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Completed

NCT Number: NCT03333603

Pharmacokinetics and Safety Studies of Esomeprazole Use in Schizophrenia Patients

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

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Key information

Conditions

Schizophrenia Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

National Taiwan University Hospital, Taipei, Taiwan

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Esomeprazole

Drug

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

Other names: Nexium

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Collaborators

  • National Taiwan University

Registry information

Official study title

Pharmacokinetics and Safety Studies of Esomeprazole Use in Schizophrenic Patients

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Nov 7, 2017
Registry last updated
Mar 29, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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