<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/NCT01710163</url>
  </required_header>
  <id_info>
    <org_study_id>ARIQUELI</org_study_id>
    <nct_id>NCT01710163</nct_id>
  </id_info>
  <brief_title>Potentiation of Quetiapine Treatment With Lithium or Aripiprazole in Bipolar 1 Nonresponders Patients</brief_title>
  <acronym>ARIQUELI</acronym>
  <official_title>ARIQUELI: Potentiation of Quetiapine Treatment in Bipolar 1 Nonresponders Patients With Lithium or Aripiprazole</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Sao Paulo</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Sao Paulo</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine whether Bipolar I Disorder refractory treatment&#xD;
      with Quetiapine monotherapy could be better potentiated with Lithium or Aripiprazole. The&#xD;
      investigators hypothesized that Lithium or Aripiprazole would provide similar compliance and&#xD;
      tolerability in maintenance treatment.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>June 2012</start_date>
  <completion_date type="Anticipated">June 2015</completion_date>
  <primary_completion_date type="Anticipated">June 2013</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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The main outcome will be the number of patients that achieve and remain in remission to each treatment at the end of each phase of the study</measure>
    <time_frame>2 years</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Bipolar I Disorder</condition>
  <arm_group>
    <arm_group_label>Lithium</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Potentiation of previous treatment (Quetiapine monotherapy) with Lithium (0.5 - 0.8 mEq/L)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Aripiprazole</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Potentiation of previous treatment (Quetiapine monotherapy) with Aripiprazole (10 - 15 mg)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lithium</intervention_name>
    <description>Starting at 300 mg daily, weekly dose will be adjusted according to blood serum level (between 0.5 -0.8mEq/l) according to efficacy and tolerability.</description>
    <arm_group_label>Lithium</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Aripiprazole</intervention_name>
    <description>Starting at 10 mg daily, dose will be adjusted up to 15 mg daily according to efficacy and tolerability.</description>
    <arm_group_label>Aripiprazole</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Clinical diagnosis of Bipolar Disorder, type I, in current episode (manic/hypomanic,&#xD;
             mixed or depression)&#xD;
&#xD;
          -  The patient or his (her) legal representative should understand the nature of the&#xD;
             study and sign the Informed Consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Schizophrenia or schizoaffective disorder&#xD;
&#xD;
          -  Mental retardation&#xD;
&#xD;
          -  Unstable clinical diseases&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ricardo Alberto Moreno, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Institute of Psychiatry, University of São Paulo</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Giovani Missio, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Institute of Psychiatry, University of São Paulo</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Giovani Missio</last_name>
    <phone>+ 55 11 2661 6648</phone>
    <email>gmissio@mac.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Ricardo Alberto Moreno, MD, PhD</last_name>
    <phone>+ 55 11 2661 6648</phone>
    <email>rmoreno@sti.com.br</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Institute of Psychiatry, University of São Paulo</name>
      <address>
        <city>São Paulo</city>
        <zip>05403-010</zip>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Giovani Missio</last_name>
      <phone>+55 11 26616648</phone>
      <email>gmissio@mac.com</email>
    </contact>
    <contact_backup>
      <last_name>Ricardo Alberto Moreno, MD, PhD</last_name>
      <phone>+55 11 26616648</phone>
      <email>rmoreno@sti.com.br</email>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>Institute of Psychiatry</name>
      <address>
        <city>São Paulo</city>
        <zip>05403010</zip>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Missio</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>October 2012</verification_date>
  <study_first_submitted>July 28, 2012</study_first_submitted>
  <study_first_submitted_qc>October 16, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 19, 2012</study_first_posted>
  <last_update_submitted>October 16, 2012</last_update_submitted>
  <last_update_submitted_qc>October 16, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 19, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Sao Paulo</investigator_affiliation>
    <investigator_full_name>Ricardo Alberto Moreno, M.D., Ph.D.</investigator_full_name>
    <investigator_title>MD PhD</investigator_title>
  </responsible_party>
  <keyword>Lithium Carbonate</keyword>
  <keyword>Lithium</keyword>
  <keyword>Central Nervous System Agents</keyword>
  <keyword>Therapeutic Uses</keyword>
  <keyword>Pharmacologic Actions</keyword>
  <keyword>Enzyme Inhibitors</keyword>
  <keyword>Molecular Mechanisms of Pharmacological Action</keyword>
  <keyword>Neurotransmitter Agents</keyword>
  <keyword>Physiological Effects of Drugs</keyword>
  <keyword>Antimanic Agents</keyword>
  <keyword>Tranquilizing Agents</keyword>
  <keyword>Central Nervous System Depressants</keyword>
  <keyword>Psychotropic Drugs</keyword>
  <keyword>Sensory System Agents</keyword>
  <keyword>Antipsychotic Agents</keyword>
  <keyword>Antidepressive Agents</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Aripiprazole</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/NCT01710163
org study id: ARIQUELI
nct id: NCT01710163
lead sponsor: 
has dmc: No
The purpose of this study is to determine whether Bipolar I Disorder refractory treatment
      with Quetiapine monotherapy could be better potentiated with Lithium or Aripiprazole. The
      investigators hypothesized that Lithium or Aripiprazole would provide similar compliance and
      tolerability in maintenance treatment.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: The main outcome will be the number of patients that achieve and remain in remission to each treatment at the end of each phase of the study
time frame: 2 years
arm group label: Lithium
arm group type: Experimental
description: Potentiation of previous treatment (Quetiapine monotherapy) with Lithium (0.5 - 0.8 mEq/L)
arm group label: Aripiprazole
arm group type: Experimental
description: Potentiation of previous treatment (Quetiapine monotherapy) with Aripiprazole (10 - 15 mg)
intervention type: Drug
intervention name: Lithium
description: Starting at 300 mg daily, weekly dose will be adjusted according to blood serum level (between 0.5 -0.8mEq/l) according to efficacy and tolerability.
arm group label: Lithium
intervention type: Drug
intervention name: Aripiprazole
description: Starting at 10 mg daily, dose will be adjusted up to 15 mg daily according to efficacy and tolerability.
arm group label: Aripiprazole
criteria: 
gender: All
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: No
last name: Ricardo Alberto Moreno, MD, PhD
role: Principal Investigator
affiliation: Institute of Psychiatry, University of São Paulo
last name: Giovani Missio, MD
role: Study Chair
affiliation: Institute of Psychiatry, University of São Paulo
last name: Giovani Missio
phone: + 55 11 2661 6648
email: gmissio@mac.com
last name: Ricardo Alberto Moreno, MD, PhD
phone: + 55 11 2661 6648
email: rmoreno@sti.com.br
facility: 
status: Recruiting
contact: 
contact backup: 
facility: 
status: Recruiting
contact: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: University of Sao Paulo
investigator full name: Ricardo Alberto Moreno, M.D., Ph.D.
investigator title: MD PhD
mesh term: Aripiprazole