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

Overview

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

Full Title of Study: “Effects of N-Acetyl-Cysteine on Oxidative Stress Biomarkers in Bipolar Patients With and Without Tobacco Use Disorder”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: September 2015

Detailed Description

The study subjects are bipolar depressive patients seeking outpatient treatment for bipolar affective disorder in the psychiatric outpatient clinic in Heath Unit System of the Network of Outpatient Hospital of the State University of Londrina , and tobacco use disorder according of criteria Diagnostic Statistical Manual for Mental Disorders, as control use never smokers. This is a placebo-controlled, 12 weeks, with a sample of 130 bipolar patients who sought treatment at the outpatient clinic of the Hospital of clinical psychiatry at State University of Londrina clinical trial , double-blind , randomized, from May 2015 to May 2016. Patients will be randomly allocated into two groups, double-blind, to receive a combination product (NAC, 1.8 g/day) or placebo for a period of 12 weeks. Both groups remain receiving maintenance treatment in outpatient psychiatry , and general medical and routinely reviews psychiatric . The dosage will be fixed 1.8 g /day of NAC administered in capsules taken 1 before breakfast, 1 before lunch and 1 before dinner is equal doses. The choice of this dosage is based on previous studies (Prado et al., submitted) , in which similar doses that are effective and well tolerated . To enable the process to be double-blind study medications (NAC or placebo ) will be dispensed monthly number and identical formulations and packages sealed by a pharmacist who will participate in the parallel test . Patients will do blood tests for assessment of oxidative stress at baseline will be randomized to use of NAC or placebo and at the final stage of the 12 weeks , when the new assessment and collection of blood for analysis of oxidative stress will be performed . Clinicians who conduct the study will be blinded to allocation of NAC or placebo for each patient . The NAC is a compound with a low rate of adverse effects , among them being described diarrhea, nausea and dermatological allergy. It is considered a very low risk medication. The placebo will be the basis of lactose, composed almost devoid of risk for side effects except if allergic to lactose (exclusion criterion ) .

Interventions

  • Dietary Supplement: N-Acetyl-Cysteine
    • drug: N-Acetyl-cysteine N-Acetyl-cysteine 1800 mg a day for 12 weeks versus placebo for 12 weeks

Arms, Groups and Cohorts

  • Placebo Comparator: placebo
    • 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.
  • Placebo Comparator: N-Acetyl-Cysteine
    • 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.

Clinical Trial Outcome Measures

Primary Measures

  • number cigarettes per day
    • Time Frame: baseline

Secondary Measures

  • Carbon Oxide exhalation
    • Time Frame: basal, 1, 2 and 3 months

Participating in This Clinical Trial

Inclusion Criteria

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. Exclusion Criteria:

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Universidade Estadual de Maringá
  • Provider of Information About this Clinical Study
    • Principal Investigator: Mauro Porcu, Professor of Psychiatry – Universidade Estadual de Maringá
  • Overall Official(s)
    • Sandra Nunes, M.D, Ph.D, Study Chair, Universidade Estadual de Londrina

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