<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/NCT03780595</url>
  </required_header>
  <id_info>
    <org_study_id>SEDISTRESS</org_study_id>
    <nct_id>NCT03780595</nct_id>
  </id_info>
  <brief_title>Passiflora Extract for Benzodiazepine Withdrawal</brief_title>
  <acronym>SEDISTRESS</acronym>
  <official_title>Efficacy and Safety of the Administration of the Passiflora Extract for Benzodiazepine Withdrawal in Institutionalized Older Adults: Clinical Trial Phase III</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nutricion Medica S.L.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Nutricion Medica S.L.</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>
      The aim of this clinical trials is compare the percentage of patient who achieve a reduction&#xD;
      equal to or greater than 50% in the dose of benzodiazepines at 10 weeks of treatment.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">September 27, 2018</start_date>
  <completion_date type="Anticipated">December 31, 2019</completion_date>
  <primary_completion_date type="Anticipated">June 30, 2019</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>To compare the percentage of patients who achieve to reduce the dose of benzodiazepines equal or more than 50% Reduction of the benzodiazepine dose</measure>
    <time_frame>10 weeks of treatment</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">108</enrollment>
  <condition>Benzodiazepine Withdrawal (Disorder)</condition>
  <arm_group>
    <arm_group_label>Passiflora</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Passiflora incarnata</intervention_name>
    <description>Passiflora pills administration up to 6 pills per day</description>
    <arm_group_label>Passiflora</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Control</intervention_name>
    <description>Control pills administration up to 6 pills per day</description>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age &gt; 65 years old&#xD;
&#xD;
          2. Stable dose of benzodiazepines during last 3 months ( 4mg loracepam per day or&#xD;
             equivalent)&#xD;
&#xD;
          3. Capable of giving consent and to answer the questionnaires according to researcher&#xD;
             criteria&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Diagnosis of dementia moderate or severe (Test Minimental ≤ 20).&#xD;
&#xD;
          2. Acute confusional syndrome at the inclusion&#xD;
&#xD;
          3. Panic disorder&#xD;
&#xD;
          4. Obsesive-compulsive disorder&#xD;
&#xD;
          5. Any type of psycosis or bipolar disorder&#xD;
&#xD;
          6. Severe Parkison disease diagnosed&#xD;
&#xD;
          7. Current or past diagnosis of epilepsia&#xD;
&#xD;
          8. Recent stroke (last month)&#xD;
&#xD;
          9. Thyroid disorders not controlled or uncompensated&#xD;
&#xD;
         10. Alteration of deglutition&#xD;
&#xD;
         11. Previous drugs or alcohol abuse&#xD;
&#xD;
         12. Hospitalization (more than 24 hours) during the last month&#xD;
&#xD;
         13. Complex priority treatment (dialisis, chemotherapy...)&#xD;
&#xD;
         14. Life expectation less than 1 year&#xD;
&#xD;
         15. Benzodiazepines therapeutic uses not for anxiety or insomnio&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Luis Fernando Agüera</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital Universitario 12 de Octubre</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>María de Andres</last_name>
    <phone>+34 913 14 92 71</phone>
    <email>mariade.andres@nutricionmedica.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Residencia Albertia Moratalaz</name>
      <address>
        <city>Madrid</city>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Macarena Maroto Algarra, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Residencia Amavir Ciudad Lineal</name>
      <address>
        <city>Madrid</city>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Carmen Figueroa Linki, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Residencia Nogales Imperial</name>
      <address>
        <city>Madrid</city>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Silvia Mallón Redondo, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Residencia Nogales Pontones</name>
      <address>
        <city>Madrid</city>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Carmela Mañas Martínez, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Residencia Nogales Puerta de Hierro</name>
      <address>
        <city>Madrid</city>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Adriá León García, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Residencia Albertia Valle de la Oliva</name>
      <address>
        <city>Majadahonda</city>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Liliana González Espinosa, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Residencia Amavir San Agustín</name>
      <address>
        <city>San Agustín del Guadalix</city>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jorge Luis Cañón, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Residencia Amavir Torrejón</name>
      <address>
        <city>Torrejón De Ardoz</city>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sara González Blazquez, MD</last_name>
    </contact>
    <investigator>
      <last_name>May Ling Carmiña Rodríguez, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 18, 2018</study_first_submitted>
  <study_first_submitted_qc>December 18, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 19, 2018</study_first_posted>
  <last_update_submitted>December 18, 2018</last_update_submitted>
  <last_update_submitted_qc>December 18, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 19, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Benzodiazepine</keyword>
  <keyword>Withdrawal</keyword>
  <keyword>passiflora</keyword>
  <!-- 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/NCT03780595
org study id: SEDISTRESS
nct id: NCT03780595
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of this clinical trials is compare the percentage of patient who achieve a reduction
      equal to or greater than 50% in the dose of benzodiazepines at 10 weeks of treatment.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: To compare the percentage of patients who achieve to reduce the dose of benzodiazepines equal or more than 50% Reduction of the benzodiazepine dose
time frame: 10 weeks of treatment
arm group label: Passiflora
arm group type: Experimental
arm group label: Control
arm group type: Placebo Comparator
intervention type: Drug
intervention name: Passiflora incarnata
description: Passiflora pills administration up to 6 pills per day
arm group label: Passiflora
intervention type: Drug
intervention name: Control
description: Control pills administration up to 6 pills per day
arm group label: Control
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: No
last name: Luis Fernando Agüera
role: Principal Investigator
affiliation: Hospital Universitario 12 de Octubre
last name: María de Andres
phone: +34 913 14 92 71
email: mariade.andres@nutricionmedica.com
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
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status: Recruiting
contact: 
investigator: 
country: Spain
responsible party type: Sponsor