Clinical Evaluation of Paxil Tablets in Patients with Depression or Depressive Episodes-A Study on Combination of Paxil Tablets and Benzodiazepines-
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Accession number;06A0784880
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| Title;Clinical Evaluation of Paxil Tablets in Patients with Depression or Depressive Episodes-A Study on Combination of Paxil Tablets and Benzodiazepines- |
| Author;
TSUBOI KOJI
(Toho Univ., Sch. of Med.)
TANAKA YOSHINOBU
(Glaxo Smith Kline K.K., JPN)
SATO KATSUAKI
(Glaxo Smith Kline K.K., JPN)
IJIRI SHOGO
(Glaxo Smith Kline K.K., JPN)
UECHI YASUYUKI
(Glaxo Smith Kline K.K., JPN)
NAGATA TSUTAE
(Glaxo Smith Kline K.K., JPN)
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Journal Title;Ther Res
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Journal Code:Y0681A
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ISSN:0289-8020
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VOL.27;NO.9;PAGE.1841-1863(2006)
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| Figure&Table&Reference;FIG.4, TBL.13, REF.15 |
| Pub. Country;Japan |
| Language;Japanese |
| Abstract;We conducted a multicenter clinical study of Paxil Tablets (paroxetine hydrochloride) in patients with depression or depressive episodes who have received benzodiazepine anxiolytics for at least 4 weeks at primary care clinics. The primary objective of the study was to evaluate changes in the symptoms of depression using the Hamilton Rating Scale for Depression (HAM-D). The primary efficacy analysis was performed on 169 patients. For the primary endpoint, absolute and percent changes from baseline in HAM-D total score were -57.04% and -12.1 points at Weeks 8. For secondary endpoints, HAM-D total score and Self-Rating Questionnaire for Depression (SRQ-D) score showed statistically significantly (p<0.0001) decreases from baseline at Weeks 8. The responder rate in Clinical Global Impression (global improvement) was 70.66% at Weeks 8. In addition, score of each sub-scale of MOS 8-Item Short-Form Health Survey (SF-8), an indicator for QOL assessment, showed a statistically significantly (p<0.0001) increase from baseline at Weeks 8. In conclusion, the results demonstrated the usefulness of Paxil in terms of improvement of depressive symptoms and QOL when additionally used in depressive patients who have received benzodiazepines for at least 4 weeks at primary care clinics. (author abst.) |
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