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

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ClinicalTrials.gov Identifier: NCT02252341
Recruitment Status : Unknown
Verified April 2015 by Mauro Porcu, Universidade Estadual de Maringá.
Recruitment status was:  Enrolling by invitation
First Posted : September 30, 2014
Last Update Posted : April 17, 2015
Sponsor:
Information provided by (Responsible Party):
Mauro Porcu, Universidade Estadual de Maringá

Tracking Information
First Submitted Date  ICMJE July 4, 2014
First Posted Date  ICMJE September 30, 2014
Last Update Posted Date April 17, 2015
Study Start Date  ICMJE September 2014
Estimated Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 25, 2014)
number cigarettes per day [ Time Frame: baseline ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02252341 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 25, 2014)
Carbon Oxide exhalation [ Time Frame: basal, 1, 2 and 3 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: September 25, 2014)
Biological outcome measures [ Time Frame: baseline and 3 months ]
inflammatory and oxidative stress biomarkers
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Efficacy of N-Acetyl-Cysteine in Bipolar Disorder and Tobacco Use Disorder
Official Title  ICMJE Effects of N-Acetyl-Cysteine on Oxidative Stress Biomarkers in Bipolar Patients With and Without Tobacco Use Disorder
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
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 ) .

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Bipolar Disorder
Intervention  ICMJE Dietary Supplement: N-Acetyl-Cysteine
drug: N-Acetyl-cysteine N-Acetyl-cysteine 1800 mg a day for 12 weeks versus placebo for 12 weeks
Other Names:
  • N-acetyl-cysteine 1800 mg a day for 12 weeks or
  • N-Acetyl-cysteine 3 pills/day for 12 weeks.
Study Arms  ICMJE
  • 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.

    Intervention: Dietary Supplement: N-Acetyl-Cysteine
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: April 16, 2015)
130
Original Estimated Enrollment  ICMJE
 (submitted: September 25, 2014)
94
Estimated Study Completion Date  ICMJE September 2015
Estimated Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02252341
Other Study ID Numbers  ICMJE MP-007
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Mauro Porcu, Universidade Estadual de Maringá
Study Sponsor  ICMJE Universidade Estadual de Maringá
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Sandra Nunes, M.D, Ph.D Universidade Estadual de Londrina
PRS Account Universidade Estadual de Maringá
Verification Date April 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP