A randomised, double-blind, parallel-group comparison of the efficacy and the safety of venlafaxine versus nortriptyline in the treatment of depressed elderly inpatients

Altrecht GGZ (The Netherlands)0 个研究点目标入组 81 人开始时间: 2005年5月16日最近更新: 2015年1月13日

适应症

试验速览

暂无简介。

•1. Male or female inpatient
•2. Aged 60 years or older
•3. Meet the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria for:
•3.1. Major depression, single or recurrent episode (296.2x, 296.3x)
•3.2. Dysthymic disorder (300.4)
•3.3. Mood disorder due to a general medical condition, with depressive features or with major depressive-like episode (293.83)
•3.4. Substance induced mood disorder with depressive features (292.84)
•3.5. Depressive disorder not otherwise specified (i.e. minor depressive disorder) (311)
•4. Have a baseline Montgomery-Asberg Depression Rating Scale (MADRS) total score greater than or equal to 20
•5. Have a baseline Mini-Mental State Examination (MMSE) score greater than 15
•6. Written informed consent

•1. Known hypersensivity to venlafaxine or nortriptyline
•2. Previous unsuccessful treatment with venlafaxine for at least 4 weeks with a minimum dose of 75 mg/day or previous unsuccessful treatment with nortriptyline for at least 4 weeks with a serum level within the therapeutic range
•3. Relevant medical illness which is a contra-indication for the use of the study medication, such as myocardial infarction within previous 6 months
•4. Use of electroconvulsive therapy (ECT) within 30 days prior to baseline, use of a monoamine oxidase (MAO) inhibitor within 14 days, use of fluoxetine within 21 days, use of any antidepressant drug (except those allowed during the study as concomitant treatment) within 3 days prior to baseline
•5. Alcohol or drug abuse within the last year, according to DSM-IV criteria
•6. Presence of dementia, or a non-affective psychotic disorder, or a history of bipolar disorder (I and II), all according to DSM-IV criteria

发起方

Altrecht GGZ (The Netherlands)