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

Sponsor

University of British Columbia (Other)

Overall Status

Withdrawn

CT.gov ID

NCT02213887

Collaborator

(none)

Enrollment

Location

Arms

74.1

Duration (Months)

Patients Per Site Per Month

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Psychotic Disorders Gastroesophageal Reflux	Drug: Pantoprazole 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

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 :

Sep 1, 2014

Actual Primary Completion Date :

Nov 2, 2020

Actual Study Completion Date :

Nov 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

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

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

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

Criteria

Ages Eligible for Study:

19 Years to 65 Years

Sexes Eligible for Study:

All

Accepts 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