Psychotic DisordersPhase 4PK-PPINCT02213887
Study of the Effects of Pantoprazole on Levels of Prescribed Psychiatric Medications
A Phase 4 study testing Pantoprazole in people with Psychotic Disorders and Gastroesophageal Reflux, run by University of British Columbia at 1 site in Canada.
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… Read more about this study
- Who is it for?
- Ages 19 to 65 years
- Conditions the study is for
- Psychotic Disorders, Gastroesophageal Reflux
- What is being tested?
- Pantoprazole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2014to 2 Nov 2020
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Canada1 site
UBC Hospital - Detwiller Pavilion
Vancouver, British Columbia, V6T 2A1
About this study
Official title: A Pilot Study to Determine if Pantoprazole Modifies Steady-State Plasma Concentrations of Orally Administered Psychotropic Medications
The purpose of this 9-day study is to determine if:
- 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)
- Serum gastrin levels change within a week of starting or stopping pantoprazole
Read the 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.
- Conditions
- Psychotic Disorders, Gastroesophageal Reflux
- Being tested
- Pantoprazole
- 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
- Medical subject headings
- Psychotic Disorders, Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PantoprazoleDrug
Also called Pantoloc, Protonix
40 mg PO QAM
PantoprazoleDrug
Also called Pantoloc, Protonix
0 mg PO QAM
| Study group | Role | What they receive |
|---|---|---|
| Start Pantoprazole | Experimental | Participants have been diagnosed with gastroesophageal reflux disease but have not started pharmacological treatment.
Intervention: Days 2-8 Receives: 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 Receives: Drug: Pantoprazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Days 1(baseline), 2 , 5, and 9
Secondary outcomes (1)
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
Measured: Days 1 (baseline) and 9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2014 (estimated)
- Study startSep 2014
- Primary completion2 Nov 2020
- Study completion2 Nov 2020
Why it stopped: Unable to recruit participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychotic DisordersStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ric Procyshyn, University of British Columbia
- Investigators
- Ric M. Procyshyn, Ph.D, Principal investigator, University of British ColumbiaAlasdair Barr, Ph.D, Study director, University of British ColumbiaWilliam Honer, MD, Study director, University of British ColumbiaRandall White, MD, Study director, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02213887
- Sponsor's protocol ID
- H14-01095
- Acronym
- PK-PPI
- Status last verified
- Oct 2021
- First submitted
- 6 Aug 2014
- Last updated
- 8 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Determine if Pantoprazole Modifies Steady-State Plasma Concentrations of Orally Administered Psychotropic Medications
- ClinicalTrials.gov ID
- NCT02213887
- Acronym / sponsor ID
- PK-PPI / H14-01095
- Conditions
- Psychotic Disorders, Gastroesophageal Reflux
- Keywords
- Drug Interactions, Pantoprazole, Proton Pump Inhibitors, Psychotropic Drugs, Antipsychotic Agents, Aripiprazole, Asenapine, Clozapine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Unable to recruit participants
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- 2 Nov 2020 (actual)
- Study completion
- 2 Nov 2020 (actual)
- First posted
- 12 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this 9-day study is to determine if:
- 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)
- Serum gastrin levels change within a week of starting or stopping pantoprazole
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Start Pantoprazole | Experimental | Drug: PantoprazoleParticipants have been diagnosed with gastroesophageal reflux disease but have not started pharmacological treatment. Intervention: Days 2-8 |
| Stop Pantoprazole | Experimental | Drug: PantoprazoleParticipants have been taking pantoprazole for more than 8 weeks and are asymptomatic for gastroesophageal reflux disease. Intervention: Days 2-8 |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PantoprazoleAlso: Pantoloc, Protonix40 mg PO QAM | Drug | Start Pantoprazole |
| PantoprazoleAlso: Pantoloc, Protonix0 mg PO QAM | Drug | Stop Pantoprazole |
Primary outcome
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
1 secondary outcome
Change from baseline in fasting serum gastrin concentrations at Day 9.
Time frame: Days 1 (baseline) and 9
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ric M. Procyshyn, Ph.D principal investigator
University of British Columbia
Alasdair Barr, Ph.D study director
University of British Columbia
William Honer, MD study director
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Pantoprazole in people with Psychotic Disorders and Gastroesophageal Reflux, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 8 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2021.