<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/NCT01674361</url>
  </required_header>
  <id_info>
    <org_study_id>WN28137</org_study_id>
    <nct_id>NCT01674361</nct_id>
  </id_info>
  <brief_title>A Study of Bitopertin (RO4917838) in Combination With Selective Serotonin Reuptake Inhibitors (SSRIs) in Participants With Obsessive-Compulsive Disorder (OCD)</brief_title>
  <official_title>A Phase II, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate Efficacy and Safety of RO4917838 in Combination With Selective Serotonin Reuptake Inhibitors in Patients With Obsessive Compulsive Disorder</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hoffmann-La Roche</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hoffmann-La Roche</source>
  <brief_summary>
    <textblock>
      This multicenter, randomized, double-blind, parallel-group, placebo-controlled study will&#xD;
      evaluate the efficacy and safety of bitopertin in combination with SSRI in participants with&#xD;
      obsessive-compulsive disorder. Participants will be randomized to receive either bitopertin&#xD;
      30 milligrams (mg) or bitopertin 10 mg or placebo orally daily in addition to their&#xD;
      background therapy with an SSRI. Participants will be allocated to one of two strata.&#xD;
      Participants in Stratum 1 will start study drug on Day 1. Participants in Stratum 2 will&#xD;
      receive placebo from Day 1 (placebo lead-in) and will then start study drug at the Week 2&#xD;
      visit. Participants in both strata will receive the study drug in addition to their&#xD;
      background therapy with an SSRI until Week 16.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 31, 2012</start_date>
  <completion_date type="Actual">April 30, 2015</completion_date>
  <primary_completion_date type="Actual">April 30, 2015</primary_completion_date>
  <phase>Phase 2</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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change From Baseline in Total Score on Yale-Brown Obsessive Compulsive Scale (Y-BOCS) After 12 Weeks of Treatment</measure>
    <time_frame>Stratum 1: Baseline (Day 1), Week 12; Stratum 2: Baseline (Week 2), Week 14</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Clinical Global Impression of Severity (CGI-S) Score After 12 Weeks of Treatment</measure>
    <time_frame>Stratum 1: Baseline (Day 1), Week 12; Stratum 2: Baseline (Week 2), Week 14</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants with Response as per Pre-defined Criteria Based on the Y-BOCS and CGI</measure>
    <time_frame>Stratum 1: Baseline (Day 1) up to Week 12; Stratum 2: Baseline (Week 2) up to Week 14</time_frame>
    <description>Response will be defined as having:&#xD;
At least a 35 percent (%) reduction on the total Y-BOCS score from baseline. A much or very much improved on the Clinical Global Impression of Change (CGI-C) rating from baseline.&#xD;
A combination of at least 35% reduction on the total Y-BOCS score from baseline and much or very much improved on the CGI-C from baseline.&#xD;
Achieved remission, as shown by a total Y-BOCS score less than or equal to (≤)10.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Global Social Functioning Using Sheehan Disability Scale (SDS) Total Score After 12 Weeks of Treatment</measure>
    <time_frame>Stratum 1: Baseline (Day 1), Week 12; Stratum 2: Baseline (Week 2), Week 14</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Global Social Functioning Using SDS Domain Scores After 12 Weeks of Treatment</measure>
    <time_frame>Stratum 1: Baseline (Day 1) up to Week 12; Stratum 2: Baseline (Week 2) up to Week 14</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Obsessive Compulsive Inventory-Revised (OCI-R) Score After 12 Weeks of Treatment</measure>
    <time_frame>Stratum 1: Baseline (Day 1) up to Week 12; Stratum 2: Baseline (Week 2) up to Week 14</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Columbia Suicide Severity Rating Scale After 12 Weeks of Treatment</measure>
    <time_frame>Stratum 1: Baseline (Day 1) up to Week 12; Stratum 2: Baseline (Week 2) up to Week 14</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in 36-Item Short-Form Health Survey (SF-36) - Mental Component Summary After 12 Weeks of Treatment</measure>
    <time_frame>Stratum 1: Baseline (Day 1) up to Week 12; Stratum 2: Baseline (Week 2) up to Week 14</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in SF-36 - Physical Component Summary After 12 Weeks of Treatment</measure>
    <time_frame>Stratum 1: Baseline (Day 1) up to Week 12; Stratum 2: Baseline (Week 2) up to Week 14</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in SF-36 - Domain Scores After 12 Weeks of Treatment</measure>
