Status:
COMPLETED
Pharmacokinetics and Safety Studies of Esomeprazole Use in Schizophrenia Patients
Lead Sponsor:
National Taiwan University Hospital
Collaborating Sponsors:
National Taiwan University
Conditions:
Schizophrenia
Eligibility:
All Genders
20-65 years
Phase:
PHASE4
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 u...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
May 23 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 23 2017
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT03333603
Start Date
May 23 2016
End Date
January 23 2017
Last Update
March 29 2018
Active Locations (2)
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1
National Taiwan University Hospital
Taipei, Taiwan, 10048
2
National Taiwan University Hospital Yunlin Branch
Taipei, Taiwan