<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/NCT02194075</url>
  </required_header>
  <id_info>
    <org_study_id>B2013006</org_study_id>
    <nct_id>NCT02194075</nct_id>
  </id_info>
  <brief_title>Methylphenidate Hydrochloride Controlled-Release Tablets Augmentation Strategy for Patients With Obsessive Compulsive Disorder</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Guangdong Provincial People's Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Guangdong Provincial People's Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Explore the efficacy of methylphenidate hydrochloride controlled-release tablets add-on&#xD;
      pharmacotherapy on clinical symptomatology and cognitive functioning in a sample of patients&#xD;
      with obsessive-compulsive disorder (OCD) receiving fluvoxamine maleate. To test the&#xD;
      hypothesis that methylphenidate hydrochloride controlled-release tablets augmentation of&#xD;
      fluvoxamine treatment is well tolerated and may be proposed as an effective therapeutic&#xD;
      strategy to improve outcome in OCD.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2013</start_date>
  <completion_date type="Actual">October 2015</completion_date>
  <primary_completion_date type="Actual">October 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>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Yale-Brown Obsessive Compulsive Scale (Y-BOCS)</measure>
    <time_frame>8 weeks</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Obsessive Compulsive Disorder</condition>
  <arm_group>
    <arm_group_label>Fluvoxamine+Methylphenidate Hydrochloride</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Fluvoxamine: tablet, 100mg-300mg/d, were treated with a course of 8 weeks.&#xD;
Methylphenidate Hydrochloride: tablet, 18mg-36mg/d, were treated with a course of 8 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Fluvoxamine+sugar pill</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Fluvoxamine: tablet, 100mg-300mg/d, were treated with a course of 8 weeks.&#xD;
sugar pill: tablet, 1-2 tablets/d, were treated with a course of 8 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Fluvoxamine+Methylphenidate hydrochloride</intervention_name>
    <arm_group_label>Fluvoxamine+Methylphenidate Hydrochloride</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Fluvoxamine+sugar pill</intervention_name>
    <arm_group_label>Fluvoxamine+sugar pill</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Informed consent&#xD;
&#xD;
          -  Met DSM-V criteria&#xD;
&#xD;
          -  Y-BOCS ≥ 16&#xD;
&#xD;
          -  Course of illness ≥ 1year&#xD;
&#xD;
          -  Age range between 18~40 years old&#xD;
&#xD;
          -  Junior high school education level above&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any other psychiatric axis-I or axis-II disorders&#xD;
&#xD;
          -  History of epileptic seizures or any other neurological disorder&#xD;
&#xD;
          -  Any other clinically relevant abnormalities in their medical history or laboratory&#xD;
             examinations; alcohol or drug abuser&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Guangdong General Hospital, Guangdong academy of medical science</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510180</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>December 2013</verification_date>
  <study_first_submitted>July 11, 2014</study_first_submitted>
  <study_first_submitted_qc>July 17, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 18, 2014</study_first_posted>
  <last_update_submitted>October 22, 2015</last_update_submitted>
  <last_update_submitted_qc>October 22, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 23, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Guangdong Provincial People's Hospital</investigator_affiliation>
    <investigator_full_name>sunnyrong</investigator_full_name>
    <investigator_title>MD,PHD</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Compulsive Personality Disorder</mesh_term>
    <mesh_term>Obsessive-Compulsive Disorder</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fluvoxamine</mesh_term>
    <mesh_term>Methylphenidate</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/NCT02194075
org study id: B2013006
nct id: NCT02194075
lead sponsor: 
has dmc: Yes
Explore the efficacy of methylphenidate hydrochloride controlled-release tablets add-on
      pharmacotherapy on clinical symptomatology and cognitive functioning in a sample of patients
      with obsessive-compulsive disorder (OCD) receiving fluvoxamine maleate. To test the
      hypothesis that methylphenidate hydrochloride controlled-release tablets augmentation of
      fluvoxamine treatment is well tolerated and may be proposed as an effective therapeutic
      strategy to improve outcome in OCD.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Yale-Brown Obsessive Compulsive Scale (Y-BOCS)
time frame: 8 weeks
arm group label: Fluvoxamine+Methylphenidate Hydrochloride
arm group type: Active Comparator
description: Fluvoxamine: tablet, 100mg-300mg/d, were treated with a course of 8 weeks.
Methylphenidate Hydrochloride: tablet, 18mg-36mg/d, were treated with a course of 8 weeks.
arm group label: Fluvoxamine+sugar pill
arm group type: Placebo Comparator
description: Fluvoxamine: tablet, 100mg-300mg/d, were treated with a course of 8 weeks.
sugar pill: tablet, 1-2 tablets/d, were treated with a course of 8 weeks.
intervention type: Drug
intervention name: Fluvoxamine+Methylphenidate hydrochloride
arm group label: Fluvoxamine+Methylphenidate Hydrochloride
intervention type: Drug
intervention name: Fluvoxamine+sugar pill
arm group label: Fluvoxamine+sugar pill
criteria: 
gender: All
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: No
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Guangdong Provincial People's Hospital
investigator full name: sunnyrong
investigator title: MD,PHD
mesh term: Compulsive Personality Disorder
mesh term: Obsessive-Compulsive Disorder
mesh term: Fluvoxamine
mesh term: Methylphenidate