N-Acetyl Cysteine Supplementation in Therapy Refractory Major Depressive Disorders

NCT02972398 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2022-09-22

No results posted yet for this study

Summary

The aim of this study is to evaluate the efficacy of N-acetylcysteine (NAC) add-on to antidepressant medication in treating patients who do not relieve during standard antidepressant treatment for 6 weeks at least. Meanwhile, secondary outcomes will include changes in some biomarkers and on specifically local brain activity (functional Magnetic Resonance Imaging, fMRI) and white matter integrity (Diffusion Tensor Imaging, DTI). The hypothesis of this study is that NAC has positive effects on refractory major depressive disorder patients with increased inflammatory activity.

Conditions

  • Major Depressive Disorders

Interventions

DRUG

N-acetylcysteine

Participants of interventional group receive 1000mg N-acetylcysteine twice daily for 12 weeks.

DRUG

placebo comparator of N-acetylcysteine

Participants of placebo group receive placebo comparator matching with N-acetylcysteine twice daily for 12 weeks.

Sponsors & Collaborators

  • Tianjin Anding Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-09-30
Primary Completion
2023-07-31
Completion
2023-09-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02972398 on ClinicalTrials.gov