Study of the Effects of Pantoprazole on Levels of Prescribed Psychiatric Medications (PK-PPI)

University of British Columbia

Status and phase: Withdrawn; Phase 4

Conditions: Psychotic Disorders; Gastroesophageal Reflux

Treatments: Drug: Pantoprazole

Study type: Interventional

Funder types: Other

Identifiers

NCT02213887

H14-01095

Details and patient eligibility

About

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

Full 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.

Sex: All

Ages: 19 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Start Pantoprazole

Experimental group

Description:

Participants have been diagnosed with gastroesophageal reflux disease but have not started pharmacological treatment. Intervention: Days 2-8

Treatment:

Drug: Pantoprazole

Drug: Pantoprazole

Stop Pantoprazole

Experimental group

Description:

Participants have been taking pantoprazole for more than 8 weeks and are asymptomatic for gastroesophageal reflux disease. Intervention: Days 2-8

Treatment:

Drug: Pantoprazole

Drug: Pantoprazole