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

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ClinicalTrials.gov Identifier: NCT02213887
Recruitment Status : Unknown
Verified November 2017 by Ric Procyshyn, University of British Columbia.
Recruitment status was:  Active, not recruiting
First Posted : August 12, 2014
Last Update Posted : November 29, 2017
Sponsor:
Information provided by (Responsible Party):
Ric Procyshyn, University of British Columbia

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, 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

Condition or disease Intervention/treatment Phase
Psychotic Disorders Gastroesophageal Reflux Drug: Pantoprazole Phase 4

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. 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 220 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A Pilot Study to Determine if Pantoprazole Modifies Steady-State Plasma Concentrations of Orally Administered Psychotropic Medications
Study Start Date : September 2014
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : August 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD

Arm Intervention/treatment
Experimental: Start Pantoprazole

Participants have been diagnosed with gastroesophageal reflux disease but have not started pharmacological treatment.

Intervention: Days 2-8

Drug: Pantoprazole
40 mg PO QAM
Other Names:
  • Pantoloc
  • Protonix

Experimental: Stop Pantoprazole

Participants have been taking pantoprazole for more than 8 weeks and are asymptomatic for gastroesophageal reflux disease.

Intervention: Days 2-8

Drug: Pantoprazole
0 mg PO QAM
Other Names:
  • Pantoloc
  • Protonix




Primary Outcome Measures :
  1. Change from baseline in steady-state plasma concentrations of psychotropic medication(s) at Days 2, 5, and 9. [ Time Frame: Days 1(baseline), 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


Secondary Outcome Measures :
  1. Change from baseline in fasting serum gastrin concentrations at Day 9. [ Time Frame: Days 1 (baseline) and 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



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Ages Eligible for Study:   19 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02213887


Locations
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Canada, British Columbia
UBC Hospital - Detwiller Pavilion
Vancouver, British Columbia, Canada, V6T 2A1
Sponsors and Collaborators
University of British Columbia
Investigators
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Principal Investigator: Ric M. Procyshyn, Ph.D University of British Columbia
Study Director: 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

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Responsible Party: Ric Procyshyn, Principle Investigator, University of British Columbia
ClinicalTrials.gov Identifier: NCT02213887     History of Changes
Other Study ID Numbers: H14-01095
First Posted: August 12, 2014    Key Record Dates
Last Update Posted: November 29, 2017
Last Verified: November 2017
Keywords provided by Ric Procyshyn, University of British Columbia:
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
Additional relevant MeSH terms:
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Gastroesophageal Reflux
Mental Disorders
Psychotic Disorders
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Schizophrenia Spectrum and Other Psychotic Disorders
Risperidone
Pantoprazole
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors