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临床试验/NCT00320632
NCT00320632已完成4 期

Psychopharmacology of Biogenic Amines in Depression

Harvard Medical School (HMS and HSDM)2 个研究点 分布在 1 个国家目标入组 43 人开始时间: 1990年8月1日最近更新:
适应症
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
43
试验地点
2
主要终点
Measured at Weeks 1, 4, and 6: Catecholamine metabolism and blood cell adenylate cyclase activity

研究概览

简要总结

This study will determine the effectiveness of desipramine in improving cellular signaling, and thereby decreasing symptoms of depression in people with major depressive disorder (MDD).

详细描述

MDD is a serious mental illness that can interfere with a person's ability to eat, sleep, work, and enjoy activities that were once pleasurable. It is characterized by several symptoms, including as the following: persistent sad, anxious, or "empty" mood; feelings of hopelessness or pessimism; and feelings of guilt, worthlessness, or helplessness. The receptor-G protein-adenylate cyclase enzyme complex (AC enzyme complex) is a major cell signaling system in the brain, blood, and other tissues in the body. Changes in this signaling system among blood cells have been observed in people with major depressive disorder. Research has shown that treatment with the benzodiazepine alprazolam corrects the signaling problem, and thereby improves symptoms of MDD. This study will determine whether impairments in the AC enzyme complex exist among depressed individuals. This study will also evaluate the effectiveness of desipramine, an antidepressant, in improving blood cell signaling, and thereby decreasing symptoms of depression in people with major depressive disorder.

Both healthy and depressed participants will be recruited for this study. All depressed participants in this study will first be assessed for depression severity using the Hamilton Depression Rating Scale. If eligible for the study, participants will be examined to determine AC enzyme complex functioning in both platelets and mononuclear leukocytes. A cohort of the depressed participants will be treated with desipramine. They will be examined to determine the drug's effect on AC enzyme complex functioning, as well as its effect on MDD symptoms, at Weeks 1, 4, and 6.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
19 Years 至 64 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Clinical diagnosis of MDD (as defined by SCID [DSM III-R] and a score of at least 15 on the 21-item Hamilton Depression Scale)
  • Able to swallow tablets, give urine and blood samples, and participate in periodic evaluations during the study
  • Healthy volunteers show no current Axis I or Axis II disorders and score less than 8 on the Hamilton Depression Scale

排除标准

  • Use of any of the following medications within the 2 weeks prior to study entry: psychoactive medication; aspirin; or nonsteroidal anti-inflammatory agents
  • Any alcohol or drug abuse within the 6 months prior to study entry
  • Any major medical disorder

结局指标

主要结局

Measured at Weeks 1, 4, and 6: Catecholamine metabolism and blood cell adenylate cyclase activity

Score on the 21-item Hamilton Depression Rating Scale

次要结局

未报告次要终点

研究者

发起方
Harvard Medical School (HMS and HSDM)
申办方类型
Other
责任方
Principal Investigator
主要研究者

JohnMooney

Principal Investigator

Harvard Medical School (HMS and HSDM)

研究点 (2)

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