Pharmacokinetics and Safety Studies of Esomeprazole Use in Schizophrenia Patients

NCT03333603 | Completed Phase 4 DMC

• 1 other identifier: 201601070MIND
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Schizophrenia

Keywords

Schizophrenia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• CYP2C19 genotypes analysis

  The genotype will be assessed on Day 1

Study Arms (1)

esomeprazole

EXPERIMENTAL

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

Drug: esomeprazole

Interventions

esomeprazole DRUG

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

Also known as: Nexium

esomeprazole

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old
• Diagnosed as DSM-IV schizophrenia
• No adjustment of dose of major antipsychotics for at least 4 weeks
• Competence for inform consent

You may not qualify if:

• 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

Sponsors & Collaborators

• National Taiwan University Hospital: lead
• National Taiwan University: collaborator

Study Sites (2)

National Taiwan University Hospital

Taipei, 10048, Taiwan

Location

National Taiwan University Hospital Yunlin Branch

Taipei, Taiwan

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

Esomeprazole

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Omeprazole; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Chih-Min Liu

  Visiting Staff

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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 esomeprazoleon Day 1, Day 14 and Day 56 and the genotype of CYP2C19. The GI symptoms and related drug side effects will be evaluated.

Study Record Dates

• First Submitted: January 17, 2017
• First Posted: November 7, 2017
• Study Start: May 23, 2016
• Primary Completion: January 23, 2017
• Study Completion: January 23, 2017
• Last Updated: March 29, 2018

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

TW (2)