Status:
WITHDRAWN
Study of the Effects of Pantoprazole on Levels of Prescribed Psychiatric Medications
Lead Sponsor:
University of British Columbia
Conditions:
Psychotic Disorders
Gastroesophageal Reflux
Eligibility:
All Genders
19-65 years
Phase:
PHASE4
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, a...
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. Co...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 2 2020
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT02213887
Start Date
September 1 2014
End Date
November 2 2020
Last Update
October 8 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
UBC Hospital - Detwiller Pavilion
Vancouver, British Columbia, Canada, V6T 2A1