<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/NCT03227562</url>
  </required_header>
  <id_info>
    <org_study_id>2016-000341-31</org_study_id>
    <nct_id>NCT03227562</nct_id>
  </id_info>
  <brief_title>Is Initial Response to Low Dose Risperidone Predictive for Outcome in Anxiety?</brief_title>
  <official_title>Evaluation of Predictability of the Initial Response to a Low Dose of Risperidone on the Middle Term Efficiency in Anxious Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Marion Trousselard</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Institut de Recherche Biomedicale des Armees</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Risperidone at low dosage is often used as treatment of acute anxiety symptom. However,&#xD;
      patients may be either responder or not. Here we hypothesized that the early response to a&#xD;
      low dose of risperidone is predictive to risperidone efficiency.&#xD;
&#xD;
      Subjects with acute anxiety symptoms (Hospital anxiety depression scale) and risperidone&#xD;
      prescription would be proposed to be enrolled in the study. A check-up is made at D0, then&#xD;
      the subjects begin the treatment (0.5mg risperidone). The same check-up is carried out on the&#xD;
      following day (D1). The subjects fulfil a last check-up 12 week after the beginning of&#xD;
      treatment (W12). During the D1-W12, the psychiatrist may changes the treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Risperidone at low dosage is often used as treatment of acute anxiety symptom. However,&#xD;
      patients may be either responder or not. Here we hypothesized that the early response to a&#xD;
      low dose of risperidone is predictive to risperidone efficiency.&#xD;
&#xD;
      Subjects with acute anxiety symptoms (Hospital anxiety depression scale) and risperidone&#xD;
      prescription would be proposed to be enrolled in the study. After acceptation, the fulfil&#xD;
      questionnaires (MINI, PCL-s-V) then they interacts with test on computers (PVT, 2nBack, Iowa&#xD;
      gambling task) and give saliva and receive an actimetric watch (D0).&#xD;
&#xD;
      They begin the treatment on the evening (0.5mg risperidone/day). The following day, they come&#xD;
      back to hospital and they fulfil the same tests, questionnaires and samples (D1).&#xD;
&#xD;
      12 week after, they come again to hospital to fulfil the same tests, questionnaires and&#xD;
      samples (W12).&#xD;
&#xD;
      Between D1 and S12, the psychiatrist may change the treatment, adding other treatment or&#xD;
      modifying risperidone treatment (increasing dosage up to 2mg/day or removing it).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    not enough patient&#xD;
  </why_stopped>
  <start_date type="Actual">September 1, 2017</start_date>
  <completion_date type="Actual">December 1, 2021</completion_date>
  <primary_completion_date type="Actual">September 1, 2021</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>All subjects are under 0.5mg risperidone (one group). Accordin to their response to treatment (responder vs. non responder) the 2 experimental groups will be created.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Anxiety</measure>
    <time_frame>changes between baseline and day 1 and between baseline and week 12</time_frame>
    <description>score in Anxiety scale in the Hospital Anxiety Depression Scale (HADs)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Type of anxiety</measure>
    <time_frame>changes between baseline and day 1 and between baseline and week 12</time_frame>
    <description>score in the Post-trauma CheckList 5</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Cognition</measure>
    <time_frame>changes between baseline and day 1 and between baseline and week 12</time_frame>
    <description>score in the Iowa Gambling Task</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">120</enrollment>
  <condition>Anxiety State</condition>
  <arm_group>
    <arm_group_label>Responder</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>The 2 arms will be created according to the early response to risperidone (responder vs. non responder)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Non responder</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>The 2 arms will be created according to the early response to risperidone (responder vs. non responder)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>RisperiDONE 0.5 MG</intervention_name>
    <description>To be prescribed a 0.5mg risperidone treatment for anxiety is required to be enrolled.</description>
    <arm_group_label>Non responder</arm_group_label>
    <arm_group_label>Responder</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  anxiety (score above 11 at anxiety scale of HADs)&#xD;
&#xD;
          -  To have a prescription for 0.5 mg risperidone/day&#xD;
&#xD;
          -  To give the consent&#xD;
&#xD;
          -  To have a social protection&#xD;
&#xD;
          -  To be adult (18-50 years)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Psychiatric antecedents&#xD;
&#xD;
          -  any treatment for mental disease (antidepressant, anxiolytics, etc.)&#xD;
&#xD;
          -  Ongoing neurological pathologies&#xD;
&#xD;
          -  Scheduled surgery&#xD;
&#xD;
          -  addiction&#xD;
&#xD;
          -  pregancy&#xD;
&#xD;
          -  known intolerance to risperidone&#xD;
&#xD;
          -  participation to another biomedical study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bertrand Lahutte</last_name>
    <role>Principal Investigator</role>
    <affiliation>HIA Begin Paris</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Marion Trousselard</name>
      <address>
        <city>Brétigny-sur-Orge</city>
        <state>Not In US/Canada</state>
        <zip>91223</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>July 14, 2017</study_first_submitted>
  <study_first_submitted_qc>July 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 24, 2017</study_first_posted>
  <last_update_submitted>August 2, 2022</last_update_submitted>
  <last_update_submitted_qc>August 2, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 4, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Institut de Recherche Biomedicale des Armees</investigator_affiliation>
    <investigator_full_name>Marion Trousselard</investigator_full_name>
    <investigator_title>professor</investigator_title>
  </responsible_party>
  <keyword>risperidone</keyword>
  <keyword>anxiety</keyword>
  <keyword>cognition</keyword>
  <keyword>stress</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anxiety Disorders</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Risperidone</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03227562
org study id: 2016-000341-31
nct id: NCT03227562
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Risperidone at low dosage is often used as treatment of acute anxiety symptom. However,
      patients may be either responder or not. Here we hypothesized that the early response to a
      low dose of risperidone is predictive to risperidone efficiency.

