临床试验/NCT02179268

NCT02179268已完成3 期

International Committee of Medical Journal Editors

Guiyang Medical University0 个研究点目标入组 203 人开始时间: 2012年3月最近更新: 2014年7月1日

适应症

干预措施

试验速览

阶段: 3 期
状态: 已完成
发起方
入组人数: 203
主要终点: bone mineral density (BMD)

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者记录与标识符相似试验

研究概览

简要总结

The aim of this five arm randomized trial was thus to compare selective serotonin reuptake inhibitor (SSRI)sertraline and citalopram to a dual reuptake inhibitor venlafaxine, a nor-adrenaline reuptake inhibitor reboxetine and a control group receiving placebo, with the primary endpoint being bone mineral density, and secondary endpoints being bone turnover markers.

详细描述

These results have overt clinical implications. They suggest a noxious effect, particularly of selective serotonin reuptake inhibitor (SSRI) antidepressants, on bone. Osteoporosis and fracture is overtly the problem of the elderly. However, the process of skeletal consolidation begins in childhood and the corresponding phase of demineralisation proceeds at a glacial pace and lasts throughout adulthood, as a consequence antidepressant therapy is likely to have a substantive impact on a phenomenon likely to manifest decades hence. It is known that numerically small changes in bone mineral density are associated with a substantial increase in fracture risk. Because the SSRIs have only been in widespread use for two decades, it is plausible that the consequences of this adverse effect are yet to emerge. These data consequently suggest a recalibration of the risk/benefit ratio of this class of agents and additionally beg the question of the potential role of screening for bone mineral density in this at-risk population group.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Single Group
主要目的: Supportive Care
盲法: None

入排标准

年龄范围: 20 Years 至 48 Years（Adult）
性别: All
接受健康志愿者: 否

入选标准

•Participants needed to have a primary diagnosis of depression with Zung Self Rated Depression Scale (SDS) > 53, and Hamilton Depression Scale (HAMD) ≥20.

排除标准

•The patients with hyperparathyroidism, myeloma or other disorders known to affect bone metabolism
•Use of estrogen
•Calcitonin drugs
•Previous antidepressant or other psychiatric drug use or prior treatment history

研究组 & 干预措施

sertraline & control

Active Comparator

sertraline 50-150mg tables for 1 year,Control (cognitive behavioral therapy by psychiatrists, 50min, every week for three months, every month, for nine months).

干预措施: sertraline (Drug)

sertraline & control

Active Comparator

sertraline 50-150mg tables for 1 year,Control (cognitive behavioral therapy by psychiatrists, 50min, every week for three months, every month, for nine months).

干预措施: citalopram (Drug)

sertraline & control

Active Comparator

sertraline 50-150mg tables for 1 year,Control (cognitive behavioral therapy by psychiatrists, 50min, every week for three months, every month, for nine months).

干预措施: venlafaxine (Drug)

sertraline & control

Active Comparator

sertraline 50-150mg tables for 1 year,Control (cognitive behavioral therapy by psychiatrists, 50min, every week for three months, every month, for nine months).

干预措施: reboxetine (Drug)

sertraline & control

Active Comparator

sertraline 50-150mg tables for 1 year,Control (cognitive behavioral therapy by psychiatrists, 50min, every week for three months, every month, for nine months).

干预措施: control (Behavioral)

citalopram & Control

Active Comparator

citalopram 20-40mg tables by mouth every day for 1 year, Control (cognitive behavioral therapy by psychiatrists, 50min, every week for three months, every month, for nine months).

干预措施: sertraline (Drug)

citalopram & Control

Active Comparator

citalopram 20-40mg tables by mouth every day for 1 year, Control (cognitive behavioral therapy by psychiatrists, 50min, every week for three months, every month, for nine months).

干预措施: citalopram (Drug)

citalopram & Control

Active Comparator

citalopram 20-40mg tables by mouth every day for 1 year, Control (cognitive behavioral therapy by psychiatrists, 50min, every week for three months, every month, for nine months).

干预措施: venlafaxine (Drug)

citalopram & Control

Active Comparator

citalopram 20-40mg tables by mouth every day for 1 year, Control (cognitive behavioral therapy by psychiatrists, 50min, every week for three months, every month, for nine months).

干预措施: reboxetine (Drug)

citalopram & Control

Active Comparator

citalopram 20-40mg tables by mouth every day for 1 year, Control (cognitive behavioral therapy by psychiatrists, 50min, every week for three months, every month, for nine months).

干预措施: control (Behavioral)

venlafaxine & control

Active Comparator

venlafaxine 75-100mg tables by mouth every day for 1 year, Control (cognitive behavioral therapy by psychiatrists, 50min, every week for three months, every month, for nine months).

干预措施: sertraline (Drug)

venlafaxine & control

Active Comparator

venlafaxine 75-100mg tables by mouth every day for 1 year, Control (cognitive behavioral therapy by psychiatrists, 50min, every week for three months, every month, for nine months).

干预措施: citalopram (Drug)

venlafaxine & control

Active Comparator

venlafaxine 75-100mg tables by mouth every day for 1 year, Control (cognitive behavioral therapy by psychiatrists, 50min, every week for three months, every month, for nine months).

干预措施: venlafaxine (Drug)

venlafaxine & control

Active Comparator

venlafaxine 75-100mg tables by mouth every day for 1 year, Control (cognitive behavioral therapy by psychiatrists, 50min, every week for three months, every month, for nine months).

干预措施: reboxetine (Drug)

venlafaxine & control

Active Comparator

venlafaxine 75-100mg tables by mouth every day for 1 year, Control (cognitive behavioral therapy by psychiatrists, 50min, every week for three months, every month, for nine months).

干预措施: control (Behavioral)