Pharmacokinetics and Safety Studies of Esomeprazole Use in Schizophrenia Patients
Status and phase
Conditions
Treatments
Details and patient eligibility
About
To evaluate the pharmacokinetic and safety for the esomeprazole use for schizophrenia
Full 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.
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion 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
Trial design
Primary purpose
Allocation
Interventional model
Masking
25 participants in 1 patient group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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