Pharmacokinetics and Safety Studies of Esomeprazole Use in Schizophrenia Patients

Schizophrenia Clinical Trial

Official title:

Pharmacokinetics and Safety Studies of Esomeprazole Use in Schizophrenic Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03333603
• Other study ID #: 201601070MIND
• Status: Completed
• Phase: Phase 4
• First received: January 17, 2017
• Last updated: March 26, 2018
• Start date: May 23, 2016
• Est. completion date: January 23, 2017

Study information

• Verified date: January 2017
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To evaluate the pharmacokinetic and safety for the esomeprazole use for schizophrenia

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: January 23, 2017
• Est. primary completion date: January 23, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Schizophrenia

Intervention

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

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei
Taiwan	National Taiwan University Hospital Yunlin Branch	Taipei

Sponsors (2)

Lead Sponsor	Collaborator
National Taiwan University Hospital	National Taiwan University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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