Paroxetine for patients with undifferentiated somatoform disorder

A prospective, open-label, 8-week pilot study

Changsu Han, David M. Marks, Chi Un Pae, Bun Hee Lee, Young-Hoon Ko, Prakash S. Masand, Ashwin A. Patkar, In Kwa Jung

Research output: Contribution to journalArticle

1 Citation (Scopus)

Abstract

Background: Forty-eight percent of somatic symptoms encountered in the primary care setting are medically unexplained. Such symptoms have been associated with negative impact on quality of life and with functional impairment. Objective: The aim of this study was to assess the potential utility and tolerability of paroxetine for the treatment of undifferentiated somatoform disorder (USD), using the 15-item Patient Health Questionnaire (PHQ-15) to assess the severity of somatic symptoms. Methods: A prospective, open-label, 8-week pilot study of paroxetine was conducted in outpatients with USD. Data were collected at baseline and at weeks 1, 2, 4, and 8. The primary measure was the mean change in PHQ-15 total score from baseline to the end of treatment. Secondary effectiveness measures included mean changes in total scores on the Beck Depression Inventory (BDI) and the 12-item General Health Questionnaire from baseline to end of treatment. A physical examination, electrocardiography, complete blood count, blood chemistry, urinalysis, and pregnancy test (for women of childbearing potential) were performed at baseline and the end of treatment. Vital signs were measured during each visit. Adverse events (AEs) were recorded during the study and included those determined using the Systematic Assessment for Treatment Emergent Events-General Inquiry. Results: Forty-three Korean patients were screened for the study. Twenty-two patients (13 women, 9 men; mean [SD] age, 37.4 [12.4] years) were enrolled and 20 completed the study; 2 patients were lost to follow-up. The mean total score on the PHQ-15 from baseline to the end of treatment was significantly decreased (17.2 vs 4.3; P = 0.001), as was the mean total BDI score (12.8 vs. 6.3; P < 0.001). Overall, paroxetine was well-tolerated. Nausea and dry mouth were the most commonly reported treatment-emergent AEs (both, 5 [22.7%]); no serious AEs were reported. No abnormal laboratory results were observed. Conclusion: This open-label pilot study found that paroxetine had potential utility in the treatment of USD and was generally well-tolerated. These results suggest that adequately-powered, double-blind, placebo-controlled trials are warranted to more fully assess the efficacy and safety of paroxetine in the treatment of USD.

Original languageEnglish
Pages (from-to)221-231
Number of pages11
JournalCurrent Therapeutic Research - Clinical and Experimental
Volume69
Issue number3
DOIs
Publication statusPublished - 2008 Jun 1

Fingerprint

Paroxetine
Somatoform Disorders
Therapeutics
Depression
Pregnancy Tests
Equipment and Supplies
Urinalysis
Blood Cell Count
Vital Signs
Lost to Follow-Up
Health
Nausea
Physical Examination
Mouth
Primary Health Care
Electrocardiography
Outpatients
Placebos
Quality of Life
Safety

Keywords

  • paroxetine
  • Patient Health Questionnaire
  • pilot study
  • undifferentiated somatoform disorder

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Paroxetine for patients with undifferentiated somatoform disorder : A prospective, open-label, 8-week pilot study. / Han, Changsu; Marks, David M.; Pae, Chi Un; Lee, Bun Hee; Ko, Young-Hoon; Masand, Prakash S.; Patkar, Ashwin A.; Jung, In Kwa.

In: Current Therapeutic Research - Clinical and Experimental, Vol. 69, No. 3, 01.06.2008, p. 221-231.