    <time_frame>Stratum 1: Baseline (Day 1) up to Week 12; Stratum 2: Baseline (Week 2) up to Week 14</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area Under The Concentration-Time Curve of Bitopertin</measure>
    <time_frame>Pre-dose (0 hour) on Day 56 (Week 8), Day 84 (Week 12), Day 98 (Week 14), Day 112 (Week 16); 3 and 6 hours post-dose on Day 112 (Week 16)</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">99</enrollment>
  <condition>Obsessive-Compulsive Disorder</condition>
  <arm_group>
    <arm_group_label>Bitopertin 30 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants in Stratum 1 will receive bitopertin 30 mg from Day 1 to Week 16 in addition to their background therapy with an SSRI.&#xD;
Participants in Stratum 2 will receive placebo from Day 1 and will then start bitopertin 30 mg at the Week 2 until Week 16 in addition to their background therapy with an SSRI.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Bitopertin 10 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants in Stratum 1 will receive bitopertin 10 mg from Day 1 to Week 16 in addition to their background therapy with an SSRI.&#xD;
Participants in Stratum 2 will receive placebo from Day 1 and will then start bitopertin 10 mg at the Week 2 until Week 16 in addition to their background therapy with an SSRI.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants (both Stratum 1 and Stratum 2) will receive placebo from Day 1 to Week 16 in addition to their background therapy with an SSRI.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bitopertin</intervention_name>
    <description>Bitopertin once daily orally.</description>
    <arm_group_label>Bitopertin 10 mg</arm_group_label>
    <arm_group_label>Bitopertin 30 mg</arm_group_label>
    <other_name>RO4917838</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo matched to bitopertin once daily orally.</description>
    <arm_group_label>Bitopertin 10 mg</arm_group_label>
    <arm_group_label>Bitopertin 30 mg</arm_group_label>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>SSRI</intervention_name>
    <description>Participants will continue their background SSRI treatment as per standard of care at the same dose taken during the 8 weeks prior to Day 1. Protocol does not enforce any particular SSRI drug or regimen.</description>
    <arm_group_label>Bitopertin 10 mg</arm_group_label>
    <arm_group_label>Bitopertin 30 mg</arm_group_label>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Primary diagnosis of OCD as per Diagnostic and Statistical Manual of Mental Disorders,&#xD;
             Fourth Edition, Text Revision (DSM-IV-TR)&#xD;
&#xD;
          -  On a stable dose of SSRI for at least 8 weeks prior to screening an between screening&#xD;
             and Day 1&#xD;
&#xD;
          -  An insufficient response to current treatment with an SSRI given at an adequate dose&#xD;
             for at least 12 weeks prior to Day 1&#xD;
&#xD;
          -  Females who are not postmenopausal or surgically sterile and who have (or may have)&#xD;
             male sexual partners must agree to use two adequate methods of contraception as&#xD;
             defined by protocol from the start of screening until 90 days after the last dose of&#xD;
             study drug&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Primary OCD symptom of hoarding&#xD;
&#xD;
          -  More than two unsatisfactory trials within the last 2 years with different serotonin&#xD;
             reuptake inhibitors (not including the current treatment with an SSRI) given in an&#xD;
             adequate dose for at least 12 weeks&#xD;
&#xD;
          -  Failure of more than three augmentation therapies within the last 2 years&#xD;
&#xD;
          -  Undergoing acute behavioral therapy or having acute behavioral therapy that was&#xD;
             completed less than 4 weeks prior to Day 1&#xD;
&#xD;
          -  Any primary DSM-IV-TR Axis I disorder other than OCD&#xD;
&#xD;
          -  Current or prior history of bipolar disorder, schizophrenia or other psychotic&#xD;
             disorders, schizoaffective disorder, autism or autistic spectrum disorders, borderline&#xD;
             personality disorder, or Gilles de la Tourette syndrome if symptoms have persisted&#xD;
             into adulthood&#xD;
&#xD;
          -  Any eating disorder within the last 6 months&#xD;
&#xD;
          -  History of DSM-IV-TR-defined substance dependence and/or substance abuse in the last 6&#xD;
             months, with the exception of nicotine&#xD;
&#xD;
          -  Previous treatment with bitopertin or another Glycine transporter 1 inhibitor&#xD;
&#xD;
          -  Positive urine drug screening for cannabis, amphetamines (including&#xD;
