NCT02213887

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

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

• Status: Withdrawn
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of British Columbia · Academic / Other
• Sex: All
• Age: 19 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Psychotic Disorders
• Gastroesophageal Reflux

Interventions

Type	Name	Description
DRUG	Pantoprazole	40 mg PO QAM
DRUG	Pantoprazole	0 mg PO QAM

Timeline

• Start date: 2014-09-01
• Primary completion: 2020-11-02
• Completion: 2020-11-02
• First posted: 2014-08-12
• Last updated: 2021-10-08

Locations

1 site across 1 country: Canada