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

NCT02294591 | Completed Phase 2 DMC

• 2 other identifiers: 356642012-004483-22
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Bipolar Disorder

Keywords

Bipolar Disorder; Depression; Acetylcystein; Oxidative Stress; Urine

Outcome Measures

Primary Outcomes (1)

• The total score of MADRS

  Change from baseline MADRS-score at 20 weeks

Secondary Outcomes (6)

• The total score of MES

  Change from baseline MES-score at 20 weeks

• The total score of WHO-5

  Change from baseline WHO-5-score at 20 weeks

• The total score of GAF-S

  Change from baseline GAF-S-score at 20 weeks

• The total score of GAF-F

  Change from baseline GAF-F-score at 20 weeks

• The total score of YMRS

  Change from baseline YMRS-score at 20 weeks

Study Arms (2)

NAC group

ACTIVE COMPARATOR

Receiving N-acetylcysteine as add-on treatment

Drug: N-acetylcysteine

Placebo group

PLACEBO COMPARATOR

Receiving placebo as add-on treatment

Drug: Placebo

Interventions

N-acetylcysteine DRUG

Add-on treatment of NAC

Also known as: NAC

NAC group

Placebo DRUG

Add-on treatment of placebo

Placebo group

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may not qualify if:

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 People who cannot speak or understand the Danish language, or have not give or withdrawn informed consent.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

Sponsors & Collaborators

• Region Syddanmark: lead

Study Sites (1)

Mental Health Services Esbjerg

Esbjerg, DK-6715, Denmark

Location

Related Publications (1)

• Ellegaard PK, Licht RW, Poulsen HE, Nielsen RE, Berk M, Dean OM, Mohebbi M, Nielsen CT. Add-on treatment with N-acetylcysteine for bipolar depression: a 24-week randomized double-blind parallel group placebo-controlled multicentre trial (NACOS-study protocol). Int J Bipolar Disord. 2018 Apr 5;6(1):11. doi: 10.1186/s40345-018-0117-9.

  PMID: 29619634 DERIVED

MeSH Terms

Conditions

Bipolar Disorder; Depression

Interventions

Acetylcysteine

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Cysteine; Amino Acids, Sulfur; Sulfur Compounds; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Connie T. Nielsen, Ph.D

  Mental Health Service, Esbjerg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant, MD, Ph.D

Study Record Dates

• First Submitted: November 6, 2014
• First Posted: November 19, 2014
• Study Start: November 1, 2014
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: November 28, 2016

Record last verified: 2016-11

Locations

DK (1)