Clinical trial NCT02213887: Study of the Effects of Pantoprazole on Levels of Prescribed Psychiatric Medications
Official title: A Pilot Study to Determine if Pantoprazole Modifies Steady-State Plasma Concentrations of Orally Administered Psychotropic Medications
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Psychotic Disorders
Gastroesophageal Reflux
Keywords: 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
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2014-08-12
Enrollment: 0
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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

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 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

Primary outcomes:
measure: Change from baseline in steady-state plasma concentrations of psychotropic medication(s) at Days 2, 5, and 9.
timeFrame: Days 1(baseline), 2 , 5, and 9
Secondary outcomes:
measure: Change from baseline in fasting serum gastrin concentrations at Day 9.
timeFrame: Days 1 (baseline) and 9
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: UBC Hospital - Detwiller Pavilion
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Ric M. Procyshyn, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: University of British Columbia
name: Alasdair Barr, Ph.D
role: STUDY_DIRECTOR
affiliation: University of British Columbia
name: William Honer, MD
role: STUDY_DIRECTOR
affiliation: University of British Columbia
name: Randall White, MD
role: STUDY_DIRECTOR
References: