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

November 24, 2016 updated by: Connie Thuree Nielsen, consultant, MD, ph.d, Region Syddanmark

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Esbjerg, Denmark, DK-6715
        • Mental Health Services Esbjerg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 64 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: NAC group
Receiving N-acetylcysteine as add-on treatment
Drug: N-acetylcysteine
Add-on treatment of NAC
Other Names:
  • NAC
Placebo Comparator: Placebo group
Receiving placebo as add-on treatment
Drug: Placebo
Add-on treatment of placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The total score of MADRS
Time Frame: Change from baseline MADRS-score at 20 weeks
Change from baseline MADRS-score at 20 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
The total score of MES
Time Frame: Change from baseline MES-score at 20 weeks
Change from baseline MES-score at 20 weeks
The total score of WHO-5
Time Frame: Change from baseline WHO-5-score at 20 weeks
Change from baseline WHO-5-score at 20 weeks
The total score of GAF-S
Time Frame: Change from baseline GAF-S-score at 20 weeks
Change from baseline GAF-S-score at 20 weeks
The total score of GAF-F
Time Frame: Change from baseline GAF-F-score at 20 weeks
Change from baseline GAF-F-score at 20 weeks
The total score of YMRS
Time Frame: Change from baseline YMRS-score at 20 weeks
Change from baseline YMRS-score at 20 weeks
The measurement of oxidative stress in biological material (urine)
Time Frame: Change from baseline oxidative stress measurement at 20 weeks
Change from baseline oxidative stress measurement at 20 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Region Syddanmark

Investigators

  • Principal Investigator: Connie T. Nielsen, Ph.D, Mental Health Service, Esbjerg

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2014

Primary Completion (Actual)

October 1, 2016

Study Completion (Actual)

October 1, 2016

Study Registration Dates

First Submitted

November 6, 2014

First Submitted That Met QC Criteria

November 14, 2014

First Posted (Estimate)

November 19, 2014

Study Record Updates

Last Update Posted (Estimate)

November 28, 2016

Last Update Submitted That Met QC Criteria

November 24, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 35664
  • 2012-004483-22 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Bipolar Disorder

Clinical Trials on N-acetylcysteine

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ireland

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe