Efficacy of N-Acetyl-Cysteine in Bipolar Disorder and Tobacco Use Disorder

NCT02252341 | Unknown Phase 4 DMC

• 1 other identifier: MP-007
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

Effects of N-Acetyl-Cysteine in patients with bipolar depression (primary outcome is Hamilton Depression Rating Scale) with and without tobacco use disorder and on inflammatory and oxidative stress biomarkers

Conditions

Bipolar Disorder

Keywords

smoking; inflammation; oxidative stress; NAC; treatment

Outcome Measures

Primary Outcomes (1)

• number cigarettes per day

  baseline

Secondary Outcomes (1)

• Carbon Oxide exhalation

  basal, 1, 2 and 3 months

Other Outcomes (1)

• Biological outcome measures

  baseline and 3 months

Study Arms (2)

placebo

PLACEBO COMPARATOR

Dietary Supplement: N-Acetyl-Cysteine Phase 4 Study Type: Interventional Study Design: Treatment, Parallel Assignment, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Randomized, Efficacy Study Primary Outcome Measure: Hamilton Depression Rating Scale \[Time Frame: baseline, 1, 2, 3 months\] \[Designated as safety issue: Yes\] Secondary Outcome Measures: Carbon Oxide exhalation \[Time Frame: basal, 1, 2, 3 months\] \[Designated as safety issue: Yes\] Other Pre-specified Outcome Measures: Biological outcome measures \[Time Frame: baseline and 3 months\] \[Designated as safety issue: Yes\] inflammatory and oxidative stress biomarkers N-Acetyl-cysteine 1800 mg / day will be taken for 12 weeks versus placebo 12 weeks.

N-Acetyl-Cysteine

PLACEBO COMPARATOR

Study Type: Interventional Study Design: Treatment, Parallel Assignment, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Randomized, Efficacy Study Official Title: Effects of N-Acetyl-Cysteine on Oxidative Stress Biomarkers in Bipolar Patients With and Without Tobacco Use Disorder Primary Outcome Measure: Hamilton Depression Rating Scale \[Time Frame: baseline\] \[Designated as safety issue: Yes\] Secondary Outcome Measures: Carbon Oxide exhalation \[Time Frame: basal, 1, 2, 3 months\] \[Designated as safety issue: Yes\] Other Pre-specified Outcome Measures: Biological outcome measures \[Time Frame: baseline and 3 months\] \[Designated as safety issue: Yes\] inflammatory and oxidative stress biomarkers Placebo will be taken for 12 weeks.

Dietary Supplement: N-Acetyl-Cysteine

Interventions

N-Acetyl-Cysteine DIETARY_SUPPLEMENT

drug: N-Acetyl-cysteine N-Acetyl-cysteine 1800 mg a day for 12 weeks versus placebo for 12 weeks

Also known as: N-acetyl-cysteine 1800 mg a day for 12 weeks or, N-Acetyl-cysteine 3 pills/day for 12 weeks.

N-Acetyl-Cysteine

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• To be included in this study participants between 18 and 65 years, both sexes , all races, capacity to consent to the study and carefully follow the guidelines and procedures and sign the term of free and informed consent. Patients with bipolar depression will be included with score above 21 on the Hamilton Depression Rating Scale (17 items) and above 14 on the Beck Depression Inventory.

You may not qualify if:

• We will exclude: patients with delirium or cognitive deficits or failure of understanding and reflection to change. Furthermore, dementia , amnesia and other cognitive disorders, infectious diseases such as hepatitis B and C , HIV, chronic diseases such as renal failure, obstructive pulmonary disease and autoimmune interferon treatment, stroke , Parkinson's disease, pathological use of psychoactive substances and consumption of antioxidants. These situations can affect an inflammatory and / or immune process

Sponsors & Collaborators

• Universidade Estadual de Maringá: lead

Study Sites (1)

State University of Maringá

Maringá, Paraná, 87083-240, Brazil

Location

Related Publications (1)

• Porcu M, Urbano MR, Verri WA Jr, Barbosa DS, Baracat M, Vargas HO, Machado RCBR, Pescim RR, Nunes SOV. Effects of adjunctive N-acetylcysteine on depressive symptoms: Modulation by baseline high-sensitivity C-reactive protein. Psychiatry Res. 2018 May;263:268-274. doi: 10.1016/j.psychres.2018.02.056. Epub 2018 Mar 13.

  PMID: 29605103 DERIVED

Related Links

• departement of medicine - state university of Maringá

MeSH Terms

Conditions

Bipolar Disorder; Smoking; Inflammation

Interventions

Acetylcysteine

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders; Behavior; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Study Officials

• Sandra Nunes, M.D, Ph.D

  Universidade Estadual de Londrina

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• 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: Professor of Psychiatry

Study Record Dates

• First Submitted: July 4, 2014
• First Posted: September 30, 2014
• Study Start: September 1, 2014
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: April 17, 2015

Record last verified: 2015-04

Locations

BR (1)