Pharmacokinetics and Safety Studies of Esomeprazole Use in Schizophrenia Patients

Study Overview
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Brief Summary
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To evaluate the pharmacokinetic and safety for the esomeprazole use for schizophrenia

Detailed Description
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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.

Official Title
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Pharmacokinetics and Safety Studies of Esomeprazole Use in Schizophrenic Patients

Conditions
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Schizophrenia

Intervention / Treatment
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* Drug: esomeprazole


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: esomeprazole<br>esomeprazole 40mg /tab oral Day1-Day14 then 40mg/2 tab oral Day15-Day56 | Drug: esomeprazole<br>* esomeprazole 40mg /tab oral Day1-Day14 then 40mg/2 tab oral Day15-Day56<br>* Other names: Nexium;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma Concentration analysis | The pharmacokinetic parameters for esomeprazole and its main metabolites | It will be assessed on Day 1 predose, Day 14 90 mins post dose, and Day 56 90 mins post dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | The genotype will be assessed on Day 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Schizophrenia