Clinical Evaluation of Paroxetine (Paxil) in the Treatment of Obsessive Compulsive Disorder-A Randomized, Double-blind, Placebo-controlled Study-
|
Accession number;04A0774351
|
| Title;Clinical Evaluation of Paroxetine (Paxil) in the Treatment of Obsessive Compulsive Disorder-A Randomized, Double-blind, Placebo-controlled Study- |
| Author;
KAMIJIMA KUNITOSHI
(Showa Univ., School of Medicine, JPN)
MURASAKI MITSUKUNI
(Cnsyakuriken)
ASAI MASAHIRO
(Nihombashigakukandai Jimbunkeiei)
HIGUCHI TERUHIKO
(National Center Hospital for Mental, Nervous and Muscular Disorders, JPN)
NAKAJIMA TERUO
(Bukkyo Univ., JPN)
TAGA CHIAKI
(Kyotodainisekijujibyoin Seishinka)
MATSUNAGA HISATO
(Osaka City Univ., Med. Sch.)
|
Journal Title;Japanese Pharmacology & Therapeutics
|
Journal Code:Z0947A
|
ISSN:0386-3603
|
|
VOL.32;NO.9;PAGE.577-591(2004)
|
| Figure&Table&Reference;FIG.5, TBL.7, REF.25 |
| Pub. Country;Japan |
| Language;Japanese |
| Abstract;A double blind, placebo-controlled study of paroxetine hydrochloride hydrate was performed in 56 medical institutions on 191 Japanese patients with obsessive compulsive disorder (OCD) as defined in DSM-IV, criteria to demonstrate its efficacy and safety. Eligible patients received either paroxetine or placebo once daily after dinner for 12 weeks. From 6 weeks, based on physician assessment, paroxetine dosage could be further increased to 50 mg/day for the patients who were well tolerated but response insufficient. 1) The number of patients enrolled was 204, and the number of patients randomized was 191. Out of 191 patients, 94 patients for both paroxetine and placebo groups were assessed for efficacy as Full Analysis Set, and 189 for safety (95 in paroxetine group, and 94 in placebo group). 2) At 6 weeks and final evaluation, the total score on Y-BOCS in paroxetine group was significantly lower than that in placebo group (p=0.00002). Paroxetine showed superior OCD improvement. Paroxetine group was statistically superior over placebo group for final overall improvement rating also (p=0.0003). Furthermore, for patients who had not adequately responded to 40mg/day and were uptitrated to 50mg/day, the percentage of responders increased from 29.8% (14/47) at Week 6 to 53.2% (25/47) at endpoint. 3) In paroxetine group, the reported adverse events that significantly occurred more frequently than placebo group were nausea, insomnia, constipation and decreased appetite. Adverse events occurred most frequently within 7 days after administration and frequency did not increase after Day 7 administration, although higher dose was administrated. In summary, it was concluded that Paroxetine was effective and well tolerated in the treatment of OCD, and is expected to become a useful therapeutic agent. (author abst.) |
|
|
|
Related Articles;
|
|
