<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/NCT02213887</url>
  </required_header>
  <id_info>
    <org_study_id>H14-01095</org_study_id>
    <nct_id>NCT02213887</nct_id>
  </id_info>
  <brief_title>Study of the Effects of Pantoprazole on Levels of Prescribed Psychiatric Medications</brief_title>
  <acronym>PK-PPI</acronym>
  <official_title>A Pilot Study to Determine if Pantoprazole Modifies Steady-State Plasma Concentrations of Orally Administered Psychotropic Medications</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of British Columbia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of British Columbia</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this 9-day study is to determine if:&#xD;
&#xD;
        1. Pantoprazole modifies the steady-state plasma concentrations of orally administered&#xD;
           psychotropic medications including valproic acid, lithium, and second-generation&#xD;
           antipsychotics (i.e., aripiprazole, asenapine, clozapine, lurasidone, olanzapine,&#xD;
           paliperidone, quetiapine, risperidone, ziprasidone)&#xD;
&#xD;
        2. Serum gastrin levels change within a week of starting or stopping pantoprazole&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Individuals with psychiatric diagnoses may be predisposed to gastroesophageal reflux disease&#xD;
      because of the widespread use of alcohol, cigarettes, and certain psychotropic drugs in this&#xD;
      population. Consequently, they are often prescribed proton pump inhibitors. To our knowledge,&#xD;
      no studies have been conducted to determine the effects of proton pump inhibitors on plasma&#xD;
      levels of psychotropic drugs. The present clinical study will assess the effects of&#xD;
      pantoprazole on the pharmacokinetics of valproic acid, lithium, and second-generation&#xD;
      antipsychotics.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Unable to recruit participants&#xD;
  </why_stopped>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">November 2, 2020</completion_date>
  <primary_completion_date type="Actual">November 2, 2020</primary_completion_date>
  <phase>Phase 4</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>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline in steady-state plasma concentrations of psychotropic medication(s) at Days 2, 5, and 9.</measure>
    <time_frame>Days 1(baseline), 2 , 5, and 9</time_frame>
    <description>Pharmacokinetic outcome measures often require multiple measurement over time. On Day 1, baseline steady-state plasma concentration of psychotropic medication(s) will be determined. On Days 2, 5, and 9, steady-state plasma concentration of psychotropic medication(s) will be determined and compared to baseline</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in fasting serum gastrin concentrations at Day 9.</measure>
    <time_frame>Days 1 (baseline) and 9</time_frame>
    <description>On Day 1, baseline fasting serum gastrin concentration will be determined. On Day 9, fasting serum gastrin concentration will be determined and compared to baseline</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Psychotic Disorders</condition>
  <condition>Gastroesophageal Reflux</condition>
  <arm_group>
    <arm_group_label>Start Pantoprazole</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants have been diagnosed with gastroesophageal reflux disease but have not started pharmacological treatment.&#xD;
Intervention: Days 2-8</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Stop Pantoprazole</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants have been taking pantoprazole for more than 8 weeks and are asymptomatic for gastroesophageal reflux disease.&#xD;
Intervention: Days 2-8</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Pantoprazole</intervention_name>
    <description>40 mg PO QAM</description>
    <arm_group_label>Start Pantoprazole</arm_group_label>
    <other_name>Pantoloc</other_name>
    <other_name>Protonix</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Pantoprazole</intervention_name>
    <description>0 mg PO QAM</description>
    <arm_group_label>Stop Pantoprazole</arm_group_label>
    <other_name>Pantoloc</other_name>
    <other_name>Protonix</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participants must be fluent in English&#xD;
&#xD;
          -  Participants with a psychiatric diagnosis and currently treated with one or more of&#xD;
             the following medications: valproic acid, lithium, or a second-generation&#xD;
             antipsychotic (i.e., aripiprazole, asenapine, clozapine, lurasidone, olanzapine,&#xD;
             paliperidone, quetiapine, risperidone, or ziprasidone)&#xD;
&#xD;
          -  Participants on a stable dose of valproic acid, lithium, and/or a second-generation&#xD;
             antipsychotic for a sufficient period of time that ensures they are at steady state&#xD;
&#xD;
          -  Participants with symptoms of gastroesophageal reflux disease (GERD) that would&#xD;
             benefit from treatment with pantoprazole or participants currently treated for GERD&#xD;
             with pantoprazole for more than 8 weeks and are currently symptom free.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participants that are hypersensitive to pantoprazole&#xD;
&#xD;
          -  Pregnant or lactating women&#xD;
&#xD;
          -  Women of childbearing age not using reliable contraception&#xD;
&#xD;
          -  Any postsurgical complications of the gastrointestinal tract that might impair&#xD;
             absorption&#xD;
&#xD;
          -  Clinically relevant abnormalities of laboratory parameters&#xD;
&#xD;
          -  Participants treated with another acid suppressing agent (e.g., H2 receptor&#xD;
             antagonists, antacids, alginates, etc)&#xD;
&#xD;
          -  Participants treated with atazanavir, delavirdine, erlotinib, nelfinavir, and/or&#xD;
