ACOS - The effect of N-acetylcystein for depressive symptoms in patients with bipolar depression - A double blind randomized placebo-controlled trial with follow up - NACOS

Mental Health Service, Esbjerg0 个研究点开始时间: 2014年2月19日最近更新: 2017年1月9日

试验速览

暂无简介。

•Patients that meet the DSM-5 criteria of bipolar disorder type 1 or 2 (296-41-296.56 or 296.89) with at least one documented illness episode in the past six months, have had depressive symptoms at least 4 weeks before inclusion, MADRS = 18 at baseline, have been sick at least 4 weeks, between 18-64 years, fertile women with a negative pregnant test at baseline, turtle women using safe contraception in the study period, and patients who have given informed 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 80
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•Pregnant women, patients wishing pregnancy during the frame of the
•study, current suicidal thoughts, patients that have an intake of more than 500 mg NAC, 200 µm selenium, eller 500 IU of vitamin E every day is excluded. Patients who are hypersensitive to histamin, snf patients who have had ECT-treatment within the last 4 weeks, or have had medication change within the last 4 weeks. Patients with recent bleeding in respiratory, asthma, epilepsi or allergy towards NAC. People who cannot speak or understand the Danish language, or have not give or withdrawn informed consent. If patients change diagnosis during the study, and the primary diagnosis is not bipolar affective disorder is the participant excluded.

发起方

Mental Health Service, Esbjerg