The predictors of response to antidepressant treatment in patients with resistant depression-an integrative approach - open-label, prospective study

Ministry of Health (Czech Republic) - Internal Grant Agency0 个研究点目标入组 40 人开始时间: 2013年6月27日最近更新: 2019年2月11日

试验速览

•1. Patients suffering from Major depressive disorder (recurrent or single episode) diagnosed according to Diagnostic and Statistical Manual of the American Psychiatric Association-IV. revision (DSM-IV) criteria, confirmed using The Mini-International Neuropsychiatric Interview - M.I.N.I., Czech version 5.0.0.
•2. Patients fulfilling at least Stage I (=1 previous, unsuccessful, adequate, antidepressant treatment) criteria for resistant depression according to Thase and Rush.
•3. The mental ability to understand and sign Informed Consent Form.
•4. The score in the Montgomery and Åsberg Rating Scale (MADRS) =25 and the score in Clinical Global Impression (CGI)=4.
•5. Inpatients.
•6. Age between 18 and 65 years, either sex

•1. Contraindications of treatment with selective serotonin reuptake inhibitors (SSRIs) (citalopram, escitalopram, fluoxetine, fluvoxamine, sertraline, paroxetine) according to Summary of Product (SPC)
•2. Psychiatric comorbidity on axis I and II according to DSM IV in the 6 months before enrollment to the study
•3. Patients with severe somatic disorders (cardiovascular disease, neoplasms, endocrinology disorders etc.) that could be associated with depression due to somatic disease.
•4. Patients treated with electroconvulsive therapy less than 3 month before enrollment or suffering from neurologic disorder (e.g., epilepsy, head trauma with loss of consciousness) and patients using any treatment which can strongly affect EEG.
•5. Patients who were treated unsuccessfully with more than one SSRIs during index episode.

发起方

Ministry of Health (Czech Republic) - Internal Grant Agency