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
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