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临床试验/ISRCTN73221288
ISRCTN73221288已完成未知

Pharmacological treatment of depression

Erasmus Medical Center (The Netherlands)0 个研究点目标入组 138 人开始时间: 2006年4月28日最近更新:
适应症

试验速览

阶段
未知
状态
已完成
发起方
入组人数
138

研究概览

研究设计

研究类型
Interventional

入排标准

性别
All

入选标准

  • For inclusion in the trial, patients must fulfill all of the following criteria:
  • 1. Age 18-65
  • 2. Major depressive disorder, single or recurrent episode (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition [DSM-IV])
  • 3. Hamilton Rating Scale for Depression (HRSD) (17 item) >/= 14
  • 4. Written informed consent

排除标准

  • Any of the following is regarded as a criterion for exclusion from the trial:
  • 1. Patients who are incapable of understanding the information and of giving informed consent. Also, patients who are unable to read or write
  • 2. Major depression with psychotic features (separate study)
  • 3. Bipolar I or II disorder
  • 4. Schizophrenia or other primary psychotic disorder
  • 5. Treatment of current episode with adequate trial of Imipramine or Venlafaxine
  • 6. Drug/alcohol dependence in the last 3 months
  • 7. Mental retardation (IQ <80)
  • 8. Women: pregnancy or possibility for pregnancy and no adequate contraceptive measures. Breastfeeding.
  • 9. Serious medical illness affecting central nervous system (CNS) e.g. M. Parkinson, systemic lupus erythematosus (SLE), brain tumor, cerebrovascular accident (CVA)
  • 10. Relevant medical illness as contra-indications for the use of study medication (Venlafaxine and Imipramine), such as recent myocardial infarction and severe liver or kidney failure
  • 11. Medication affecting CNS e.g. antidepressants and/or antipsychotics other than study medication, steroids (prednison), mood stabilisers, benzodiazepines (if not being tapered): >3 mg lorazepam (or equivalent)
  • 12. Direct electroconvulsive therapy (ECT) indication (e.g. very severely suicidal or refusal of food and drinking resulting in life threatening situation)
  • 13. Contra-indications for Lithium (Moleman, 1998):
  • 13.1. Kidney failure
  • 13.2. Acute myocardial infarction
  • 13.3. Myasthenia gravis
  • 13.4. Breastfeeding

研究者

发起方
Erasmus Medical Center (The Netherlands)

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