跳至主要内容
临床试验/NCT00316160
NCT00316160已完成4 期

A Twelve-week, Multi-center, Randomized, Double-blind, Double-dummy, Parallel-group, Active Controlled, Escalating Dose Study to Compare the Effects on Sexual Functioning of Bupropion Hydrochloride Extended-release (WELLBUTRIN XL, 150-450 mg/Day) and Extended-release Venlafaxine (EFFEXOR XR, 75-225 mg/Day) in Subjects With Major Depressive Disorder

GlaxoSmithKline46 个研究点 分布在 1 个国家目标入组 347 人开始时间: 2004年9月最近更新:
适应症
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
347
试验地点
46
主要终点
To compare the effects of bupropion XL and venlafaxine XR on overall sexual functioning in outpatients with MDD as measured by mean changes in CSFQ-S total scores across Weeks 5, 6, 9 and 12.

研究概览

简要总结

Effects of two depression medication on sexual functioning

详细描述

A Twelve-week, Multi-center, Randomized, Double-blind, Double-dummy, Parallel-group, Active controlled, Escalating Dose Study to Compare the Effects on Sexual Functioning of Bupropion Hydrochloride Extended-release (WELLBUTRIN XL, 150-450 mg/day) and Extended-release Venlafaxine (EFFEXOR XR, 75-225 mg/day) in Subjects with Major Depressive Disorder

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • Past or current DSM-IV diagnosis of Bipolar Disorder I or II, schizophrenia or another psychotic disorder(s).
  • Primary DSM-IV diagnosis or received treatment for Panic Disorder, Obsessive Compulsive Disorder or Post Stress Disorder within previous 12 months.
  • Poses a homicidal or serious suicidal risk, have made an attempt within months prior to screening or who has ever been homicidal.
  • Myocardial infarction with 1 year of screening.
  • Taken ibupropion hydrochloride or venlafaxine in the last 6 months.
  • Positive urine test for illicit drug use or alcohol or substance abuse within the past 12 months.
  • Psychotherapy within 3 months.
  • Pregnant.
  • Electroconvulsive therapy or transcranial magnetic stimulation within 6 months prior of screening.
  • ECG or clinical evidence of atrial or ventricular hypertrophy.

结局指标

主要结局

To compare the effects of bupropion XL and venlafaxine XR on overall sexual functioning in outpatients with MDD as measured by mean changes in CSFQ-S total scores across Weeks 5, 6, 9 and 12.

次要结局

  • Efficacy, Safety, Tolerability, Health Outcome

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (46)

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