[Effects of paroxetine with or without zolpidem on depression with insomnia: a multi-center randomized comparative study].
OBJECTIVE
To compare the effects of paroxetine with or without zolpidem on depression with insomnia.


METHODS
229 consecutive outpatients with the diagnosis of major depression based on the CCMD-3 criteria who visited the departments of mental counseling, psychiatric, or neurology in 11 general hospitals the country over during a period of 4 weeks, were randomly allocated into 2 groups: paroxetine + zolpidem group (Group A, treated with paroxetine 10 - 20 mg/d and zolpidem 10 mg/d H. d. for 4 weeks) and paroxetine group (Group B, treated with paroxetine only), among which 221 underwent intention-to-treat analysis and 207 underwent completer analysis (CA). Hamilton Anxiety Scale (HAMA), Hamilton Depression Scale-17 (HAMD-17), Pittsburg sleep quality index (PSQI), and 36-item Short Form Health Survey (SF-36) were used to evaluate the outcomes.


RESULTS
One week after the beginning of treatment the reduction of PSQI score of Group A was 5.7, showing an improvement of sleep quality, significantly higher than that of Group B (1.6), and 4 weeks later the reduction of PSQI of Group A was 9.7 +/- 3.6, significantly higher than that of Group B (6.0 +/- 3.5, both P = 0.000). Four weeks after the beginning of treatment, the HAMD reduction rate of Group A was 68.5%, significantly higher than that of Group B (56.8%, P < 0.01), and the HAMA reduction rate of Group A was 66.2%, significantly higher than that of Group B (57.1%, P < 0.01), and the SF-36 score of Group A was 66 +/- 19 (last observation carry forward analysis) or 67 +/- 19 (CA), significantly higher than those of Group B (38 +/- 16 or 67 +/- 19 respectively, both P = 0.000).


CONCLUSIONS
selective serotonin reuptake inhibitor antidepressant combined with hypnotic augments the effects of antidepressant on the depressive and anxiety symptoms.
Ji
Jian-Lin
JL
Department of Psychological Medicine, Zhongshan Hospital, Fudan University, Shanghai 200032, China.
Liu
Wen-Juan
WJ
Zhang
Ning
N
Chen
Zhi-Qing
ZQ
Zheng
An-Lin
AL
Mei
Qi-Yi
QY
Pan
Ji-Yang
JY
Zhao
Zhong-Xin
ZX
Tao
Ming
M
Wang
Yu-Ping
YP
Wei
Jing
J
D018687:Antidepressive Agents, Second-Generation / Q000627:therapeutic use; D003863:Depression / Q000150:complications / Q000188:drug therapy*; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D006993:Hypnotics and Sedatives / Q000627:therapeutic use; D008297:Male; D017063:Outcome Assessment, Health Care; D017374:Paroxetine / Q000627:therapeutic use*; D011725:Pyridines / Q000627:therapeutic use*; D007319:Sleep Initiation and Maintenance Disorders / Q000150:complications / Q000188:drug therapy*; D011795:Surveys and Questionnaires; D000077334:Zolpidem