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

• Status: Withdrawn
• Trial end date: 2020-11-02
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of British Columbia
• Treatments: Pantoprazole; Psychotropic Drugs; Risperidone

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