The Effect of N- Acetylcysteine on Inflammatory & Oxidative Stress

Status Not yet recruiting

Clinical Trial Summary

Background: . Bipolar disorders and tobacco use disorder are top of the causes of disability and mortality worldwide Objective: The aim of this study was to evaluate N-acetyl-cysteine (NAC) as an adjunctive treatment in patients with bipolar .disorders and tobacco use disorder (TUD)

, to determine whether NAC reduces alterations in biomarkers of inflammatory and oxidative stress Methods: This study will be conducted as a double-blind, randomized, placebo controlles add NAC or placebo for .bipolar disorders and tobacco use disorder at Londrina State University, Brazil.

Clinical Trial Description

Tobacco use disorder and bipolar disorders are top of the causes of disability and mortality worldwide. The aim of this study was to evaluate N-acetyl-cysteine (NAC) as an adjunctive treatment in patients with Tobacco use disorder with comorbid bipolar disorder ( (N=72 NAC/placebo ) recruited from outpatients smoking cessation unit at Londrina State University, Brazil.

The design was a randomized, double-blind, placebo controlled clinical trial of 12 weeks of adjunctive treatment with N-acetyl-cysteine (NAC), 1800mg/day. Participants will be patients with bipolar disorders with and without TUD, they will allocated to one of two groups at random to receive NAC or placebo For the evaluation of oxidative stress biomarkers will be assess among others malondialdehyde (MDA), lipid hydroperoxide,nitric oxide metabolites (NOx), antioxidant potential total plasma (TRAP), advanced oxidation protein products (AOPP), superoxide dismutase (SOD), catalase, the total glutathione (GSH) and oxidized (GSSG), paraoxonase (PON 1) activity thiol group (SH-group).For the evaluation of inflammation biomarkers will be analyze : BDNF, GM-CSF, IFN-γ, IL-1β, IL-10, IL-12 (p70), IL-13, IL-15, IL-17, IL-1RA, IL-2, IL-2R, IL-4, IL-5, IL-6,IL-6R, IL-7, IL-8, Leptin, TNF-α, TNF-RI, TNF-RII, high-sensitivity C-reactive protein (hs-CRP), erythrocytes sedimentation rate (ESR), homocysteine, haptoglobin, albumin , uric acid and fibrinogen. ;

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

Clinical Trial Details

NCT number	NCT02420418
Study type	Interventional
Source	Universidade Estadual de Londrina
Contact	Décio Sabbatini Barbosa, PhD
Phone	+554399966381
Email	sabbatini2011@hotmail.com
Status	Not yet recruiting
Phase	N/A
Start date	July 2015
Completion date	May 2017

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT05111548` - Brain Stimulation and Cognitive Training - Efficacy	N/A
Completed	`NCT02855762` - Targeting the Microbiome to Improve Clinical Outcomes in Bipolar Disorder	N/A
Recruiting	`NCT05915013` - Alpha-Amino-3-Hydroxy-5-Methyl-4- Isoxazole Propionic Acid Receptor Components of the Anti-Depressant Ketamine Response	Phase 1
Recruiting	`NCT05206747` - Ottawa Sunglasses at Night for Mania Study	N/A
Completed	`NCT02513654` - Pharmacokinetics, Safety and Tolerability of Repeat Dosing Lamotrigine in Healthy Chinese Subjects	Phase 1
Recruiting	`NCT06313918` - Exercise Therapy in Mental Disorders-study	N/A
Completed	`NCT02304432` - Targeting a Genetic Mutation in Glycine Metabolism With D-cycloserine	Early Phase 1
Recruiting	`NCT06197048` - Effect of Nutritional Counseling on Anthropometry and Biomarkers in Patients Diagnosed With Schizophrenia/Psychosis or Bipolar Affective Disorder	N/A
Completed	`NCT03497663` - VIA Family - Family Based Early Intervention Versus Treatment as Usual	N/A
Completed	`NCT04284813` - Families With Substance Use and Psychosis: A Pilot Study	N/A
Completed	`NCT02212041` - Electronic Cigarettes in Smokers With Mental Illness	N/A
Recruiting	`NCT05030272` - Comparing Two Behavioral Approaches to Quitting Smoking in Mental Health Settings	N/A
Recruiting	`NCT04298450` - ED to EPI: Using SMS to Improve the Transition From the Emergency Department to Early Psychosis Intervention	N/A
Active, not recruiting	`NCT03641300` - Efficacy of Convulsive Therapies for Bipolar Depression	N/A
Not yet recruiting	`NCT04432116` - Time and Virtual Reality in Schizophrenia and Bipolar Disorder	N/A
Terminated	`NCT02893371` - Longitudinal Comparative Effectiveness of Bipolar Disorder Therapies
Completed	`NCT02970721` - Use of Psychotropic Medications Among Pregnant Women With Bipolar Disorder
Terminated	`NCT02909504` - Gao NARASD Lithium Study	Phase 4
Recruiting	`NCT03088657` - Design and Methods of the Mood Disorder Cohort Research Consortium (MDCRC) Study
Recruiting	`NCT02481245` - BezafibrateTreatment for Bipolar Depression: A Proof of Concept Study	Phase 2

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

The Effect of N- Acetylcysteine on Inflammatory and Oxidative Stress Biomarkers — nac

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms