Pharmacokinetics and Safety Studies of Esomeprazole Use in Schizophrenia Patients

March 26, 2018 updated by: National Taiwan University Hospital

Pharmacokinetics and Safety Studies of Esomeprazole Use in Schizophrenic Patients

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan, 10048
        • National Taiwan University Hospital
      • Taipei, Taiwan
        • National Taiwan University Hospital Yunlin Branch

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: esomeprazole
esomeprazole 40mg /tab oral Day1-Day14 then 40mg/2 tab oral Day15-Day56
Drug: esomeprazole
esomeprazole 40mg /tab oral Day1-Day14 then 40mg/2 tab oral Day15-Day56
Other Names:
  • Nexium

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Plasma Concentration analysis
Time Frame: 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
It will be assessed on Day 1 predose, Day 14 90 mins post dose, and Day 56 90 mins post dose

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CYP2C19 genotypes analysis
Time Frame: 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.
The genotype will be assessed on Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Collaborators

National Taiwan University

Investigators

  • Principal Investigator: Chih-Min Liu, visiting staff

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 23, 2016

Primary Completion (Actual)

January 23, 2017

Study Completion (Actual)

January 23, 2017

Study Registration Dates

First Submitted

January 17, 2017

First Submitted That Met QC Criteria

November 2, 2017

First Posted (Actual)

November 7, 2017

Study Record Updates

Last Update Posted (Actual)

March 29, 2018

Last Update Submitted That Met QC Criteria

March 26, 2018

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201601070MIND

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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