Pharmacological treatment of psychotic depressio

niversity Medical Center Utrecht (UMCU) (The Netherlands)0 个研究点目标入组 160 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. Aged 18 - 65 years
•2. Major depressive disorder, single or recurrent episode, with psychotic features (Diagnostic and Statistical Manual of Mental Disorders, fourth edition [DSM-IV])
•3. Hamilton Rating Scale for Depression (HRSD) (17 item)
•4. Written informed consent

•Any of the following is regarded as a criterion for exclusion from the trial:
•1. Bipolar I or II disorder
•2. Schizophrenia or other primary psychotic disorder
•3. Treatment of current episode with adequate trial of imipramine or venlafaxine:
•3.1. Imipramine at least four weeks with adequate blood levels
•3.2. Venlafaxine at least four weeks 300 mg dd
•4. Drug/alcohol dependence in the last three months
•5. Mental retardation (intelligent quotient [IQ] less than 80)
•6.1. Pregnancy or possibility for pregnancy and no adequate contraceptive measures
•6.2. Breast-feeding
•7. Serious medical illness affecting central nervous system (CNS) e.g. Parkinson's Disease, systemic lupus erythematosus (SLE), brain tumour, cerebrovascular accident (CVA)
•8. Relevant medical illness as contra-indications for the use of study medication, such as recent myocardial infarction
•9. Medication affecting CNS, e.g. anti-depressives and/or anti-psychotics other than study medication, steroids (prednisone), mood stabilisers, benzodiazepines (if not being tapered): greater than 3 mg lorazepam (or equivalent)
•10. Direct electroconvulsive therapy (ECT) indication (e.g. very severe suicidality or refusal of food and drinking resulting in a life threatening situation)
•11. Monoamine oxidase inhibitor (MAO-I) less than one week before start of medication free period

发起方

niversity Medical Center Utrecht (UMCU) (The Netherlands)