Research output: Contribution to journalArticle

Han, Changsu ; Marks, David M. ; Pae, Chi Un ; Lee, Bun Hee ; Ko, Young-Hoon ; Masand, Prakash S. ; Patkar, Ashwin A. ; Jung, In Kwa. / Paroxetine for patients with undifferentiated somatoform disorder : A prospective, open-label, 8-week pilot study. In: Current Therapeutic Research - Clinical and Experimental. 2008 ; Vol. 69, No. 3. pp. 221-231.
@article{a1f01ad947254955b235aeadbe549bef,
title = "Paroxetine for patients with undifferentiated somatoform disorder: A prospective, open-label, 8-week pilot study",
abstract = "Background: Forty-eight percent of somatic symptoms encountered in the primary care setting are medically unexplained. Such symptoms have been associated with negative impact on quality of life and with functional impairment. Objective: The aim of this study was to assess the potential utility and tolerability of paroxetine for the treatment of undifferentiated somatoform disorder (USD), using the 15-item Patient Health Questionnaire (PHQ-15) to assess the severity of somatic symptoms. Methods: A prospective, open-label, 8-week pilot study of paroxetine was conducted in outpatients with USD. Data were collected at baseline and at weeks 1, 2, 4, and 8. The primary measure was the mean change in PHQ-15 total score from baseline to the end of treatment. Secondary effectiveness measures included mean changes in total scores on the Beck Depression Inventory (BDI) and the 12-item General Health Questionnaire from baseline to end of treatment. A physical examination, electrocardiography, complete blood count, blood chemistry, urinalysis, and pregnancy test (for women of childbearing potential) were performed at baseline and the end of treatment. Vital signs were measured during each visit. Adverse events (AEs) were recorded during the study and included those determined using the Systematic Assessment for Treatment Emergent Events-General Inquiry. Results: Forty-three Korean patients were screened for the study. Twenty-two patients (13 women, 9 men; mean [SD] age, 37.4 [12.4] years) were enrolled and 20 completed the study; 2 patients were lost to follow-up. The mean total score on the PHQ-15 from baseline to the end of treatment was significantly decreased (17.2 vs 4.3; P = 0.001), as was the mean total BDI score (12.8 vs. 6.3; P < 0.001). Overall, paroxetine was well-tolerated. Nausea and dry mouth were the most commonly reported treatment-emergent AEs (both, 5 [22.7{\%}]); no serious AEs were reported. No abnormal laboratory results were observed. Conclusion: This open-label pilot study found that paroxetine had potential utility in the treatment of USD and was generally well-tolerated. These results suggest that adequately-powered, double-blind, placebo-controlled trials are warranted to more fully assess the efficacy and safety of paroxetine in the treatment of USD.",
keywords = "paroxetine, Patient Health Questionnaire, pilot study, undifferentiated somatoform disorder",
author = "Changsu Han and Marks, {David M.} and Pae, {Chi Un} and Lee, {Bun Hee} and Young-Hoon Ko and Masand, {Prakash S.} and Patkar, {Ashwin A.} and Jung, {In Kwa}",
year = "2008",
month = "6",
day = "1",
doi = "10.1016/j.curtheres.2008.06.004",
language = "English",
volume = "69",
pages = "221--231",
journal = "Current Therapeutic Research - Clinical and Experimental",
issn = "0011-393X",
publisher = "Excerpta Medica",
number = "3",

}

TY - JOUR

T1 - Paroxetine for patients with undifferentiated somatoform disorder

T2 - A prospective, open-label, 8-week pilot study

AU - Han, Changsu

AU - Marks, David M.

AU - Pae, Chi Un

AU - Lee, Bun Hee

AU - Ko, Young-Hoon

AU - Masand, Prakash S.

AU - Patkar, Ashwin A.