             3,4-methylenedioxymethamphetamine [MDMA]/ecstasy), cocaine, barbiturate, and/or&#xD;
             opiates&#xD;
&#xD;
          -  Prior or current general medical condition that may impair cognition or other&#xD;
             neuropsychiatric functioning&#xD;
&#xD;
          -  Body mass index less than (&lt;) 18.5 kilogram per square meter (kg/m^2) or greater than&#xD;
             (&gt;) 40 kg/m^2&#xD;
&#xD;
          -  Pregnant or lactating women&#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>Clinical Trials</last_name>
    <role>Study Director</role>
    <affiliation>Hoffmann-La Roche</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Excell Research</name>
      <address>
        <city>Oceanside</city>
        <state>California</state>
        <zip>92056</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Stanford University School of Medicine</name>
      <address>
        <city>Stanford</city>
        <state>California</state>
        <zip>94305</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Yale University School of Medicine; Neuroscience Research Training Program</name>
      <address>
        <city>New Haven</city>
        <state>Connecticut</state>
        <zip>06519</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Compass Research North, LLC</name>
      <address>
        <city>Leesburg</city>
        <state>Florida</state>
        <zip>34748</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical Research Group of Central Florida</name>
      <address>
        <city>Orange City</city>
        <state>Florida</state>
        <zip>3273</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of South Florida</name>
      <address>
        <city>Saint Petersburg</city>
        <state>Florida</state>
        <zip>33701</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of South Florida</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33613-4706</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>iResearch Atlanta</name>
      <address>
        <city>Decatur</city>
        <state>Georgia</state>
        <zip>30030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Carman Research</name>
      <address>
        <city>Smyrna</city>
        <state>Georgia</state>
        <zip>30080</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Uni of Chicago; Centre For Advanced Medicine</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60637</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Louisiana Research Associates</name>
      <address>
        <city>New Orleans</city>
        <state>Louisiana</state>
        <zip>70114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Massachusetts General Hospital - East</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Boston Clinical Trials</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02131</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ambulatory Research Center (ARC), Department of Psychiatry</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55454</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Precise Research Centers</name>
      <address>
        <city>Flowood</city>
        <state>Mississippi</state>
        <zip>39232</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St Louis Clinical Trials</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63141</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mount Sinai School of Medicine; Department of Psychiatry</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10029</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical Research Network - New York</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10128</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Finger Lakes Clinical Research</name>
      <address>
        <city>Rochester</city>
        <state>New York</state>
        <zip>14618</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>North Star Research</name>
      <address>
        <city>Middleburg Heights</city>
        <state>Ohio</state>
        <zip>44130</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ips Research Company</name>
      <address>
        <city>Oklahoma City</city>
        <state>Oklahoma</state>
        <zip>73103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Keystone Clinical Studies, LLC</name>
      <address>
        <city>Norristown</city>
        <state>Pennsylvania</state>
        <zip>19403</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Butler Hospital - Department of Psychiatry and Human Behavior</name>
      <address>
        <city>Providence</city>
        <state>Rhode Island</state>
        <zip>02906</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Neuroscience Solutions,Inc</name>
