SchizophreniaMEMS-SPRNCT00861003
An Adherence Study of Antipsychotic Medication in Outpatients With Schizophrenia or Schizoaffective Disorder
An observational study of Schizophrenia and Schizoaffective Disorder, run by Korea University Guro Hospital at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Schizophrenia, Schizoaffective Disorder
- What is being tested?
- Medication Event Monitoring System (MEMS)
- Type of treatment
- Pill or oral medicine, Medical device
- How many people
- 57 participants
- Where
- 1 siteSouth Korea
- Study dates
- Apr 2009to Aug 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Korea University Guro Hospital
Seoul, 152-703
Seung-Hyun Kim, M.D., Ph..D, 02-2626-3162, psyche731@hanmail.net
Seung-Hyun Kim, M.D., Ph.D.
About this study
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
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
- Being tested
- Medication Event Monitoring System (MEMS)
- Keywords
- schizophrenia, adherence
- Medical subject headings
- Schizophrenia, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medication Event Monitoring System (MEMS)Device
MEMS is a medication vial cap that electronically records the date and time of bottle opening.
| Study group | Role | What they receive |
|---|---|---|
| Schizophrenia, antipsychotics | Stable outpatient status of schizophrenia or schizoaffective disorder currently taking a single oral antipsychotic Receives: Device: Medication Event Monitoring System (MEMS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence is assessed by four methods including Medication Event Monitoring System
Measured: 8 weeks
Secondary outcomes (1)
Various factors that have been identified as influencing adherence
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2009 (estimated)
- Study startApr 2009
- Primary completionDec 2009 (estimated)
- Study completionAug 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 57 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Korea University Guro Hospital
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00861003
- Sponsor's protocol ID
- KSH001
- Acronym
- MEMS-SPR
- Status last verified
- Mar 2009
- First submitted
- 12 Mar 2009
- Last updated
- 13 Mar 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00861003
- Acronym / sponsor ID
- MEMS-SPR / KSH001
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Keywords
- schizophrenia, adherence
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 57 participants (estimated)
- Lead sponsor
- Korea University Guro HospitalUniversity, hospital or other
- Study start
- Apr 2009
- Primary completion
- Dec 2009 (estimated)
- Study completion
- Aug 2010 (estimated)
- First posted
- 13 Mar 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Schizophrenia, antipsychotics | – | Device: Medication Event Monitoring System (MEMS)Stable outpatient status of schizophrenia or schizoaffective disorder currently taking a single oral antipsychotic |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medication Event Monitoring System (MEMS)MEMS is a medication vial cap that electronically records the date and time of bottle opening. | Device | Schizophrenia, antipsychotics |
Primary outcome
Adherence is assessed by four methods including Medication Event Monitoring System
Time frame: 8 weeks
1 secondary outcome
Various factors that have been identified as influencing adherence
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Schizophrenia and Schizoaffective Disorder, run by Korea University Guro Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Mar 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence is assessed by four methods including Medication Event Monitoring System (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2009.