A double blind, randomized singlecentre study with a washout period, comparing 2 treatment strategies.

none0 个研究点目标入组 69 人开始时间: 待定最近更新: 2024年2月28日

适应症

试验速览

•1. Patients whom are incapable to understand the information and to give informed consent. And patients whom 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 last 3 months;
•7. Mental retardation (IQ smaller than 80);
•8. Women: pregnancy or possibility for pregnancy and no adequate contraceptive measures. Breastfeeding;
•9. Serious medical illness affecting CNS, e.g.: M. Parkinson, SLE, brain tumor, 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: see appendix ‘Moleman P. 1998. Praktische psychofarmacologie. Derde druk. Bohn Stafleu Van Loghum. Page 19’);
•12. Direct 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 myocard infarct;
•c. Myasthenia gravis;
•d. Breastfeeding.

发起方

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