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

• ClinicalTrials.gov Identifier: NCT02213887
• Recruitment Status: Withdrawn
• First Posted: August 12, 2014
• Last Update Posted: October 8, 2021
• Sponsor: University of British Columbia
• Information provided by (Responsible Party): Ric Procyshyn, University of British Columbia

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Psychotic Disorders; Gastroesophageal Reflux	Drug: Pantoprazole	Phase 4

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 0 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: A Pilot Study to Determine if Pantoprazole Modifies Steady-State Plasma Concentrations of Orally Administered Psychotropic Medications
• Study Start Date: September 2014
• Actual Primary Completion Date: November 2, 2020
• Actual Study Completion Date: November 2, 2020

Arms and Interventions

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
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; 0 mg PO QAM; Other Names: Pantoloc; Protonix

Outcome Measures

Primary Outcome Measures :

1. 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

Secondary Outcome Measures :

1. 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

Eligibility Criteria

• Ages Eligible for Study: 19 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

Canada, British Columbia

UBC Hospital - Detwiller Pavilion

Vancouver, British Columbia, Canada, V6T 2A1

Sponsors and Collaborators

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

More Information

• Responsible Party: Ric Procyshyn, Principle Investigator, University of British Columbia
• ClinicalTrials.gov Identifier: NCT02213887
• Other Study ID Numbers: H14-01095
• First Posted: August 12, 2014
• Last Update Posted: October 8, 2021
• Last Verified: October 2021

Keywords provided by Ric Procyshyn, University of British Columbia:

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

Additional relevant MeSH terms:

Gastroesophageal Reflux; Mental Disorders; Psychotic Disorders; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Schizophrenia Spectrum and Other Psychotic Disorders; Pantoprazole; Anti-Ulcer Agents; Gastrointestinal Agents; Proton Pump Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action