A paroxetin klinikai hatékonysága és biztonságossága stroke-ot követo depresszióban: 4. Fázisú multicentrikus, nyílt, 26 hetes utánkövetéses klinikai vizsgálat eredményei

Sándor Horváth, Z. Karányi, Péter Harcos, Zoltán Nagy, György Németh, György Andor

Research output: Article

7 Citations (Scopus)

Abstract

Introduction: Prevalence of poststroke depression ranges from 20% to 50%. Treatment of depression positively correlate with the success of rehabilitation, quality of life, and pare down the poststroke patient's dependence. Aim: The primary goal of the study was to establish the therapeutic efficacy of paroxetin (measured by the changes of Hamilton Depression Scale Score) in poststroke depression. Secondary outcomes were changes in clinical status (based on Clinical Global Impression), alterations of mental capabilities (by Mini-Mental State Examination) and changes in quality of life (based on Quality of Life values). Method: An estimation of the efficacy of paroxetin treatment of 788 patients with post-stroke depression (Hamilton Depression Scale Score > 18) was performed in an open-label phase IV multicenter trial, during a clinical (8 weeks) as well as a follow-up period (a total of 26 weeks). The applied doses of paroxetin were: 20, 30 or 40 mg per day, subject to their therapeutic effect. Results: On the third week of the study (i.e.: at the 2nd visit) the mean Hamilton Depression Scale Score decreased significantly to 12.3 points; from a starting mean basic score of 24.8 points. At the conclusion of the clinical phase (by the end of the 8th week) we found an Hamilton Depression Scale Score of 8.6 points, which decreased further to 6.6 points by the end of the follow-up period (i.e.: the 26th week). At the end of the 3rd week 92% of the patients stated that paroxetin was effective while this number grew to 93.1% by the end the 8th week. Events related to secondary outcomes also showed significant improvements of similar size: by the end of the 8th week the clinical status of 92.8% of the patients improved (in 81.3% by a remarkable rate); mental output of the patients (based on Mini-Mental State Examination) grew significantly from a starting score of 26.7 to 27.9 and their Quality of Life values grew from 204 points to 238 points by the end of the 8th week and by the end of the 26th week it reached to 251 points; another indication of a significant improvement of their quality of life. In the course of the study 8.21% of the patients experienced side effects; the most frequent of these were: nausea/ vomiting, dizziness, headaches and diarrhea. Serious adverse events occurred in 1.9% of the patients during the 26 weeks period of the study although these were unrelated to the taking of paroxetin. In the course of the study the patients' compliance was clearly good: by the end of the 8th week 94%, at the end of the 26th week 90.7% of them reported for control visitation, in other words, during the 6 months study their dropout rate was less than 10%. Conclusion: the selective se roton in-reuptake inhibitor paroxetin effectively improved the symptoms of depression, the functional and cognitive performance, as well as the quality of life of patients with poststroke depression. The drug was safe and well tolerable.

Original languageHungarian
Pages (from-to)2397-2404
Number of pages8
JournalOrvosi Hetilap
Volume147
Issue number50
Publication statusPublished - dec. 17 2006

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Multicenter Studies
Clinical Trials
Safety
Quality of Life
Depression
Mentally Ill Persons
Dizziness
Therapeutic Uses
Patient Compliance
Nausea
Vomiting
Headache
Diarrhea
Rehabilitation
Stroke
Therapeutics
Pharmaceutical Preparations

Keywords

  • Clinical trial
  • Paroxetin
  • Poststroke depression
  • Therapy

ASJC Scopus subject areas

  • Medicine(all)

Cite this

A paroxetin klinikai hatékonysága és biztonságossága stroke-ot követo depresszióban : 4. Fázisú multicentrikus, nyílt, 26 hetes utánkövetéses klinikai vizsgálat eredményei. / Horváth, Sándor; Karányi, Z.; Harcos, Péter; Nagy, Zoltán; Németh, György; Andor, György.

In: Orvosi Hetilap, Vol. 147, No. 50, 17.12.2006, p. 2397-2404.

Research output: Article

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title = "A paroxetin klinikai hat{\'e}konys{\'a}ga {\'e}s biztons{\'a}goss{\'a}ga stroke-ot k{\"o}veto depresszi{\'o}ban: 4. F{\'a}zis{\'u} multicentrikus, ny{\'i}lt, 26 hetes ut{\'a}nk{\"o}vet{\'e}ses klinikai vizsg{\'a}lat eredm{\'e}nyei",
abstract = "Introduction: Prevalence of poststroke depression ranges from 20{\%} to 50{\%}. Treatment of depression positively correlate with the success of rehabilitation, quality of life, and pare down the poststroke patient's dependence. Aim: The primary goal of the study was to establish the therapeutic efficacy of paroxetin (measured by the changes of Hamilton Depression Scale Score) in poststroke depression. Secondary outcomes were changes in clinical status (based on Clinical Global Impression), alterations of mental capabilities (by Mini-Mental State Examination) and changes in quality of life (based on Quality of Life values). Method: An estimation of the efficacy of paroxetin treatment of 788 patients with post-stroke depression (Hamilton Depression Scale Score > 18) was performed in an open-label phase IV multicenter trial, during a clinical (8 weeks) as well as a follow-up period (a total of 26 weeks). The applied doses of paroxetin were: 20, 30 or 40 mg per day, subject to their therapeutic effect. Results: On the third week of the study (i.e.: at the 2nd visit) the mean Hamilton Depression Scale Score decreased significantly to 12.3 points; from a starting mean basic score of 24.8 points. At the conclusion of the clinical phase (by the end of the 8th week) we found an Hamilton Depression Scale Score of 8.6 points, which decreased further to 6.6 points by the end of the follow-up period (i.e.: the 26th week). At the end of the 3rd week 92{\%} of the patients stated that paroxetin was effective while this number grew to 93.1{\%} by the end the 8th week. Events related to secondary outcomes also showed significant improvements of similar size: by the end of the 8th week the clinical status of 92.8{\%} of the patients improved (in 81.3{\%} by a remarkable rate); mental output of the patients (based on Mini-Mental State Examination) grew significantly from a starting score of 26.7 to 27.9 and their Quality of Life values grew from 204 points to 238 points by the end of the 8th week and by the end of the 26th week it reached to 251 points; another indication of a significant improvement of their quality of life. In the course of the study 8.21{\%} of the patients experienced side effects; the most frequent of these were: nausea/ vomiting, dizziness, headaches and diarrhea. Serious adverse events occurred in 1.9{\%} of the patients during the 26 weeks period of the study although these were unrelated to the taking of paroxetin. In the course of the study the patients' compliance was clearly good: by the end of the 8th week 94{\%}, at the end of the 26th week 90.7{\%} of them reported for control visitation, in other words, during the 6 months study their dropout rate was less than 10{\%}. Conclusion: the selective se roton in-reuptake inhibitor paroxetin effectively improved the symptoms of depression, the functional and cognitive performance, as well as the quality of life of patients with poststroke depression. The drug was safe and well tolerable.",
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TY - JOUR

T1 - A paroxetin klinikai hatékonysága és biztonságossága stroke-ot követo depresszióban

T2 - 4. Fázisú multicentrikus, nyílt, 26 hetes utánkövetéses klinikai vizsgálat eredményei

AU - Horváth, Sándor

AU - Karányi, Z.