      Subjects with acute anxiety symptoms (Hospital anxiety depression scale) and risperidone
      prescription would be proposed to be enrolled in the study. A check-up is made at D0, then
      the subjects begin the treatment (0.5mg risperidone). The same check-up is carried out on the
      following day (D1). The subjects fulfil a last check-up 12 week after the beginning of
      treatment (W12). During the D1-W12, the psychiatrist may changes the treatment.
Risperidone at low dosage is often used as treatment of acute anxiety symptom. However,
      patients may be either responder or not. Here we hypothesized that the early response to a
      low dose of risperidone is predictive to risperidone efficiency.

      Subjects with acute anxiety symptoms (Hospital anxiety depression scale) and risperidone
      prescription would be proposed to be enrolled in the study. After acceptation, the fulfil
      questionnaires (MINI, PCL-s-V) then they interacts with test on computers (PVT, 2nBack, Iowa
      gambling task) and give saliva and receive an actimetric watch (D0).

      They begin the treatment on the evening (0.5mg risperidone/day). The following day, they come
      back to hospital and they fulfil the same tests, questionnaires and samples (D1).

      12 week after, they come again to hospital to fulfil the same tests, questionnaires and
      samples (W12).

      Between D1 and S12, the psychiatrist may change the treatment, adding other treatment or
      modifying risperidone treatment (increasing dosage up to 2mg/day or removing it).
allocation: Non-Randomized
intervention model: Single Group Assignment
intervention model description: All subjects are under 0.5mg risperidone (one group). Accordin to their response to treatment (responder vs. non responder) the 2 experimental groups will be created.
primary purpose: Treatment
masking: None (Open Label)
measure: Anxiety
time frame: changes between baseline and day 1 and between baseline and week 12
description: score in Anxiety scale in the Hospital Anxiety Depression Scale (HADs)
measure: Type of anxiety
time frame: changes between baseline and day 1 and between baseline and week 12
description: score in the Post-trauma CheckList 5
measure: Cognition
time frame: changes between baseline and day 1 and between baseline and week 12
description: score in the Iowa Gambling Task
arm group label: Responder
arm group type: Other
description: The 2 arms will be created according to the early response to risperidone (responder vs. non responder)
arm group label: Non responder
arm group type: Other
description: The 2 arms will be created according to the early response to risperidone (responder vs. non responder)
intervention type: Drug
intervention name: RisperiDONE 0.5 MG
description: To be prescribed a 0.5mg risperidone treatment for anxiety is required to be enrolled.
arm group label: Non responder
arm group label: Responder
criteria: 
gender: All
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: No
last name: Bertrand Lahutte
role: Principal Investigator
affiliation: HIA Begin Paris
facility: 
country: France
responsible party type: Sponsor-Investigator
investigator affiliation: Institut de Recherche Biomedicale des Armees
investigator full name: Marion Trousselard
investigator title: professor
mesh term: Anxiety Disorders
mesh term: Risperidone
sharing ipd: Undecided