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

INTERVENTION: Trade Name: Mucolysin, mucomyst, Granon Product Name: NAC Product Code: R05CB01 Pharmaceutical Form: Capsule INN or Proposed INN: N‐acetylcystin CAS Number: 7218‐04‐4 Other descriptive name: S‐1,2‐DICHLOROVINYL‐N‐ACETYLCYSTEINE Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 500‐ Pharmaceutical form of the placebo: Capsule Route of administration of the placebo: Oral use CONDITION: Bipolar depression ; MedDRA version: 19.0 Level: LLT Classification code 10004936 Term: Bipolar depression System Organ Class: 100000004873 Therapeutic area: Psychiatry and Psychology [F] ‐ Mental Disorders [F03] PRIMARY OUTCOME: Main Objective: The aim of the study is to identify the effect of NAC on the depressive symptoms in patients with bipolar depression Primary end point(s): The total score of MADRS Secondary Objective: The secondary outcom is to measure the level of oxidative stress, quality of life and level of function. Timepoint(s) of evaluation of this end point: Baseline, 2, 10, 20 and 24 weeks SECONDARY OUTCOME: Secondary end point(s): Score of MES, SF‐12, GAF‐S, GAF‐F, CGI‐S, YMRS and measurement of oxidativ stress in biological material (urine) Timepoint(s) of evaluation of this end point: Baseline, 2, 10, 20 and 24 weeks INCLUSION CRITERIA: 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