ACOS - Effect of novel treatment for depressive symptoms in patients with bipolar depression - A double blind randomized placebo-controlled trial with follow up

Phase 1

Conditions: Bipolar depression
MedDRA version: 19.0Level: LLTClassification code 10004936Term: Bipolar depressionSystem Organ Class: 100000004873
Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

Registration Number: EUCTR2012-004483-22-DK

Lead Sponsor: Mental Health Service, Esbjerg

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

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

Exclusion Criteria

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 People who cannot speak or understand the Danish language, or have not give or withdrawn informed consent.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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The aim of the study is to identify the effect of NAC on the depressive symptoms in patients with bipolar depression;Secondary Objective: The secondary outcom is to measure the level of oxidative stress, quality of life and level of function.;Primary end point(s): The total score of MADRS;Timepoint(s) of evaluation of this end point: Baseline, 2, 10, 20 and 24 weeks

Secondary Outcome Measures

Name	Time	Method
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