Journal of the Korean Academy of Child and Adolescent Psychiatry
- Volume 5 Issue 1
- /
- Pages.83-92
- /
- 1994
- /
- 2233-9183(eISSN)
A DOUBLE BLIND CROSS-OVER COMPARISON OF ANTIDEPRESSANT AND ANTIANXIETY EFFECTS OF PAROXETINE AND PLACEBO IN CHILD-ADOLESCENT AND ADULT DEPRESSIVE NEUROSIS
소아 ${\cdot}$ 청소년 및 성인 우울신경증 환자에 대한 Paroxetine의 항우울 및 항불안 효과 검증 : 위약과의 이중맹 교차 비교실험
- Kim, S. Peter (Department of Psychiatry, Samsung Medical Center) ;
-
Hong, Kyung-Sue
(Department of Psychiatry, Samsung Medical Center)
- Published : 1994.12.31
Abstract
Paroxetine is a potent and selective serotoin re-uptake inhibitor. It is well known as an effective and safe antidepressant and increasingly used for neurotic or non-psychotic depression with anxiety symptoms. The present study assessed antidepressant and antianxiety efficacy and tolerability of paroxetine against placebo in child-adolescent and adult depressive neurosis patients. 232 subjects aged 8-55 years and meeting DSM-III-R criteria for depressive neurosis or dysthymia were divided into 8 subgroups according to their sex and age(8-11 yeard old, 12-17 years old, 18-35 years old and 36-55 years old subgroup in each male and female group). In each subgroup, the randomly assigned half of the patients were treated with paroxetine(10-30mg/day) and the others with placebo for the first 2 weeks in double blind fashion. After 1 week of drug-washout period, paroxetine and placebo groups were crossed over. The depression and anxiety symptoms were assessed with Hamilton Depression Scale(HDS) and Hamilton Anxiety Scale(HAS) at baseline and every 1 week during the trial periods. The levels of reduction in HDS and HAS scores from baseline after 2-week trial were compared between paroxetine- and placebo- treated periods by paired t-test. In all the 8 subgroups, statistically significant differences between paroxetine and placebo were found on the antidepressant efficacy after 2-week treatment. The antidepressant efficacy of paroxetine compared to placebo was most prominent in child and adolescent female groups. On anxiety symptoms, paroxetine was also significantly more effective than placebo. The antianxiety efficacy of paroxetine compared to placebo was most prominent in male and female child groups and young adult female group aged 18-35 years. As for the adverse effects of paroxetine, 3 out of 232 subjects reported mild indigestion and abdominal pain. however, in all the 3 cases, the symptoms improved without reduction of dosage or discontinuation of the drug. In conclusion, paroxetine showed significantly higher antidepressant and antianxiety efficacy compared to placebo in child-adolescent and adult depressive neurosis patients after 2-week treatment. Further trials of paroxetine in depressive neurosis are warranted to elucidate the long-term antidepressant and antianxiety efficacy of paroxetine.
본 연구의 목적은, 선택적 serotonin 재흡수 차단제(selective serotonin re-uptake inhibitors : SSRI)로서 불안증상을 동반한 비정신병적 우울증에 효과적인 치료제로 알려지고 있는 paroxetine의 항우울 및 항불안 효과를 검증하고, 성별 및 연령별로 효과의 차이를 파악하는 것이다. 이를 위해 8~55세 사이의 우울신경증 환자 232명을 대상으로 paroxetine과 위약을 이중맹 교차방식으로 투여한 후, 우울 및 불안 증상의 호전도를 Hamilton Depression Scale(HDS)과 Hamilton Anxeity Scale(HAS)로 측정하여 다음과 같은 결과를 얻었다. 1) HDS로 측정된 우울증상에 대해, 성별 및 연령별로 구분된 8개 대상군에서 모두 paroxetine이 위약에 비해 통계적으로 유의하게 높은 호전 효과를 보였다. 2) HAS로 측정된 불안증상에 대해서도, 성별 및 연령별로 구분된 8개 대상군에서 모두 paroxetine이 위약에 비해 통계적으로 유의하게 높은 호전 효과를 보였다. 3) 위약과 비교시, paroxetine의 항우울 효과는 소아