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

NCT00861003 | Unknown

• 1 other identifier: KSH001
• Study Type: observational
• Target: 57
• Locations: 1 country
• Sites: 1

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

Keywords

schizophrenia; adherence

Outcome Measures

Primary Outcomes (1)

• Adherence is assessed by four methods including Medication Event Monitoring System

  8 weeks

Secondary Outcomes (1)

• Various factors that have been identified as influencing adherence

  8 weeks

Study Arms (1)

Schizophrenia, antipsychotics

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

Device: Medication Event Monitoring System (MEMS)

Interventions

Medication Event Monitoring System (MEMS) DEVICE

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

Schizophrenia, antipsychotics

Eligibility Criteria

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

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Korea University Guro Hospital: lead

Study Sites (1)

Korea University Guro Hospital

Seoul, 152-703, South Korea

Location

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 12, 2009
• First Posted: March 13, 2009
• Study Start: April 1, 2009
• Primary Completion: December 1, 2009
• Study Completion: August 1, 2010
• Last Updated: March 13, 2009

Record last verified: 2009-03

Locations

KR (1)