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

October 1, 2021 updated by: Ric Procyshyn, University of British Columbia

A Pilot Study to Determine if Pantoprazole Modifies Steady-State Plasma Concentrations of Orally Administered Psychotropic Medications

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

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V6T 2A1
        • UBC Hospital - Detwiller Pavilion

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

17 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Start Pantoprazole

Participants have been diagnosed with gastroesophageal reflux disease but have not started pharmacological treatment.

Intervention: Days 2-8
Drug: Pantoprazole
40 mg PO QAM
Other Names:
  • Pantoloc
  • Protonix
Drug: Pantoprazole
0 mg PO QAM
Other Names:
  • Pantoloc
  • Protonix
Experimental: Stop Pantoprazole

Participants have been taking pantoprazole for more than 8 weeks and are asymptomatic for gastroesophageal reflux disease.

Intervention: Days 2-8
Drug: Pantoprazole
40 mg PO QAM
Other Names:
  • Pantoloc
  • Protonix
Drug: Pantoprazole
0 mg PO QAM
Other Names:
  • Pantoloc
  • Protonix

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
Days 1(baseline), 2 , 5, and 9

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in fasting serum gastrin concentrations at Day 9.
Time Frame: Days 1 (baseline) and 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
Days 1 (baseline) and 9

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of British Columbia

Investigators

  • Principal Investigator: Ric M. Procyshyn, Ph.D, University of British Columbia
  • Study Director: Alasdair Barr, Ph.D, University of British Columbia
  • Study Director: William Honer, MD, University of British Columbia
  • Study Director: Randall White, MD, University of British Columbia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (Actual)

November 2, 2020

Study Completion (Actual)

November 2, 2020

Study Registration Dates

First Submitted

August 6, 2014

First Submitted That Met QC Criteria

August 7, 2014

First Posted (Estimate)

August 12, 2014

Study Record Updates

Last Update Posted (Actual)

October 8, 2021

Last Update Submitted That Met QC Criteria

October 1, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H14-01095

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Psychotic Disorders

Clinical Trials on Pantoprazole

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Spain

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe