Status:
UNKNOWN
Efficacy of N-Acetyl-Cysteine in Bipolar Disorder and Tobacco Use Disorder
Lead Sponsor:
Universidade Estadual de Maringá
Conditions:
Bipolar Disorder
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
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 bi...
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 Ho...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2015
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT02252341
Start Date
September 1 2014
End Date
September 1 2015
Last Update
April 17 2015
Active Locations (1)
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1
State University of Maringá
Maringá, Paraná, Brazil, 87083-240