Status:
UNKNOWN
An Adherence Study of Antipsychotic Medication in Outpatients With Schizophrenia or Schizoaffective Disorder
Lead Sponsor:
Korea University Guro Hospital
Conditions:
Schizophrenia
Schizoaffective Disorder
Eligibility:
All Genders
20-65 years
Brief Summary
This prospective study examines the differences among several measures of adherence to antipsychotic medications in outpatients with schizophrenia. Adherence is assessed by using self-report, physicia...
Eligibility Criteria
Inclusion
- Ability to provide written informed consent
- Male or female, aged from 20 to 65 years
- Clinician rendered diagnosis of schizophrenia or schizoaffective disorder documented by a checklist of Diagnostic and Statistical Manual of Mental Disorders- Fourth Edition (DSM-IV) criteria
- Currently taking a single oral antipsychotic (e.g., Quetiapine, Risperidone, Olanzapine, or Amisulpride).
- Female patients of childbearing potential must be using a reliable method of contraception and have a negative urine human chorionic gonadotropine (HCG) test at enrolment
- Outpatient status, with psychiatric hospitalization or psychiatric emergency room visit within the previous 2 years and no hospitalizations within 3 months
- mild to moderate symptom checked by CGI-S (less than score 4)
- Able to understand and comply with the requirements of the study
Exclusion
- Any DSM-IV Axis I disorder not defined in the inclusion criteria
- Presence of a co-morbid diagnosis that might influence outcome measures (e.g., mental retardation)
- Alcohol or substance dependence at enrolment (except dependence in full remission, and except for caffeine or nicotine dependence), as defined by DSM-IV criteria
- Patients who, in the opinion of the investigator, pose an imminent risk of suicide or a danger to self or others
- Pregnancy or lactation
- Evidence of hypersensitivity to Quetiapine or other antipsychotics used in the study
- Use of any cytochrome P450 inhibitors or inducers in the 14 days preceding enrolment
- Administration of a depot antipsychotic injection within one dosing interval (for the depot) before randomisation
- use of pillbox
- Treatment with Clozapine (because of its unique monitoring guidelines)
- Administration of electroconvulsive therapy (ECT) in the last 6 months
- Unstable or inadequately treated medical condition such as heart, liver, kidney, or lung disease, or a seizure disorder
- Involvement in the planning and conduct of the other study.
- Participation in another drug trial within 4 weeks prior enrolment into this study or longer in accordance with local requirements.
Key Trial Info
Start Date :
April 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 1 2010
Estimated Enrollment :
57 Patients enrolled
Trial Details
Trial ID
NCT00861003
Start Date
April 1 2009
End Date
August 1 2010
Last Update
March 13 2009
Active Locations (1)
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1
Korea University Guro Hospital
Seoul, South Korea, 152-703