AU - Harcos, Péter

AU - Nagy, Zoltán

AU - Németh, György

AU - Andor, György

PY - 2006/12/17

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N2 - Introduction: Prevalence of poststroke depression ranges from 20% to 50%. Treatment of depression positively correlate with the success of rehabilitation, quality of life, and pare down the poststroke patient's dependence. Aim: The primary goal of the study was to establish the therapeutic efficacy of paroxetin (measured by the changes of Hamilton Depression Scale Score) in poststroke depression. Secondary outcomes were changes in clinical status (based on Clinical Global Impression), alterations of mental capabilities (by Mini-Mental State Examination) and changes in quality of life (based on Quality of Life values). Method: An estimation of the efficacy of paroxetin treatment of 788 patients with post-stroke depression (Hamilton Depression Scale Score > 18) was performed in an open-label phase IV multicenter trial, during a clinical (8 weeks) as well as a follow-up period (a total of 26 weeks). The applied doses of paroxetin were: 20, 30 or 40 mg per day, subject to their therapeutic effect. Results: On the third week of the study (i.e.: at the 2nd visit) the mean Hamilton Depression Scale Score decreased significantly to 12.3 points; from a starting mean basic score of 24.8 points. At the conclusion of the clinical phase (by the end of the 8th week) we found an Hamilton Depression Scale Score of 8.6 points, which decreased further to 6.6 points by the end of the follow-up period (i.e.: the 26th week). At the end of the 3rd week 92% of the patients stated that paroxetin was effective while this number grew to 93.1% by the end the 8th week. Events related to secondary outcomes also showed significant improvements of similar size: by the end of the 8th week the clinical status of 92.8% of the patients improved (in 81.3% by a remarkable rate); mental output of the patients (based on Mini-Mental State Examination) grew significantly from a starting score of 26.7 to 27.9 and their Quality of Life values grew from 204 points to 238 points by the end of the 8th week and by the end of the 26th week it reached to 251 points; another indication of a significant improvement of their quality of life. In the course of the study 8.21% of the patients experienced side effects; the most frequent of these were: nausea/ vomiting, dizziness, headaches and diarrhea. Serious adverse events occurred in 1.9% of the patients during the 26 weeks period of the study although these were unrelated to the taking of paroxetin. In the course of the study the patients' compliance was clearly good: by the end of the 8th week 94%, at the end of the 26th week 90.7% of them reported for control visitation, in other words, during the 6 months study their dropout rate was less than 10%. Conclusion: the selective se roton in-reuptake inhibitor paroxetin effectively improved the symptoms of depression, the functional and cognitive performance, as well as the quality of life of patients with poststroke depression. The drug was safe and well tolerable.

AB - Introduction: Prevalence of poststroke depression ranges from 20% to 50%. Treatment of depression positively correlate with the success of rehabilitation, quality of life, and pare down the poststroke patient's dependence. Aim: The primary goal of the study was to establish the therapeutic efficacy of paroxetin (measured by the changes of Hamilton Depression Scale Score) in poststroke depression. Secondary outcomes were changes in clinical status (based on Clinical Global Impression), alterations of mental capabilities (by Mini-Mental State Examination) and changes in quality of life (based on Quality of Life values). Method: An estimation of the efficacy of paroxetin treatment of 788 patients with post-stroke depression (Hamilton Depression Scale Score > 18) was performed in an open-label phase IV multicenter trial, during a clinical (8 weeks) as well as a follow-up period (a total of 26 weeks). The applied doses of paroxetin were: 20, 30 or 40 mg per day, subject to their therapeutic effect. Results: On the third week of the study (i.e.: at the 2nd visit) the mean Hamilton Depression Scale Score decreased significantly to 12.3 points; from a starting mean basic score of 24.8 points. At the conclusion of the clinical phase (by the end of the 8th week) we found an Hamilton Depression Scale Score of 8.6 points, which decreased further to 6.6 points by the end of the follow-up period (i.e.: the 26th week). At the end of the 3rd week 92% of the patients stated that paroxetin was effective while this number grew to 93.1% by the end the 8th week. Events related to secondary outcomes also showed significant improvements of similar size: by the end of the 8th week the clinical status of 92.8% of the patients improved (in 81.3% by a remarkable rate); mental output of the patients (based on Mini-Mental State Examination) grew significantly from a starting score of 26.7 to 27.9 and their Quality of Life values grew from 204 points to 238 points by the end of the 8th week and by the end of the 26th week it reached to 251 points; another indication of a significant improvement of their quality of life. In the course of the study 8.21% of the patients experienced side effects; the most frequent of these were: nausea/ vomiting, dizziness, headaches and diarrhea. Serious adverse events occurred in 1.9% of the patients during the 26 weeks period of the study although these were unrelated to the taking of paroxetin. In the course of the study the patients' compliance was clearly good: by the end of the 8th week 94%, at the end of the 26th week 90.7% of them reported for control visitation, in other words, during the 6 months study their dropout rate was less than 10%. Conclusion: the selective se roton in-reuptake inhibitor paroxetin effectively improved the symptoms of depression, the functional and cognitive performance, as well as the quality of life of patients with poststroke depression. The drug was safe and well tolerable.

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