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

Information source: University of British Columbia
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Psychotic Disorders; Gastroesophageal Reflux

Intervention: Pantoprazole (Drug); Pantoprazole (Drug)

Phase: Phase 4

Status: Enrolling by invitation

Sponsored by: University of British Columbia

Official(s) and/or principal investigator(s):
Ric M. Procyshyn, Ph.D, Principal Investigator, Affiliation: University of British Columbia
Alasdair Barr, Ph.D, Study Director, Affiliation: University of British Columbia
William Honer, MD, Study Director, Affiliation: University of British Columbia
Randall White, MD, Study Director, Affiliation: University of British Columbia

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

Clinical Details

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

Study design: Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label

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

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

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.

Eligibility

Minimum age: 19 Years. Maximum age: 65 Years. Gender(s): Both.

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

Locations and Contacts

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

Starting date: September 2014
Last updated: November 4, 2014

Page last updated: August 23, 2015

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