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

NCT02213887 | Withdrawn Phase 4

• 1 other identifier: H14-01095
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this 9-day study is to determine if:

1. 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. 2.Serum gastrin levels change within a week of starting or stopping pantoprazole

Conditions

Psychotic Disorders; Gastroesophageal Reflux

Keywords

Drug Interactions; Pantoprazole; Proton Pump Inhibitors; Psychotropic Drugs; Antipsychotic Agents; Aripiprazole; Asenapine; Clozapine; Lurasidone; Olanzapine; 9-hydroxy-risperidone; Quetiapine; Risperidone; Ziprasidone; Valproic Acid; Lithium; Gastrins; Psychotic Disorders; Gastroesophageal Reflux

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change from baseline in fasting serum gastrin concentrations at Day 9.

  Days 1 (baseline) and 9

Study Arms (2)

Start Pantoprazole

EXPERIMENTAL

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

Drug: Pantoprazole

Stop Pantoprazole

EXPERIMENTAL

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

Drug: Pantoprazole

Interventions

Pantoprazole DRUG

40 mg PO QAM

Also known as: Pantoloc, Protonix

Start Pantoprazole

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

UBC Hospital - Detwiller Pavilion

Vancouver, British Columbia, V6T 2A1, Canada

Location

MeSH Terms

Conditions

Psychotic Disorders; Gastroesophageal Reflux

Interventions

Pantoprazole

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Ric M. Procyshyn, Ph.D

  University of British Columbia

  PRINCIPAL INVESTIGATOR

• Alasdair Barr, Ph.D

  University of British Columbia

  STUDY DIRECTOR

• William Honer, MD

  University of British Columbia

  STUDY DIRECTOR

• Randall White, MD

  University of British Columbia

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: August 6, 2014
• First Posted: August 12, 2014
• Study Start: September 1, 2014
• Primary Completion: November 2, 2020
• Study Completion: November 2, 2020
• Last Updated: October 8, 2021

Record last verified: 2021-10

Locations

CA (1)