SchizophreniaPhase 4NCT03333603
Pharmacokinetics and Safety Studies of Esomeprazole Use in Schizophrenia Patients
A Phase 4 study testing esomeprazole in people with Schizophrenia, run by National Taiwan University Hospital at 2 sites in Taiwan.
Trial summary
To evaluate the pharmacokinetic and safety for the esomeprazole use for schizophrenia Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- esomeprazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 2 sitesTaiwan
- Study dates
- 23 May 2016to 23 Jan 2017
- 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 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 20-65 years old
- Diagnosed as DSM-IV schizophrenia
- No adjustment of dose of major antipsychotics for at least 4 weeks
- Competence for inform consent
Who cannot join
- Diagnosed with schizoaffective disorder or bipolar affective disorder or organic psychotic disorder
- Meet the diagnostic criteria of any substance abuse or dependence in the past 6 months
- History or evidence of any clinically significant medical or neurological disease, such as autoimmune disease, cancer, epilepsy, etc.
- Mental retardation or pervasive developmental disorders
- Past history of allergy to Esomeprazole
- patient who is taking clozapine、 Depakin or Diazepam
- Pregnant
- The patient is under the order of involuntary admission
Trial locations and contacts
2 sites in 1 country.
Taiwan2 sites
National Taiwan University Hospital
Taipei, 10048
National Taiwan University Hospital Yunlin Branch
Taipei
About this study
Official title: Pharmacokinetics and Safety Studies of Esomeprazole Use in Schizophrenic Patients
To evaluate the pharmacokinetic and safety for the esomeprazole use for schizophrenia
Read the detailed description
Investigators prepare to recruit 30 schizophrenia patients in one year. Investigators will conduct a 8-week open label clinical trial for evaluation of the pharmacokinetic and safety of esomeprazole use for the schizophrenia. Investigators will give 40 mg/day esomeprazole in the first two weeks and 80 mg/day from the third week to the end of the trial. Investigators will check the area under the concentration of metabolites of esomeprazole on Day 1, Day 14 and Day 56 and the genotype of CYP2C19. The GI symptoms and related drug side effects will be evaluated.
- Conditions
- Schizophrenia
- Being tested
- esomeprazole
- Keywords
- Schizophrenia
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
esomeprazoleDrug
Also called Nexium
esomeprazole 40mg /tab oral Day1-Day14 then 40mg/2 tab oral Day15-Day56
| Study group | Role | What they receive |
|---|---|---|
| esomeprazole | Experimental | esomeprazole 40mg /tab oral Day1-Day14 then 40mg/2 tab oral Day15-Day56 Receives: Drug: esomeprazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma Concentration analysis
The pharmacokinetic parameters for esomeprazole and its main metabolites
Measured: It will be assessed on Day 1 predose, Day 14 90 mins post dose, and Day 56 90 mins post dose
Secondary outcomes (1)
CYP2C19 genotypes analysis
Investigators will genotype CYP2C19 genotype to determine that which metabolized type (poor metabolizer, intermediate metabolizer, and good metabolizer) of patients belong to.
Measured: The genotype will be assessed on Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2017
- Study start23 May 2016
- Primary completion23 Jan 2017
- Study completion23 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Investigators will give 40 mg/day esomeprazole in the first two weeks and 80 mg/day from the third week to the end of the trial. Investigators will check the area under the concentration of metabolites of esomeprazoleon Day 1, Day 14 and Day 56 and the genotype of CYP2C19. The GI symptoms and related drug side effects will be evaluated.
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Taiwan University
- Responsible party
- Sponsor
- Investigators
- Chih-Min Liu, Principal investigator, Visiting Staff
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03333603
- Sponsor's protocol ID
- 201601070MIND
- Status last verified
- Jan 2017
- First submitted
- 17 Jan 2017
- Last updated
- 29 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics and Safety Studies of Esomeprazole Use in Schizophrenic Patients
- ClinicalTrials.gov ID
- NCT03333603
- Acronym / sponsor ID
- 201601070MIND
- Conditions
- Schizophrenia
- Keywords
- Schizophrenia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Collaborators
- National Taiwan University
- Study start
- 23 May 2016 (actual)
- Primary completion
- 23 Jan 2017 (actual)
- Study completion
- 23 Jan 2017 (actual)
- First posted
- 7 Nov 2017 (actual)
- 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.
To evaluate the pharmacokinetic and safety for the esomeprazole use for schizophrenia
Detailed description
Investigators prepare to recruit 30 schizophrenia patients in one year. Investigators will conduct a 8-week open label clinical trial for evaluation of the pharmacokinetic and safety of esomeprazole use for the schizophrenia. Investigators will give 40 mg/day esomeprazole in the first two weeks and 80 mg/day from the third week to the end of the trial. Investigators will check the area under the concentration of metabolites of esomeprazole on Day 1, Day 14 and Day 56 and the genotype of CYP2C19. The GI symptoms and related drug side effects will be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Investigators will give 40 mg/day esomeprazole in the first two weeks and 80 mg/day from the third week to the end of the trial. Investigators will check the area under the concentration of metabolites of esomeprazoleon Day 1, Day 14 and Day 56 and the genotype of CYP2C19. The GI symptoms and related drug side effects will be evaluated.
| Arm | Type | Receives |
|---|---|---|
| esomeprazole | Experimental | Drug: esomeprazoleesomeprazole 40mg /tab oral Day1-Day14 then 40mg/2 tab oral Day15-Day56 |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 20-65 years old
- Diagnosed as DSM-IV schizophrenia
- No adjustment of dose of major antipsychotics for at least 4 weeks
- Competence for inform consent
Key exclusion criteria (8 listed)
- Diagnosed with schizoaffective disorder or bipolar affective disorder or organic psychotic disorder
- Meet the diagnostic criteria of any substance abuse or dependence in the past 6 months
- History or evidence of any clinically significant medical or neurological disease, such as autoimmune disease, cancer, epilepsy, etc.
- Mental retardation or pervasive developmental disorders
- Past history of allergy to Esomeprazole
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 |
|---|---|---|
| esomeprazoleAlso: Nexiumesomeprazole 40mg /tab oral Day1-Day14 then 40mg/2 tab oral Day15-Day56 | Drug | esomeprazole |
Primary outcome
Plasma Concentration analysis
Time frame: It will be assessed on Day 1 predose, Day 14 90 mins post dose, and Day 56 90 mins post dose
The pharmacokinetic parameters for esomeprazole and its main metabolites
1 secondary outcome
CYP2C19 genotypes analysis
Time frame: The genotype will be assessed on Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2018.
- Individual participant dataSharing planned: No
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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.
Chih-Min Liu principal investigator
Visiting Staff
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing esomeprazole in people with Schizophrenia, run by National Taiwan University Hospital at 2 sites in Taiwan.
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 8 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: finished, as of the sponsor's last update on 29 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Taiwan. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Plasma Concentration analysis (time frame: It will be assessed on Day 1 predose, Day 14 90 mins post dose, and Day 56 90 mins post dose). 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 29 Mar 2018.