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

NCT ID: NCT00861003

Last Updated: 2009-03-13

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 57 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-04-30
• Study Completion Date: 2010-08-31

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, 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.

Conditions

Schizophrenia; Schizoaffective Disorder

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Schizophrenia, antipsychotics

Stable outpatient status of schizophrenia or schizoaffective disorder currently taking a single oral antipsychotic

Medication Event Monitoring System (MEMS)

Intervention Type: DEVICE

MEMS is a medication vial cap that electronically records the date and time of bottle opening.

Interventions

Medication Event Monitoring System (MEMS)

MEMS is a medication vial cap that electronically records the date and time of bottle opening.

Intervention Type: DEVICE

Eligibility Criteria

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

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Korea University Guro Hospital

OTHER

Sponsor Role: lead

Responsible Party

Professor

Locations

Korea University Guro Hospital

Seoul, , South Korea

Countries

South Korea

Facility Contacts

Seung-Hyun Kim, M.D., Ph..D

Role: primary

psyche731@hanmail.net

02-2626-3162

Other Identifiers

KSH001

Identifier Type: -

Identifier Source: org_study_id