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Pharmacokinetics and Safety Studies of Esomeprazole Use in Schizophrenia Patients

Pharmacokinetics and Safety Studies of Esomeprazole Use in Schizophrenic Patients

NCT03333603•National Taiwan University Hospital

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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.

Eligibility

Age

20 - 65 years

Sex

ALL

Healthy Volunteers

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

Locations (2)

National Taiwan University Hospital

Taipei, Taiwan

National Taiwan University Hospital Yunlin Branch

Taipei, Taiwan

Key Dates

Start Date

May 23, 2016

Primary Completion Date

January 23, 2017

Completion Date

January 23, 2017

Last Updated

March 29, 2018

Enrollment

ACTUAL participants

Conditions

Schizophrenia

Interventions

esomeprazole

DRUG

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Psychotic DisordersSchizophrenia Spectrum Disorders

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RECRUITING

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 29, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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Pharmacokinetics and Safety Studies of Esomeprazole Use in Schizophrenia Patients

Inclusion Criteria

Exclusion Criteria

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