Pharmacokinetics and Safety Studies of Esomeprazole Use in Schizophrenia Patients

NCT ID: NCT03333603

Last Updated: 2018-03-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-05-23
• Study Completion Date: 2017-01-23

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.

Conditions

Schizophrenia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

esomeprazole

esomeprazole 40mg /tab oral Day1-Day14 then 40mg/2 tab oral Day15-Day56

Group Type: EXPERIMENTAL

esomeprazole

Intervention Type: DRUG

esomeprazole 40mg /tab oral Day1-Day14 then 40mg/2 tab oral Day15-Day56

Interventions

esomeprazole

esomeprazole 40mg /tab oral Day1-Day14 then 40mg/2 tab oral Day15-Day56

Intervention Type: DRUG

Other Intervention Names

Nexium

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Taiwan University

OTHER

Sponsor Role: collaborator

National Taiwan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Chih-Min Liu

Role: PRINCIPAL_INVESTIGATOR

Visiting Staff

Locations

National Taiwan University Hospital

Taipei, , Taiwan

National Taiwan University Hospital Yunlin Branch

Taipei, , Taiwan

Countries

Taiwan

Other Identifiers

201601070MIND

Identifier Type: -

Identifier Source: org_study_id