      <address>
        <city>Memphis</city>
        <state>Tennessee</state>
        <zip>38119</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>FutureSearch Trials, LP</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78731</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Eastside Therapeutic Resource</name>
      <address>
        <city>Kirkland</city>
        <state>Washington</state>
        <zip>98033</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dean Foundation</name>
      <address>
        <city>Middleton</city>
        <state>Wisconsin</state>
        <zip>53562</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chokka Center for Integrative Health</name>
      <address>
        <city>Edmonton</city>
        <state>Alberta</state>
        <zip>T6L 6W6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Okanagan Clinical Trials</name>
      <address>
        <city>Kelowna</city>
        <state>British Columbia</state>
        <zip>V1Y 2H4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>True North Clinical Research-Halifax</name>
      <address>
        <city>Halifax</city>
        <state>Nova Scotia</state>
        <zip>B3S 1M7</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>True North Clinical Research Kentville</name>
      <address>
        <city>Kentville</city>
        <state>Nova Scotia</state>
        <zip>B4N 4K9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>McMaster University - MacAnxiety Research Centre</name>
      <address>
        <city>Hamilton</city>
        <state>Ontario</state>
        <zip>L8S 1B7</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sunny Johnson Medical Research Associates Inc.; Medical Research Associates</name>
      <address>
        <city>Mississauga</city>
        <state>Ontario</state>
        <zip>L5M 4N4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>START Clinic for Mood &amp; Anxiety Disorders</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M4W 2N4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>August 15, 2012</study_first_submitted>
  <study_first_submitted_qc>August 24, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 28, 2012</study_first_posted>
  <disposition_first_submitted>September 10, 2013</disposition_first_submitted>
  <disposition_first_submitted_qc>July 10, 2017</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">July 12, 2017</disposition_first_posted>
  <last_update_submitted>July 31, 2017</last_update_submitted>
  <last_update_submitted_qc>July 31, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 2, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </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>
  <!-- Results have not yet been posted, but a results disposition has been submitted           -->
</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/NCT01674361
org study id: WN28137
nct id: NCT01674361
lead sponsor: 
This multicenter, randomized, double-blind, parallel-group, placebo-controlled study will
      evaluate the efficacy and safety of bitopertin in combination with SSRI in participants with
      obsessive-compulsive disorder. Participants will be randomized to receive either bitopertin
      30 milligrams (mg) or bitopertin 10 mg or placebo orally daily in addition to their
      background therapy with an SSRI. Participants will be allocated to one of two strata.
      Participants in Stratum 1 will start study drug on Day 1. Participants in Stratum 2 will
      receive placebo from Day 1 (placebo lead-in) and will then start study drug at the Week 2
      visit. Participants in both strata will receive the study drug in addition to their
      background therapy with an SSRI until Week 16.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Change From Baseline in Total Score on Yale-Brown Obsessive Compulsive Scale (Y-BOCS) After 12 Weeks of Treatment
time frame: Stratum 1: Baseline (Day 1), Week 12; Stratum 2: Baseline (Week 2), Week 14
measure: Change From Baseline in Clinical Global Impression of Severity (CGI-S) Score After 12 Weeks of Treatment
time frame: Stratum 1: Baseline (Day 1), Week 12; Stratum 2: Baseline (Week 2), Week 14
measure: Percentage of Participants with Response as per Pre-defined Criteria Based on the Y-BOCS and CGI
time frame: Stratum 1: Baseline (Day 1) up to Week 12; Stratum 2: Baseline (Week 2) up to Week 14
description: Response will be defined as having:
At least a 35 percent (%) reduction on the total Y-BOCS score from baseline. A much or very much improved on the Clinical Global Impression of Change (CGI-C) rating from baseline.
A combination of at least 35% reduction on the total Y-BOCS score from baseline and much or very much improved on the CGI-C from baseline.
