ISRCTN75768415已完成不适用
Pharmacological treatment of Depression: Phase II Lithium additio
Erasmus Medical Center (The Netherlands)0 个研究点目标入组 69 人开始时间: 2006年4月28日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 69
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •All non-responders in phase I.
- •In phase I inclusion criteria were:
- •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) greater than or equal to 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):
- •a. Kidney failure
- •b. Acute myocardial infarction
- •c. Myasthenia gravis
- •d. Breastfeeding
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