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

Bipolar Disorder Clinical Trial

— NACBD  

Official title:

Effects of N-Acetyl-Cysteine on Oxidative Stress Biomarkers in Bipolar Patients With and Without Tobacco Use Disorder

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02252341
• Other study ID #: MP-007
• Status: Enrolling by invitation
• Phase: Phase 4
• First received: July 4, 2014
• Last updated: April 16, 2015
• Start date: September 2014
• Est. completion date: September 2015

Study information

• Verified date: April 2015
• Source: Universidade Estadual de Maringá
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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

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 ) .

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 130
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bipolar Disorder
• Tobacco Use Disorder

Intervention

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

Locations

Country	Name	City	State
Brazil	State University of Maringá	Maringá	Paraná

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Estadual de Maringá

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Biological outcome measures	inflammatory and oxidative stress biomarkers	baseline and 3 months	No
Primary	number cigarettes per day		baseline	No
Secondary	Carbon Oxide exhalation		basal, 1, 2 and 3 months	No

External Links

•   departement of medicine - state university of Maringá