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Study of the Effects of Pantoprazole on Levels of Prescribed Psychiatric Medications (PK-PPI)

Primary Purpose

Psychotic Disorders, Gastroesophageal Reflux

Status
Withdrawn
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Pantoprazole
Pantoprazole
Sponsored by
University of British Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Psychotic Disorders focused on measuring Drug Interactions, Pantoprazole, Proton Pump Inhibitors, Psychotropic Drugs, Antipsychotic Agents, Aripiprazole, Asenapine, Clozapine, Lurasidone, Olanzapine, 9-hydroxy-risperidone, Quetiapine, Risperidone, Ziprasidone, Valproic Acid, Lithium, Gastrins, Psychotic Disorders, Gastroesophageal Reflux

Eligibility Criteria

19 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Participants must be fluent in English
  • Participants with a psychiatric diagnosis and currently treated with one or more of the following medications: valproic acid, lithium, or a second-generation antipsychotic (i.e., aripiprazole, asenapine, clozapine, lurasidone, olanzapine, paliperidone, quetiapine, risperidone, or ziprasidone)
  • Participants on a stable dose of valproic acid, lithium, and/or a second-generation antipsychotic for a sufficient period of time that ensures they are at steady state
  • Participants with symptoms of gastroesophageal reflux disease (GERD) that would benefit from treatment with pantoprazole or participants currently treated for GERD with pantoprazole for more than 8 weeks and are currently symptom free.

Exclusion Criteria:

  • Participants that are hypersensitive to pantoprazole
  • Pregnant or lactating women
  • Women of childbearing age not using reliable contraception
  • Any postsurgical complications of the gastrointestinal tract that might impair absorption
  • Clinically relevant abnormalities of laboratory parameters
  • Participants treated with another acid suppressing agent (e.g., H2 receptor antagonists, antacids, alginates, etc)
  • Participants treated with atazanavir, delavirdine, erlotinib, nelfinavir, and/or posaconazole

Sites / Locations

  • UBC Hospital - Detwiller Pavilion

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Start Pantoprazole

Stop Pantoprazole

Arm Description

Participants have been diagnosed with gastroesophageal reflux disease but have not started pharmacological treatment. Intervention: Days 2-8

Participants have been taking pantoprazole for more than 8 weeks and are asymptomatic for gastroesophageal reflux disease. Intervention: Days 2-8

Outcomes

Primary Outcome Measures

Change from baseline in steady-state plasma concentrations of psychotropic medication(s) at Days 2, 5, and 9.
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

Secondary Outcome Measures

Change from baseline in fasting serum gastrin concentrations at Day 9.
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

Full Information

First Posted
August 6, 2014
Last Updated
October 1, 2021
Sponsor
University of British Columbia
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1. Study Identification

Unique Protocol Identification Number
NCT02213887
Brief Title
Study of the Effects of Pantoprazole on Levels of Prescribed Psychiatric Medications
Acronym
PK-PPI
Official Title
A Pilot Study to Determine if Pantoprazole Modifies Steady-State Plasma Concentrations of Orally Administered Psychotropic Medications
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Withdrawn
Why Stopped
Unable to recruit participants
Study Start Date
September 2014 (undefined)
Primary Completion Date
November 2, 2020 (Actual)
Study Completion Date
November 2, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of British Columbia

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this 9-day study is to determine if: 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) Serum gastrin levels change within a week of starting or stopping pantoprazole
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychotic Disorders, Gastroesophageal Reflux
Keywords
Drug Interactions, Pantoprazole, Proton Pump Inhibitors, Psychotropic Drugs, Antipsychotic Agents, Aripiprazole, Asenapine, Clozapine, Lurasidone, Olanzapine, 9-hydroxy-risperidone, Quetiapine, Risperidone, Ziprasidone, Valproic Acid, Lithium, Gastrins, Psychotic Disorders, Gastroesophageal Reflux

7. Study Design

Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Start Pantoprazole
Arm Type
Experimental
Arm Description
Participants have been diagnosed with gastroesophageal reflux disease but have not started pharmacological treatment. Intervention: Days 2-8
Arm Title
Stop Pantoprazole
Arm Type
Experimental
Arm 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(s)
Pantoprazole
Other Intervention Name(s)
Pantoloc, Protonix
Intervention Description
40 mg PO QAM
Intervention Type
Drug
Intervention Name(s)
Pantoprazole
Other Intervention Name(s)
Pantoloc, Protonix
Intervention Description
0 mg PO QAM
Primary Outcome Measure Information:
Title
Change from baseline in steady-state plasma concentrations of psychotropic medication(s) at Days 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
Time Frame
Days 1(baseline), 2 , 5, and 9
Secondary Outcome Measure Information:
Title
Change from baseline in fasting serum gastrin concentrations at Day 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
Time Frame
Days 1 (baseline) and 9

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participants must be fluent in English Participants with a psychiatric diagnosis and currently treated with one or more of the following medications: valproic acid, lithium, or a second-generation antipsychotic (i.e., aripiprazole, asenapine, clozapine, lurasidone, olanzapine, paliperidone, quetiapine, risperidone, or ziprasidone) Participants on a stable dose of valproic acid, lithium, and/or a second-generation antipsychotic for a sufficient period of time that ensures they are at steady state Participants with symptoms of gastroesophageal reflux disease (GERD) that would benefit from treatment with pantoprazole or participants currently treated for GERD with pantoprazole for more than 8 weeks and are currently symptom free. Exclusion Criteria: Participants that are hypersensitive to pantoprazole Pregnant or lactating women Women of childbearing age not using reliable contraception Any postsurgical complications of the gastrointestinal tract that might impair absorption Clinically relevant abnormalities of laboratory parameters Participants treated with another acid suppressing agent (e.g., H2 receptor antagonists, antacids, alginates, etc) Participants treated with atazanavir, delavirdine, erlotinib, nelfinavir, and/or posaconazole
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ric M. Procyshyn, Ph.D
Organizational Affiliation
University of British Columbia
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Alasdair Barr, Ph.D
Organizational Affiliation
University of British Columbia
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
William Honer, MD
Organizational Affiliation
University of British Columbia
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Randall White, MD
Organizational Affiliation
University of British Columbia
Official's Role
Study Director
Facility Information:
Facility Name
UBC Hospital - Detwiller Pavilion
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6T 2A1
Country
Canada

12. IPD Sharing Statement

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Study of the Effects of Pantoprazole on Levels of Prescribed Psychiatric Medications

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