An Adherence Study of Antipsychotic Medication in Outpatients With Schizophrenia or Schizoaffective Disorder

Schizophrenia Clinical Trial

— MEMS-SPR  

Official title:

An Exploratory Study on Comparison of Electronic Monitoring and Other Measures of Adherence to Antipsychotic Medication in Outpatients With Schizophrenia or Schizoaffective Disorder

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00861003
• Other study ID #: KSH001
• Status: Not yet recruiting
• Phase: N/A
• First received: March 12, 2009
• Last updated: March 12, 2009
• Start date: April 2009
• Est. completion date: August 2010

Study information

• Verified date: March 2009
• Source: Korea University Guro Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Observational

Clinical Trial 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, physician report, pill count and electronic monitoring. The rates of adherence/non-adherence with various tools will be manifested. The association between antipsychotic adherence/non-adherence and various clinical status, including psychotic symptoms, depressive symptoms, side effects, neurocognitive function and insight are analyzed. Participants are assessed at baseline during a visit to their outpatient clinic and followed up for 8 weeks.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 57
• Est. completion date: August 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Ability to provide written informed consent

2. Male or female, aged from 20 to 65 years

3. 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

4. Currently taking a single oral antipsychotic (e.g., Quetiapine, Risperidone, Olanzapine, or Amisulpride).

5. 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

6. Outpatient status, with psychiatric hospitalization or psychiatric emergency room visit within the previous 2 years and no hospitalizations within 3 months

7. mild to moderate symptom checked by CGI-S (less than score 4)

8. Able to understand and comply with the requirements of the study

Exclusion Criteria:

1. Any DSM-IV Axis I disorder not defined in the inclusion criteria

2. Presence of a co-morbid diagnosis that might influence outcome measures (e.g., mental retardation)

3. Alcohol or substance dependence at enrolment (except dependence in full remission, and except for caffeine or nicotine dependence), as defined by DSM-IV criteria

4. Patients who, in the opinion of the investigator, pose an imminent risk of suicide or a danger to self or others

5. Pregnancy or lactation

6. Evidence of hypersensitivity to Quetiapine or other antipsychotics used in the study

7. Use of any cytochrome P450 inhibitors or inducers in the 14 days preceding enrolment

8. Administration of a depot antipsychotic injection within one dosing interval (for the depot) before randomisation

9. use of pillbox

10. Treatment with Clozapine (because of its unique monitoring guidelines)

11. Administration of electroconvulsive therapy (ECT) in the last 6 months

12. Unstable or inadequately treated medical condition such as heart, liver, kidney, or lung disease, or a seizure disorder

13. Involvement in the planning and conduct of the other study.

14. Participation in another drug trial within 4 weeks prior enrolment into this study or longer in accordance with local requirements.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Psychotic Disorders
• Schizoaffective Disorder
• Schizophrenia

Intervention

Device:
• Medication Event Monitoring System (MEMS)
MEMS is a medication vial cap that electronically records the date and time of bottle opening.

Locations

Country	Name	City	State
Korea, Republic of	Korea University Guro Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Korea University Guro Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adherence is assessed by four methods including Medication Event Monitoring System		8 weeks	No
Secondary	Various factors that have been identified as influencing adherence		8 weeks	No