Achieved remission, as shown by a total Y-BOCS score less than or equal to (≤)10.
measure: Change From Baseline in Global Social Functioning Using Sheehan Disability Scale (SDS) Total Score After 12 Weeks of Treatment
time frame: Stratum 1: Baseline (Day 1), Week 12; Stratum 2: Baseline (Week 2), Week 14
measure: Change From Baseline in Global Social Functioning Using SDS Domain Scores After 12 Weeks of Treatment
time frame: Stratum 1: Baseline (Day 1) up to Week 12; Stratum 2: Baseline (Week 2) up to Week 14
measure: Change From Baseline in Obsessive Compulsive Inventory-Revised (OCI-R) Score After 12 Weeks of Treatment
time frame: Stratum 1: Baseline (Day 1) up to Week 12; Stratum 2: Baseline (Week 2) up to Week 14
measure: Change From Baseline in Columbia Suicide Severity Rating Scale After 12 Weeks of Treatment
time frame: Stratum 1: Baseline (Day 1) up to Week 12; Stratum 2: Baseline (Week 2) up to Week 14
measure: Change From Baseline in 36-Item Short-Form Health Survey (SF-36) - Mental Component Summary After 12 Weeks of Treatment
time frame: Stratum 1: Baseline (Day 1) up to Week 12; Stratum 2: Baseline (Week 2) up to Week 14
measure: Change From Baseline in SF-36 - Physical Component Summary After 12 Weeks of Treatment
time frame: Stratum 1: Baseline (Day 1) up to Week 12; Stratum 2: Baseline (Week 2) up to Week 14
measure: Change From Baseline in SF-36 - Domain Scores After 12 Weeks of Treatment
time frame: Stratum 1: Baseline (Day 1) up to Week 12; Stratum 2: Baseline (Week 2) up to Week 14
measure: Area Under The Concentration-Time Curve of Bitopertin
time frame: Pre-dose (0 hour) on Day 56 (Week 8), Day 84 (Week 12), Day 98 (Week 14), Day 112 (Week 16); 3 and 6 hours post-dose on Day 112 (Week 16)
arm group label: Bitopertin 30 mg
arm group type: Experimental
description: Participants in Stratum 1 will receive bitopertin 30 mg from Day 1 to Week 16 in addition to their background therapy with an SSRI.
Participants in Stratum 2 will receive placebo from Day 1 and will then start bitopertin 30 mg at the Week 2 until Week 16 in addition to their background therapy with an SSRI.
arm group label: Bitopertin 10 mg
arm group type: Experimental
description: Participants in Stratum 1 will receive bitopertin 10 mg from Day 1 to Week 16 in addition to their background therapy with an SSRI.
Participants in Stratum 2 will receive placebo from Day 1 and will then start bitopertin 10 mg at the Week 2 until Week 16 in addition to their background therapy with an SSRI.
arm group label: Placebo
arm group type: Placebo Comparator
description: Participants (both Stratum 1 and Stratum 2) will receive placebo from Day 1 to Week 16 in addition to their background therapy with an SSRI.
intervention type: Drug
intervention name: Bitopertin
description: Bitopertin once daily orally.
arm group label: Bitopertin 10 mg
arm group label: Bitopertin 30 mg
other name: RO4917838
intervention type: Drug
intervention name: Placebo
description: Placebo matched to bitopertin once daily orally.
arm group label: Bitopertin 10 mg
arm group label: Bitopertin 30 mg
arm group label: Placebo
intervention type: Drug
intervention name: SSRI
description: Participants will continue their background SSRI treatment as per standard of care at the same dose taken during the 8 weeks prior to Day 1. Protocol does not enforce any particular SSRI drug or regimen.
arm group label: Bitopertin 10 mg
arm group label: Bitopertin 30 mg
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Clinical Trials
role: Study Director
affiliation: Hoffmann-La Roche
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country: Canada
country: United States
responsible party type: Sponsor
mesh term: Compulsive Personality Disorder
mesh term: Obsessive-Compulsive Disorder