AU - Jung, In Kwa

PY - 2008/6/1

Y1 - 2008/6/1

N2 - Background: Forty-eight percent of somatic symptoms encountered in the primary care setting are medically unexplained. Such symptoms have been associated with negative impact on quality of life and with functional impairment. Objective: The aim of this study was to assess the potential utility and tolerability of paroxetine for the treatment of undifferentiated somatoform disorder (USD), using the 15-item Patient Health Questionnaire (PHQ-15) to assess the severity of somatic symptoms. Methods: A prospective, open-label, 8-week pilot study of paroxetine was conducted in outpatients with USD. Data were collected at baseline and at weeks 1, 2, 4, and 8. The primary measure was the mean change in PHQ-15 total score from baseline to the end of treatment. Secondary effectiveness measures included mean changes in total scores on the Beck Depression Inventory (BDI) and the 12-item General Health Questionnaire from baseline to end of treatment. A physical examination, electrocardiography, complete blood count, blood chemistry, urinalysis, and pregnancy test (for women of childbearing potential) were performed at baseline and the end of treatment. Vital signs were measured during each visit. Adverse events (AEs) were recorded during the study and included those determined using the Systematic Assessment for Treatment Emergent Events-General Inquiry. Results: Forty-three Korean patients were screened for the study. Twenty-two patients (13 women, 9 men; mean [SD] age, 37.4 [12.4] years) were enrolled and 20 completed the study; 2 patients were lost to follow-up. The mean total score on the PHQ-15 from baseline to the end of treatment was significantly decreased (17.2 vs 4.3; P = 0.001), as was the mean total BDI score (12.8 vs. 6.3; P < 0.001). Overall, paroxetine was well-tolerated. Nausea and dry mouth were the most commonly reported treatment-emergent AEs (both, 5 [22.7%]); no serious AEs were reported. No abnormal laboratory results were observed. Conclusion: This open-label pilot study found that paroxetine had potential utility in the treatment of USD and was generally well-tolerated. These results suggest that adequately-powered, double-blind, placebo-controlled trials are warranted to more fully assess the efficacy and safety of paroxetine in the treatment of USD.

AB - Background: Forty-eight percent of somatic symptoms encountered in the primary care setting are medically unexplained. Such symptoms have been associated with negative impact on quality of life and with functional impairment. Objective: The aim of this study was to assess the potential utility and tolerability of paroxetine for the treatment of undifferentiated somatoform disorder (USD), using the 15-item Patient Health Questionnaire (PHQ-15) to assess the severity of somatic symptoms. Methods: A prospective, open-label, 8-week pilot study of paroxetine was conducted in outpatients with USD. Data were collected at baseline and at weeks 1, 2, 4, and 8. The primary measure was the mean change in PHQ-15 total score from baseline to the end of treatment. Secondary effectiveness measures included mean changes in total scores on the Beck Depression Inventory (BDI) and the 12-item General Health Questionnaire from baseline to end of treatment. A physical examination, electrocardiography, complete blood count, blood chemistry, urinalysis, and pregnancy test (for women of childbearing potential) were performed at baseline and the end of treatment. Vital signs were measured during each visit. Adverse events (AEs) were recorded during the study and included those determined using the Systematic Assessment for Treatment Emergent Events-General Inquiry. Results: Forty-three Korean patients were screened for the study. Twenty-two patients (13 women, 9 men; mean [SD] age, 37.4 [12.4] years) were enrolled and 20 completed the study; 2 patients were lost to follow-up. The mean total score on the PHQ-15 from baseline to the end of treatment was significantly decreased (17.2 vs 4.3; P = 0.001), as was the mean total BDI score (12.8 vs. 6.3; P < 0.001). Overall, paroxetine was well-tolerated. Nausea and dry mouth were the most commonly reported treatment-emergent AEs (both, 5 [22.7%]); no serious AEs were reported. No abnormal laboratory results were observed. Conclusion: This open-label pilot study found that paroxetine had potential utility in the treatment of USD and was generally well-tolerated. These results suggest that adequately-powered, double-blind, placebo-controlled trials are warranted to more fully assess the efficacy and safety of paroxetine in the treatment of USD.

KW - paroxetine

KW - Patient Health Questionnaire

KW - pilot study

KW - undifferentiated somatoform disorder

UR - http://www.scopus.com/inward/record.url?scp=48049099922&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=48049099922&partnerID=8YFLogxK

U2 - 10.1016/j.curtheres.2008.06.004

DO - 10.1016/j.curtheres.2008.06.004

M3 - Article

VL - 69

SP - 221

EP - 231

JO - Current Therapeutic Research - Clinical and Experimental

JF - Current Therapeutic Research - Clinical and Experimental

SN - 0011-393X

IS - 3

ER -