<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02252341</url>
  </required_header>
  <id_info>
    <org_study_id>MP-007</org_study_id>
    <nct_id>NCT02252341</nct_id>
  </id_info>
  <brief_title>Efficacy of N-Acetyl-Cysteine in Bipolar Disorder and Tobacco Use Disorder</brief_title>
  <acronym>NACBD</acronym>
  <official_title>Effects of N-Acetyl-Cysteine on Oxidative Stress Biomarkers in Bipolar Patients With and Without Tobacco Use Disorder</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidade Estadual de Maringá</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universidade Estadual de Maringá</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Effects of N-Acetyl-Cysteine in patients with bipolar depression (primary outcome is Hamilton&#xD;
      Depression Rating Scale) with and without tobacco use disorder and on inflammatory and&#xD;
      oxidative stress biomarkers&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study subjects are bipolar depressive patients seeking outpatient treatment for bipolar&#xD;
      affective disorder in the psychiatric outpatient clinic in Heath Unit System of the Network&#xD;
      of Outpatient Hospital of the State University of Londrina , and tobacco use disorder&#xD;
      according of criteria Diagnostic Statistical Manual for Mental Disorders, as control use&#xD;
      never smokers.&#xD;
&#xD;
      This is a placebo-controlled, 12 weeks, with a sample of 130 bipolar patients who sought&#xD;
      treatment at the outpatient clinic of the Hospital of clinical psychiatry at State University&#xD;
      of Londrina clinical trial , double-blind , randomized, from May 2015 to May 2016. Patients&#xD;
      will be randomly allocated into two groups, double-blind, to receive a combination product&#xD;
      (NAC, 1.8 g/day) or placebo for a period of 12 weeks. Both groups remain receiving&#xD;
      maintenance treatment in outpatient psychiatry , and general medical and routinely reviews&#xD;
      psychiatric . The dosage will be fixed 1.8 g /day of NAC administered in capsules taken 1&#xD;
      before breakfast, 1 before lunch and 1 before dinner is equal doses.&#xD;
&#xD;
      The choice of this dosage is based on previous studies (Prado et al., submitted) , in which&#xD;
      similar doses that are effective and well tolerated . To enable the process to be&#xD;
      double-blind study medications (NAC or placebo ) will be dispensed monthly number and&#xD;
      identical formulations and packages sealed by a pharmacist who will participate in the&#xD;
      parallel test . Patients will do blood tests for assessment of oxidative stress at baseline&#xD;
      will be randomized to use of NAC or placebo and at the final stage of the 12 weeks , when the&#xD;
      new assessment and collection of blood for analysis of oxidative stress will be performed .&#xD;
      Clinicians who conduct the study will be blinded to allocation of NAC or placebo for each&#xD;
      patient .&#xD;
&#xD;
      The NAC is a compound with a low rate of adverse effects , among them being described&#xD;
      diarrhea, nausea and dermatological allergy. It is considered a very low risk medication. The&#xD;
      placebo will be the basis of lactose, composed almost devoid of risk for side effects except&#xD;
      if allergic to lactose (exclusion criterion ) .&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date>September 2014</start_date>
  <completion_date type="Anticipated">September 2015</completion_date>
  <primary_completion_date type="Anticipated">September 2015</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>number cigarettes per day</measure>
    <time_frame>baseline</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Carbon Oxide exhalation</measure>
    <time_frame>basal, 1, 2 and 3 months</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Biological outcome measures</measure>
    <time_frame>baseline and 3 months</time_frame>
    <description>inflammatory and oxidative stress biomarkers</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">130</enrollment>
  <condition>Bipolar Disorder</condition>
  <arm_group>
    <arm_group_label>placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>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&#xD;
Primary Outcome Measure:&#xD;
Hamilton Depression Rating Scale [Time Frame: baseline, 1, 2, 3 months] [Designated as safety issue: Yes]&#xD;
Secondary Outcome Measures:&#xD;
Carbon Oxide exhalation [Time Frame: basal, 1, 2, 3 months] [Designated as safety issue: Yes]&#xD;
Other Pre-specified Outcome Measures:&#xD;
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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>N-Acetyl-Cysteine</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Study Type: Interventional Study Design: Treatment, Parallel Assignment, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Randomized, Efficacy Study&#xD;
Official Title: Effects of N-Acetyl-Cysteine on Oxidative Stress Biomarkers in Bipolar Patients With and Without Tobacco Use Disorder&#xD;
Primary Outcome Measure:&#xD;
Hamilton Depression Rating Scale [Time Frame: baseline] [Designated as safety issue: Yes]&#xD;
