An Adherence Study of Antipsychotic Medication in Outpatients With Schizophrenia or Schizoaffective Disorder (MEMS-SPR)
Recruitment status was Not yet recruiting
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Schizophrenia Schizoaffective Disorder |
Device: Medication Event Monitoring System (MEMS) |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
| 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 |
- Adherence is assessed by four methods including Medication Event Monitoring System [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
- Various factors that have been identified as influencing adherence [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 57 |
| Study Start Date: | April 2009 |
| Estimated Study Completion Date: | August 2010 |
| Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Schizophrenia, antipsychotics
Stable outpatient status of schizophrenia or schizoaffective disorder currently taking a single oral antipsychotic
|
Device: Medication Event Monitoring System (MEMS)
MEMS is a medication vial cap that electronically records the date and time of bottle opening.
|
Eligibility| Ages Eligible for Study: | 20 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
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
Inclusion Criteria:
- 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 Criteria:
- 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.
Contacts and Locations| Korea, Republic of | |
| Korea University Guro Hospital | Not yet recruiting |
| Seoul, Korea, Republic of, 152-703 | |
| Contact: Seung-Hyun Kim, M.D., Ph..D 02-2626-3162 psyche731@hanmail.net | |
| Principal Investigator: Seung-Hyun Kim, M.D., Ph.D. | |
| Sub-Investigator: Jaewon Yang, M.D., Ph.D. | |
More Information
No publications provided
| Responsible Party: | Seung-Hyun Kim, Professor |
| ClinicalTrials.gov Identifier: | NCT00861003 History of Changes |
| Other Study ID Numbers: | KSH001 |
| Study First Received: | March 12, 2009 |
| Last Updated: | March 12, 2009 |
| Health Authority: | Korea: Food and Drug Administration |
Keywords provided by Korea University Guro Hospital:
|
schizophrenia adherence |
Additional relevant MeSH terms:
|
Psychotic Disorders Schizophrenia Schizophrenia and Disorders with Psychotic Features Mental Disorders Antipsychotic Agents Tranquilizing Agents |
Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Psychotropic Drugs |
ClinicalTrials.gov processed this record on May 23, 2013