Schizophrenia
Conditions
Keywords
Schizophrenia
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.
Interventions
DRUGesomeprazole
esomeprazole 40mg /tab oral Day1-Day14 then 40mg/2 tab oral Day15-Day56
Sponsors
National Taiwan University
National Taiwan University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. 20-65 years old 2. Diagnosed as DSM-IV schizophrenia 3. No adjustment of dose of major antipsychotics for at least 4 weeks 4. Competence for inform consent
Exclusion criteria
1. Diagnosed with schizoaffective disorder or bipolar affective disorder or organic psychotic disorder 2. Meet the diagnostic criteria of any substance abuse or dependence in the past 6 months 3. History or evidence of any clinically significant medical or neurological disease, such as autoimmune disease, cancer, epilepsy, etc. 4. Mental retardation or pervasive developmental disorders 5. Past history of allergy to Esomeprazole 6. patient who is taking clozapine、 Depakin or Diazepam 7. Pregnant 8. The patient is under the order of involuntary admission
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Plasma Concentration analysis | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| CYP2C19 genotypes analysis | The genotype will be assessed on Day 1 | Investigators will genotype CYP2C19 genotype to determine that which metabolized type (poor metabolizer, intermediate metabolizer, and good metabolizer) of patients belong to. |
Countries
Taiwan
Outcome results
None listed