Secondary Outcome Measures:&#xD;
Carbon Oxide exhalation [Time Frame: basal, 1, 2, 3 months] [Designated as safety issue: Yes]&#xD;
Other Pre-specified Outcome Measures:&#xD;
Biological outcome measures [Time Frame: baseline and 3 months] [Designated as safety issue: Yes] inflammatory and oxidative stress biomarkers&#xD;
Placebo will be taken for 12 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>N-Acetyl-Cysteine</intervention_name>
    <description>drug: N-Acetyl-cysteine N-Acetyl-cysteine 1800 mg a day for 12 weeks versus placebo for 12 weeks</description>
    <arm_group_label>N-Acetyl-Cysteine</arm_group_label>
    <other_name>N-acetyl-cysteine 1800 mg a day for 12 weeks or</other_name>
    <other_name>N-Acetyl-cysteine 3 pills/day for 12 weeks.</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        To be included in this study participants between 18 and 65 years, both sexes , all races,&#xD;
        capacity to consent to the study and carefully follow the guidelines and procedures and&#xD;
        sign the term of free and informed consent. Patients with bipolar depression will be&#xD;
        included with score above 21 on the Hamilton Depression Rating Scale (17 items) and above&#xD;
        14 on the Beck Depression Inventory.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        We will exclude: patients with delirium or cognitive deficits or failure of understanding&#xD;
        and reflection to change. Furthermore, dementia , amnesia and other cognitive disorders,&#xD;
        infectious diseases such as hepatitis B and C , HIV, chronic diseases such as renal&#xD;
        failure, obstructive pulmonary disease and autoimmune interferon treatment, stroke ,&#xD;
        Parkinson's disease, pathological use of psychoactive substances and consumption of&#xD;
        antioxidants. These situations can affect an inflammatory and / or immune process&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sandra Nunes, M.D, Ph.D</last_name>
    <role>Study Chair</role>
    <affiliation>Universidade Estadual de Londrina</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>State University of Maringá</name>
      <address>
        <city>Maringá</city>
        <state>Paraná</state>
        <zip>87083-240</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <link>
    <url>http://www.dmd.uem.br</url>
    <description>departement of medicine - state university of Maringá</description>
  </link>
  <verification_date>April 2015</verification_date>
  <study_first_submitted>July 4, 2014</study_first_submitted>
  <study_first_submitted_qc>September 25, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 30, 2014</study_first_posted>
  <last_update_submitted>April 16, 2015</last_update_submitted>
  <last_update_submitted_qc>April 16, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 17, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universidade Estadual de Maringá</investigator_affiliation>
    <investigator_full_name>Mauro Porcu</investigator_full_name>
    <investigator_title>Professor of Psychiatry</investigator_title>
  </responsible_party>
  <keyword>smoking</keyword>
  <keyword>inflammation</keyword>
  <keyword>oxidative stress</keyword>
  <keyword>NAC</keyword>
  <keyword>treatment</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tobacco Use Disorder</mesh_term>
    <mesh_term>Bipolar Disorder</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acetylcysteine</mesh_term>
    <mesh_term>N-monoacetylcystine</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02252341
org study id: MP-007
nct id: NCT02252341
lead sponsor: 
has dmc: Yes
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
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 ) .
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: number cigarettes per day
time frame: baseline
measure: Carbon Oxide exhalation
time frame: basal, 1, 2 and 3 months
measure: Biological outcome measures
time frame: baseline and 3 months
description: inflammatory and oxidative stress biomarkers
arm group label: placebo
arm group type: Placebo Comparator
description: 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.
arm group label: N-Acetyl-Cysteine
arm group type: Placebo Comparator
description: 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 type: Dietary Supplement
intervention name: N-Acetyl-Cysteine
description: drug: N-Acetyl-cysteine N-Acetyl-cysteine 1800 mg a day for 12 weeks versus placebo for 12 weeks
arm group label: N-Acetyl-Cysteine
other name: N-acetyl-cysteine 1800 mg a day for 12 weeks or
other name: N-Acetyl-cysteine 3 pills/day for 12 weeks.
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Sandra Nunes, M.D, Ph.D
role: Study Chair
affiliation: Universidade Estadual de Londrina
facility: 
country: Brazil
url: http://www.dmd.uem.br
description: departement of medicine - state university of Maringá
responsible party type: Principal Investigator
investigator affiliation: Universidade Estadual de Maringá
investigator full name: Mauro Porcu
investigator title: Professor of Psychiatry
mesh term: Tobacco Use Disorder
mesh term: Bipolar Disorder
mesh term: Acetylcysteine
mesh term: N-monoacetylcystine