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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

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

Condition or disease Intervention/treatment Phase
Bipolar Disorder Dietary Supplement: N-Acetyl-Cysteine Phase 4

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 ) .


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of N-Acetyl-Cysteine on Oxidative Stress Biomarkers in Bipolar Patients With and Without Tobacco Use Disorder
Study Start Date : September 2014
Estimated Primary Completion Date : September 2015
Estimated Study Completion Date : September 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bipolar Disorder

Arm Intervention/treatment
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.

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.




Primary Outcome Measures :
  1. number cigarettes per day [ Time Frame: baseline ]

Secondary Outcome Measures :
  1. Carbon Oxide exhalation [ Time Frame: basal, 1, 2 and 3 months ]

Other Outcome Measures:
  1. Biological outcome measures [ Time Frame: baseline and 3 months ]
    inflammatory and oxidative stress biomarkers



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02252341


Locations
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Brazil
State University of Maringá
Maringá, Paraná, Brazil, 87083-240
Sponsors and Collaborators
Universidade Estadual de Maringá
Investigators
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Study Chair: Sandra Nunes, M.D, Ph.D Universidade Estadual de Londrina

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Mauro Porcu, Professor of Psychiatry, Universidade Estadual de Maringá
ClinicalTrials.gov Identifier: NCT02252341     History of Changes
Other Study ID Numbers: MP-007
First Posted: September 30, 2014    Key Record Dates
Last Update Posted: April 17, 2015
Last Verified: April 2015

Keywords provided by Mauro Porcu, Universidade Estadual de Maringá:
smoking
inflammation
oxidative stress
NAC
treatment

Additional relevant MeSH terms:
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Disease
Bipolar Disorder
Tobacco Use Disorder
Pathologic Processes
Bipolar and Related Disorders
Mental Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Acetylcysteine
N-monoacetylcystine
Antiviral Agents
Anti-Infective Agents
Expectorants
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antidotes