NACOS - The Effect of N-acetylcystein for Depressive Symptoms in Patients Suffering From Bipolar Depression

• Status: Completed
• Trial end date: 2016-10-01
• Target enrollment: 0
• Participant gender: All

Summary

This trial investigate add-on treatment with 3 g NAC vs. placebo in 20 weeks in patients suffering from bipolar depression. The primary outcome is MADRS-score, and the secondary outcomes are other psychometric evaluations oxidative stress biomarkers in urine.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Region Syddanmark
• Treatments: Acetylcysteine; N-monoacetylcystine

Criteria

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.

Exclusion Criteria:

Pregnant women, patients wishing pregnancy during the frame of the study, current suicidality, patients that have an intake of more than 500 mg NAC, 200 μm selenium, or 500 IU of vitamin E every day is excluded. Patients who are hypersensitive to histamine, patients who have had ECT-treatment within the last 4 weeks. Patients with recent bleeding in respiratory, asthma, epilepsy 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 People who cannot speak or understand the Danish language, or have not give or withdrawn informed consent.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.