NACOS - The Effect of N-acetylcystein for Depressive Symptoms in Patients Suffering From Bipolar Depression
Condition: Bipolar Disorder
MeSH terms: Depression; Bipolar Disorder
Study type: Interventional
Phase: Phase 2

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.
    

Detailed 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.
    

Intervention name(s): N-acetylcysteine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Add-on treatment of NAC; Add-on treatment of placebo
Other intervention name(s): NAC
Intervention MeSH terms: Acetylcysteine; N-monoacetylcystine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Bipolar Disorder; Depression; Acetylcystein; Oxidative Stress; Urine