- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02252341
Efficacy of N-Acetyl-Cysteine in Bipolar Disorder and Tobacco Use Disorder (NACBD)
Effects of N-Acetyl-Cysteine on Oxidative Stress Biomarkers in Bipolar Patients With and Without Tobacco Use Disorder
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Locations
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Paraná
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Maringá, Paraná, Brazil, 87083-240
- State University of Maringá
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / 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. |
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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. |
drug: N-Acetyl-cysteine N-Acetyl-cysteine 1800 mg a day for 12 weeks versus placebo for 12 weeks
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
number cigarettes per day
Time Frame: baseline
|
baseline
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Carbon Oxide exhalation
Time Frame: basal, 1, 2 and 3 months
|
basal, 1, 2 and 3 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Biological outcome measures
Time Frame: baseline and 3 months
|
inflammatory and oxidative stress biomarkers
|
baseline and 3 months
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Sandra Nunes, M.D, Ph.D, Universidade Estadual de Londrina
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Chemically-Induced Disorders
- Pathologic Processes
- Substance-Related Disorders
- Bipolar and Related Disorders
- Disease
- Tobacco Use Disorder
- Bipolar Disorder
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Protective Agents
- Respiratory System Agents
- Antioxidants
- Antidotes
- Free Radical Scavengers
- Expectorants
- Acetylcysteine
- N-monoacetylcystine
Other Study ID Numbers
- MP-007
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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