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

Bipolar Disorder Clinical Trial

Official title: NACOS - The Effect of N-acetylcystein for Depressive Symptoms in Patients Suffering From Bipolar Depression - A Double Blind Randomized Placebo-controlled Trial With Follow up

Status Completed

Clinical Trial 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.

Clinical Trial Description

Bipolar depression can be extremely invalidating because of the depressive symptoms that results in decreased social functioning which reduces the quality of life. Bipolar depression is associated with three times longer duration of disorder period compared to mania. This emphasizes the importance of optimal treatment opportunities for this particular group.

Psychological treatments are often based on effective maintenance therapy, with limited evidence of acute bipolar depression. The effect of lithium in the acute phase of depression is low, and the use of valproate is still unclear in bipolar depression. Lamotrigine and other antipsychotics, has some efficacy in bipolar depression but have considerable tolerance issue. The most effective treatment is quetiapine and quetiapine XR, but this treatment is associated with side effects such as sedation, weight gain and dyslipidemia.

Individuals suffering from bipolar depression has a recognisable dysregulated oxidative mechanisms. Evidence indicates that GSH, which is the central antioxidant in brain are vulnerable to degradation. However, N-acetylcystine (NAC) improves the L-cysteine supply and leads to increase GSH in the brain.

A clinical randomized controlled study with 75 patients, showed a significant decreases in the primary outcome measure (MADRS-score) compared to the control group. Furthermore, were the general health status and function improved in NAC group.

This double-blinded randomized placebo controlled trial is conducted, to demonstrate the efficacy of NAC on depressive symptoms in patients suffering from bipolar depression, and examine the effect of add-on treatment of NAC on the level of oxidative stress, quality of life and functioning.

In total 87 participants will be included and recruited from The Mental Health Service from Region of Southern Denmark, to ensure sufficient participants in the study.

The trial will run for a 24 weeks period for each participant. Participants in the study will be randomized to either NAC and standard treatment, or placebo and standard treatment for 20 weeks, followed by a 4-week follow-up period.

This trial is the first of its kind, analysing the level of oxidative stress in both blood and urine samples among people suffering from bipolar depression, to examine the add-on effect of NAC treatment.

The study receive academic and scientific advice from Ramus W. Licht, professor, ph.d, and clinical advice from Henrik E. Poulsen, professor, dr.med. This is two international professors in respectively bipolar disorder and oxidative stress. Furthermore, there is an international corporation and support from professor Michael Berk and dr. Olivia Dean from Deakin University, Australia, which have performed the previously trials concerning NAC treatment and bipolar depression.

The study medication has low side effects and low cost, both advantages, which are desirable for especially this vulnerable group of people. This trial may contribute to optimal treatment opportunities for people suffering from bipolar depression, and possibly other psychiatric patients as well. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bipolar Disorder
• Depression

• NCT number: NCT02294591
• Study type: Interventional
• Source: Region Syddanmark
• Status: Completed
• Phase: Phase 2
• Start date: November 2014
• Completion date: October 2016