Escitalopram in bipolar depression: a placebo-controlled study of acute and maintenance treatment. - Escitalopram in bipolar depression

ordfjord Psychiatric Centre0 个研究点目标入组 150 人开始时间: 2005年11月21日最近更新: 2012年3月19日

试验速览

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•? bipolar disorder type I or II in major depressive episode according to DSM-IV (as diagnosed by the Mini International Neuropsychiatric Interview (MINI))
•? MADRS score of at least 20 points
•? age 18 - 70
•? unchanged dose of mood stabilisers for at least six weeks prior to inclusion
•? voluntary, informed and written consent
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•? non-affective psychotic symptoms at screening or baseline
•? pregnancy or breast-feeding
•? fertile women without appropriate contraception
•? substance abuse or dependence during the last three months prior to baseline
•? mental retardation and organic brain disorders
•? suicide risk that mandates specific measures
•? novel (within three months) or unstable medical conditions
•? clinically significant abnormal results on medical examination or blood samples
•? exposure to escitalopram during the last three months
•? allergic reactions to citalopram or escitalopram
•? anorexia nervosa with body mass index below 18
•? formal psychotherapy started within six weeks of baseline
•? electroconvulsive therapy (ECT) during the current episode of depression
•? patients who are unlikely to be reliable and compliant with study procedures

发起方

ordfjord Psychiatric Centre