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临床试验/NCT00221494
NCT00221494撤回4 期

Can Additional Drug Therapy Accelerate Response Time to Antidepressants: A Double-blind, Placebo-controlled Randomization Research Study for Major Depression

Mark Frye2 个研究点 分布在 1 个国家开始时间: 2004年1月最近更新:
适应症
相关药物

试验速览

阶段
4 期
状态
撤回
发起方
试验地点
2

研究概览

简要总结

Antidepressants are commonly prescribed and are effective for treating depression. However, they generally take 4-6 weeks for a therapeutic response. This study is evaluating whether simultaneous treatment with thyroid hormone or pindolol can decrease the response time ("getting better faster") in patients who are starting SSRI treatment.

详细描述

Major depression is an illness with substantial personal and economic morbidity (Greenberg et al.1993) and antidepressants are the cornerstone of treatment. As antidepressants usually require 3-6 weeks of use before a response occurs, an effective antidepressant acceleration strategy would reduce the time of onset for an effective antidepressant response. This has significant clinical implications, as it could lead to reduced symptom morbidity, potentially reduce health care cost (i.e. shorter hospital length of stay), and improve functional capacity and quality of life.

The goal of this study is to enhance our understanding of strategies that accelerate or produce a more rapid treatment response in depression. This could lead to reduced symptom morbidity, potentially reduce health care cost (i.e. shorter hospital length of stay), and improve functional capacity and quality of life.

The study goals are: 1.) To assess whether the simultaneous commencement of liothyronine or pindolol to an SSRI can accelerate the treatment response (i.e. faster rate of improvement), 2.) To assess whether the simultaneous commencement of liothyronine or pindolol to an SSRI can augment or enhance treatment response (i.e. greater reduction in depressive symptoms at end of study phase), adn 3.) To assess whether gender influences the acceleration of augmentation response rate of liothyronine or pindolol.

研究设计

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

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients, male and female, between the ages of 18 to 65
  • DSM-IV criteria for major depressive disorder
  • No prior SSRI medication treatment (if a patient has discontinued a non-SSRI medication for side effects, they will not be excluded)
  • Ability to be followed clinically for 6 weeks
  • Each patient must understand the nature of the study and must sign an informed consent form

排除标准

  • Severe suicidality (as defined by Beck Depression Inventory Question 9, responses 2 or 3)
  • Major Axis I mental illness other than major depressive disorder
  • Unstable medical health specifically cardiovascular disease, abnormal EKG, history of severe drug allergy, poorly controlled diabetes, and asthma (pindolol contraindication)
  • History of thyroid disease or abnormal TFT's (stage I or II)
  • Need for adjunctive antipsychotic use or additional benzodiazepine during the study
  • Seizure disorder
  • A positive urine toxicology screen

研究者

发起方
Mark Frye
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Mark Frye

Principal Investigator

Mayo Clinic

研究点 (2)

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