon Inc., Eli Lilly and Company, Forest Laboratories Inc., GlaxoSmithKline, i3CME, Janssen Pharmaceutica, Jazz Pharmaceuticals, Organon, Pfizer Inc., Targacept Inc. and Wyeth Pharmaceuticals, is on the speaker’s bureaux of Astra-Zeneca, Bristol Myers Squibb Company, Forest Laboratories Inc., GlaxoSmithKline, Janssen Pharmaceutica, Pfizer Inc. and Wyeth Pharmaceuticals, and has received research support from AstraZeneca, Bristol-Myers Squibb Company, Cephalon Inc., Eli Lilly and Company, Forest Laboratories Inc., GlaxoSmithKline, Ortho McNeil Pharmaceutical, Inc., Janssen Pharmaceutica and Wyeth Pharmaceuticals. The other authors have no conflicts of interest that are directly relevant to the content of this study, and no funding was provided for this study.

Keywords

Mirtazapine, therapeutic use
Somatoform disorders
Venlafaxine, therapeutic use

ASJC Scopus subject areas

Pharmacology (medical)

Access to Document

10.2165/00044011-200828040-00006

Cite this

@article{df7d314165f54ed384a3bb51c67bd1e1,

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

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.",

keywords = "Mirtazapine, therapeutic use, Somatoform disorders, Venlafaxine, therapeutic use",

author = "Changsu Han and Pae, {Chi Un} and Lee, {Bun Hee} and Ko, {Young Hoon} and Masand, {Prakash S.} and Patkar, {Ashwin A.} and Joe, {Sook Haeng} and Jung, {In Kwa}",

note = "Funding Information: Dr Han has received research support from the Korea Research Foundation Grant (MOEHRD) [KRF-2007-013-E00033] and from the Korea University Neuropsychiatric Alumni Grant, and has been on the speaker{\textquoteright}s bureaux of GlaxoSmithKline Korea, Janssen Pharmaceuticals Korea and Otsuka Korea. Dr Pae has received research grants from GlaxoSmithKline Korea, GlaxoSmithKline, AstraZeneca Korea, Janssen Pharmaceuticals Korea, Eli Lilly and Company Korea, the Korean Research Foundation, Otsuka Korea, Wyeth Korea and the Korean Institute of Science and Technology Evaluation and Planning, and has received honoraria from/is on the speaker{\textquoteright}s bureaux of GlaxoSmithKline Korea, Lundbeck Korea, AstraZeneca Korea, Janssen Pharmaceuticals Korea, Eli Lilly and Company Korea, McNeil Consumer and Specialty Inc. and Otsuka Korea. Dr Patkar is a consultant for Bristol-Myers Squibb, GlaxoSmithKline and Reckitt Benckiser, is on the speaker{\textquoteright}s bureaux of Bristol-Myers Squibb, GlaxoSmithKline and Reckitt Benckiser, and has received research support from the National Institutes of Health, AstraZeneca, Bristol-Myers Squibb, Forest Laboratories Inc., GlaxoSmithKline, Janssen, McNeil Consumer and Specialty Inc., Organon, Jazz Pharmaceuticals and Pfizer. Dr Masand is a consultant for Bristol-Myers Squibb Company, Cephalon Inc., Eli Lilly and Company, Forest Laboratories Inc., GlaxoSmithKline, i3CME, Janssen Pharmaceutica, Jazz Pharmaceuticals, Organon, Pfizer Inc., Targacept Inc. and Wyeth Pharmaceuticals, is on the speaker{\textquoteright}s bureaux of Astra-Zeneca, Bristol Myers Squibb Company, Forest Laboratories Inc., GlaxoSmithKline, Janssen Pharmaceutica, Pfizer Inc. and Wyeth Pharmaceuticals, and has received research support from AstraZeneca, Bristol-Myers Squibb Company, Cephalon Inc., Eli Lilly and Company, Forest Laboratories Inc., GlaxoSmithKline, Ortho McNeil Pharmaceutical, Inc., Janssen Pharmaceutica and Wyeth Pharmaceuticals. The other authors have no conflicts of interest that are directly relevant to the content of this study, and no funding was provided for this study.",

year = "2008",

doi = "10.2165/00044011-200828040-00006",

language = "English",

volume = "28",

pages = "251--261",

journal = "Clinical Drug Investigation",

issn = "1173-2563",

publisher = "Adis International Ltd",

number = "4",

}

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

N1 - Funding Information: Dr Han has received research support from the Korea Research Foundation Grant (MOEHRD) [KRF-2007-013-E00033] and from the Korea University Neuropsychiatric Alumni Grant, and has been on the speaker’s bureaux of GlaxoSmithKline Korea, Janssen Pharmaceuticals Korea and Otsuka Korea. Dr Pae has received research grants from GlaxoSmithKline Korea, GlaxoSmithKline, AstraZeneca Korea, Janssen Pharmaceuticals Korea, Eli Lilly and Company Korea, the Korean Research Foundation, Otsuka Korea, Wyeth Korea and the Korean Institute of Science and Technology Evaluation and Planning, and has received honoraria from/is on the speaker’s bureaux of GlaxoSmithKline Korea, Lundbeck Korea, AstraZeneca Korea, Janssen Pharmaceuticals Korea, Eli Lilly and Company Korea, McNeil Consumer and Specialty Inc. and Otsuka Korea. Dr Patkar is a consultant for Bristol-Myers Squibb, GlaxoSmithKline and Reckitt Benckiser, is on the speaker’s bureaux of Bristol-Myers Squibb, GlaxoSmithKline and Reckitt Benckiser, and has received research support from the National Institutes of Health, AstraZeneca, Bristol-Myers Squibb, Forest Laboratories Inc., GlaxoSmithKline, Janssen, McNeil Consumer and Specialty Inc., Organon, Jazz Pharmaceuticals and Pfizer. Dr Masand is a consultant for Bristol-Myers Squibb Company, Cephalon Inc., Eli Lilly and Company, Forest Laboratories Inc., GlaxoSmithKline, i3CME, Janssen Pharmaceutica, Jazz Pharmaceuticals, Organon, Pfizer Inc., Targacept Inc. and Wyeth Pharmaceuticals, is on the speaker’s bureaux of Astra-Zeneca, Bristol Myers Squibb Company, Forest Laboratories Inc., GlaxoSmithKline, Janssen Pharmaceutica, Pfizer Inc. and Wyeth Pharmaceuticals, and has received research support from AstraZeneca, Bristol-Myers Squibb Company, Cephalon Inc., Eli Lilly and Company, Forest Laboratories Inc., GlaxoSmithKline, Ortho McNeil Pharmaceutical, Inc., Janssen Pharmaceutica and Wyeth Pharmaceuticals. The other authors have no conflicts of interest that are directly relevant to the content of this study, and no funding was provided for this study.

PY - 2008

Y1 - 2008

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

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DO - 10.2165/00044011-200828040-00006

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ER -

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

Abstract

Bibliographical note

Keywords

ASJC Scopus subject areas

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