             posaconazole&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ric M. Procyshyn, Ph.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of British Columbia</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Alasdair Barr, Ph.D</last_name>
    <role>Study Director</role>
    <affiliation>University of British Columbia</affiliation>
  </overall_official>
  <overall_official>
    <last_name>William Honer, MD</last_name>
    <role>Study Director</role>
    <affiliation>University of British Columbia</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Randall White, MD</last_name>
    <role>Study Director</role>
    <affiliation>University of British Columbia</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UBC Hospital - Detwiller Pavilion</name>
      <address>
        <city>Vancouver</city>
        <state>British Columbia</state>
        <zip>V6T 2A1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>October 2021</verification_date>
  <study_first_submitted>August 6, 2014</study_first_submitted>
  <study_first_submitted_qc>August 7, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 12, 2014</study_first_posted>
  <last_update_submitted>October 1, 2021</last_update_submitted>
  <last_update_submitted_qc>October 1, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 8, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of British Columbia</investigator_affiliation>
    <investigator_full_name>Ric Procyshyn</investigator_full_name>
    <investigator_title>Principle Investigator</investigator_title>
  </responsible_party>
  <keyword>Drug Interactions</keyword>
  <keyword>Pantoprazole</keyword>
  <keyword>Proton Pump Inhibitors</keyword>
  <keyword>Psychotropic Drugs</keyword>
  <keyword>Antipsychotic Agents</keyword>
  <keyword>Aripiprazole</keyword>
  <keyword>Asenapine</keyword>
  <keyword>Clozapine</keyword>
  <keyword>Lurasidone</keyword>
  <keyword>Olanzapine</keyword>
  <keyword>9-hydroxy-risperidone</keyword>
  <keyword>Quetiapine</keyword>
  <keyword>Risperidone</keyword>
  <keyword>Ziprasidone</keyword>
  <keyword>Valproic Acid</keyword>
  <keyword>Lithium</keyword>
  <keyword>Gastrins</keyword>
  <keyword>Psychotic Disorders</keyword>
  <keyword>Gastroesophageal Reflux</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Gastroesophageal Reflux</mesh_term>
    <mesh_term>Mental Disorders</mesh_term>
    <mesh_term>Psychotic Disorders</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pantoprazole</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/NCT02213887
org study id: H14-01095
nct id: NCT02213887
lead sponsor: 
has dmc: No
The purpose of this 9-day study is to determine if:

        1. Pantoprazole modifies the steady-state plasma concentrations of orally administered
           psychotropic medications including valproic acid, lithium, and second-generation
           antipsychotics (i.e., aripiprazole, asenapine, clozapine, lurasidone, olanzapine,
           paliperidone, quetiapine, risperidone, ziprasidone)

        2. Serum gastrin levels change within a week of starting or stopping pantoprazole
Individuals with psychiatric diagnoses may be predisposed to gastroesophageal reflux disease
      because of the widespread use of alcohol, cigarettes, and certain psychotropic drugs in this
      population. Consequently, they are often prescribed proton pump inhibitors. To our knowledge,
      no studies have been conducted to determine the effects of proton pump inhibitors on plasma
      levels of psychotropic drugs. The present clinical study will assess the effects of
      pantoprazole on the pharmacokinetics of valproic acid, lithium, and second-generation
      antipsychotics.
allocation: Non-Randomized
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Change from baseline in steady-state plasma concentrations of psychotropic medication(s) at Days 2, 5, and 9.
time frame: Days 1(baseline), 2 , 5, and 9
description: Pharmacokinetic outcome measures often require multiple measurement over time. On Day 1, baseline steady-state plasma concentration of psychotropic medication(s) will be determined. On Days 2, 5, and 9, steady-state plasma concentration of psychotropic medication(s) will be determined and compared to baseline
measure: Change from baseline in fasting serum gastrin concentrations at Day 9.
time frame: Days 1 (baseline) and 9
description: On Day 1, baseline fasting serum gastrin concentration will be determined. On Day 9, fasting serum gastrin concentration will be determined and compared to baseline
arm group label: Start Pantoprazole
arm group type: Experimental
description: Participants have been diagnosed with gastroesophageal reflux disease but have not started pharmacological treatment.
Intervention: Days 2-8
arm group label: Stop Pantoprazole
arm group type: Experimental
description: Participants have been taking pantoprazole for more than 8 weeks and are asymptomatic for gastroesophageal reflux disease.
Intervention: Days 2-8
intervention type: Drug
intervention name: Pantoprazole
description: 40 mg PO QAM
arm group label: Start Pantoprazole
other name: Pantoloc
other name: Protonix
intervention type: Drug
intervention name: Pantoprazole
description: 0 mg PO QAM
arm group label: Stop Pantoprazole
other name: Pantoloc
other name: Protonix
criteria: 
gender: All
minimum age: 19 Years
maximum age: 65 Years
healthy volunteers: No
last name: Ric M. Procyshyn, Ph.D
role: Principal Investigator
affiliation: University of British Columbia
last name: Alasdair Barr, Ph.D
role: Study Director
affiliation: University of British Columbia
last name: William Honer, MD
role: Study Director
affiliation: University of British Columbia
last name: Randall White, MD
role: Study Director
affiliation: University of British Columbia
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: University of British Columbia
investigator full name: Ric Procyshyn
investigator title: Principle Investigator
mesh term: Gastroesophageal Reflux
mesh term: Mental Disorders
mesh term: Psychotic Disorders
mesh term: Pantoprazole