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

Psychotic Disorders Clinical Trial

— PK-PPI  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02213887
• Other study ID #: H14-01095
• Status: Withdrawn
• Phase: Phase 4
• Start date: September 2014
• Est. completion date: November 2, 2020

Study information

• Verified date: October 2021
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 2, 2020
• Est. primary completion date: November 2, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Gastroesophageal Reflux
• Mental Disorders
• Psychotic Disorders

Intervention

Drug:
• Pantoprazole
40 mg PO QAM
• Pantoprazole
0 mg PO QAM

Locations

Country	Name	City	State
Canada	UBC Hospital - Detwiller Pavilion	Vancouver	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
University of British Columbia

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in steady-state plasma concentrations of psychotropic medication(s) at Days 2, 5, and 9.	Pharmacokinetic outcome measures often require multiple measurement over time. On Day 1, baseline steady-state plasma concentration of psychotropic medication(s) will be determined. On Days 2, 5, and 9, steady-state plasma concentration of psychotropic medication(s) will be determined and compared to baseline	Days 1(baseline), 2 , 5, and 9
Secondary	Change from baseline in fasting serum gastrin concentrations at Day 9.	On Day 1, baseline fasting serum gastrin concentration will be determined. On Day 9, fasting serum gastrin concentration will be determined and compared to baseline	Days 1 (baseline) and 9