ISRCTN15858091已完成不适用
A randomised, controlled trial of interpersonal psychotherapy (IPT) and citalopram for depression in coronary artery disease
Montreal Heart Institute Research Center (Canada)0 个研究点目标入组 280 人开始时间: 2005年8月17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
- 280
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
- •Persons of either sex in age groups: 18 years and above.
- •1. Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) diagnosis of current major depressive episode based on the Structured Clinical Interview for Depression (SCID) with at least 4 weeks duration
- •2. Baseline score greater than 19 on the centralized, telephone-administered 24-item, Hamilton Depression Rating Scale (HAM-D)
- •3. Evidence of coronary artery disease (CAD) based on hospital chart evidence of a previous hospitalization for acute myocardial infarction, or coronary angiographic evidence of greater than 50% blockage in at least one major coronary artery, or prior revascularization
- •4. Stable CAD based on physician?s clinical judgement
- •5. Provision of informed consent
排除标准
- •1. Less than 18 years of age
- •2. Coronary bypass surgery planned during the next 4 months
- •3. Canadian Cardiovascular Society Angina Class (CCS) = 4
- •4. SCID documented bipolar disorder, major depression with psychotic features or evidence of substance abuse or dependency during the previous 12 months
- •5. Serious suicide or risk based on clinical judgment
- •6. Use of anti-depressants, lithium or anti-convulsants for mood disorder
- •7. Currently undergoing any form of psychotherapy
- •8. Absence of response to a previous adequate trial of citalopram or IPT
- •9. Two previous unsuccessful trials of treatment for depression for the index episode
- •10. Lifetime history of early termination (less than 8 weeks) of citalopram because of adverse events or side-effects
- •11. Lifetime history of early termination (less than 8 weeks) of two other selective serotonin reuptake inhibitor (SSRI) antidepressants (paroxetine, fluoxetine, fluvoxamine, sertraline) because of adverse events or side-effects
- •12. Significant cognitive problems (Mini-Mental Status Exam [MMSE] less than 24)
- •13. Depression due to a general medical condition based on clinical judgment
- •14. Participation in other trials
- •15. Inability to speak French or English
- •16. Investigator?s judgment that a patient is unable or unwilling to comply with the study regimen
研究者
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