An Adherence Study of Antipsychotic Medication in Outpatients With Schizophrenia or Schizoaffective Disorder (MEMS-SPR)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2009 by Korea University Guro Hospital.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Korea University Guro Hospital
ClinicalTrials.gov Identifier:
NCT00861003
First received: March 12, 2009
Last updated: NA
Last verified: March 2009
History: No changes posted
  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

Resource links provided by NLM:


Further study details as provided by Korea University Guro Hospital:

Primary Outcome Measures:
  • Adherence is assessed by four methods including Medication Event Monitoring System [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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
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

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

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00861003

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.            
Sponsors and Collaborators
Korea University Guro Hospital
  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