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The purpose of this 9-day study is to determine if:
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Start Pantoprazole | Experimental | Participants have been diagnosed with gastroesophageal reflux disease but have not started pharmacological treatment. Intervention: Days 2-8 |
|
| Stop Pantoprazole | Experimental | Participants have been taking pantoprazole for more than 8 weeks and are asymptomatic for gastroesophageal reflux disease. Intervention: Days 2-8 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pantoprazole | Drug | 40 mg PO QAM |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UBC Hospital - Detwiller Pavilion | Vancouver | British Columbia | V6T 2A1 | Canada |
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| ID | Term |
|---|---|
| D011618 | Psychotic Disorders |
| D005764 | Gastroesophageal Reflux |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
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| ID | Term |
|---|---|
| D000077402 | Pantoprazole |
| ID | Term |
|---|---|
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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| Pantoprazole | Drug | 0 mg PO QAM |
|
|
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D011725 |
| Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |