Back to resultsPharmacokinetics and Safety Studies of Esomeprazole Use in Schizophrenia Patients
Primary Purpose
Schizophrenia
Status
Completed
Phase
Phase 4
Locations
Taiwan
Study Type
Interventional
Intervention
esomeprazole
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia focused on measuring Schizophrenia
Eligibility Criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
Sites / Locations
- National Taiwan University Hospital
- National Taiwan University Hospital Yunlin Branch
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
esomeprazole
Arm Description
esomeprazole 40mg /tab oral Day1-Day14 then 40mg/2 tab oral Day15-Day56
Outcomes
Primary Outcome Measures
Plasma Concentration analysis
The pharmacokinetic parameters for esomeprazole and its main metabolites
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT03333603
First Posted
January 17, 2017
Last Updated
March 26, 2018
Sponsor
National Taiwan University Hospital
Collaborators
National Taiwan University
1. Study Identification
Unique Protocol Identification Number
NCT03333603
Brief Title
Pharmacokinetics and Safety Studies of Esomeprazole Use in Schizophrenia Patients
Official Title
Pharmacokinetics and Safety Studies of Esomeprazole Use in Schizophrenic Patients
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
May 23, 2016 (Actual)
Primary Completion Date
January 23, 2017 (Actual)
Study Completion Date
January 23, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital
Collaborators
National Taiwan University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Schizophrenia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
esomeprazole
Arm Type
Experimental
Arm Description
esomeprazole 40mg /tab oral Day1-Day14 then 40mg/2 tab oral Day15-Day56
Intervention Type
Drug
Intervention Name(s)
esomeprazole
Other Intervention Name(s)
Nexium
Intervention Description
esomeprazole 40mg /tab oral Day1-Day14 then 40mg/2 tab oral Day15-Day56
Primary Outcome Measure Information:
Title
Plasma Concentration analysis
Description
The pharmacokinetic parameters for esomeprazole and its main metabolites
Time Frame
It will be assessed on Day 1 predose, Day 14 90 mins post dose, and Day 56 90 mins post dose
Secondary Outcome Measure Information:
Title
CYP2C19 genotypes analysis
Description
Investigators will genotype CYP2C19 genotype to determine that which metabolized type (poor metabolizer, intermediate metabolizer, and good metabolizer) of patients belong to.
Time Frame
The genotype will be assessed on Day 1
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria
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
Exclusion criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chih-Min Liu
Organizational Affiliation
Visiting Staff
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
10048
Country
Taiwan
Facility Name
National Taiwan University Hospital Yunlin Branch
City
Taipei
Country
Taiwan
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Pharmacokinetics and Safety Studies of Esomeprazole Use in Schizophrenia Patients
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