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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Psychotic Disorders, Gastroesophageal Reflux

Intervention / Treatment
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* Drug: Pantoprazole
* Drug: Pantoprazole


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Start Pantoprazole<br>Participants have been diagnosed with gastroesophageal reflux disease but have not started pharmacological treatment. Intervention: Days 2-8 | Drug: Pantoprazole<br>* 40 mg PO QAM<br>* Other names: Protonix;|
| Experimental: Stop Pantoprazole<br>Participants have been taking pantoprazole for more than 8 weeks and are asymptomatic for gastroesophageal reflux disease. Intervention: Days 2-8 | Drug: Pantoprazole<br>* 0 mg PO QAM<br>* Other names: Protonix;|

What is the study measuring?
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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. | 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. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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