SchizophreniaNCT00223522
Do Self-Report and Physician Impressions of Adherence to Oral Antipsychotic Medication Agree With Objective Data?
An observational study of Schizophrenia and Schizoaffective, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
Trial summary
The purpose of this study is to prospectively examine adherence to oral atypical antipsychotics in patients with schizophrenia. We are psrticularly interested in examining the level of agreement among self-report, physician impressions and objective measures of adherence. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Schizophrenia, Schizoaffective
- What is being tested?
- MEMS caps
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2004to Mar 2005
- 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 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosis of Schizophrenia or Schizoaffective disorder
- Between the ages of 18-55
- no documented history of head injury, mental retardation or neurological disorder
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to prospectively examine adherence to oral atypical antipsychotics in patients with schizophrenia. We are psrticularly interested in examining the level of agreement among self-report, physician impressions and objective measures of adherence. We believe that physicians, casemanagers, and clients significantly overestimate the level of adherence.
Read the detailed description
Fifty schizophrenia patients will be recruited at the time of their clinic visit to Tri-County MHMR Services and the El Paso Community MHMR Center. Both physicians and patients will be asked to rate the patient's medication adherence on their index clinic visit. Initial ratings will also occur at this visit. After filling their medication prescription, all subjects will be given electronic medication caps that record each time and date their medication container is opened. Patients will then be followed in the community for the next 12 weeks to observe actual adherence to medication from the index visit to the next successive clinic visit. Every two weeks pills will be counted and data will be retrieved from the electronic medication caps. During the first and last two weeks of study, blood will be sampled on two randomly selected occasions approximately 72 hours apart. Self-report and physician assessment of adherence, symptom and attitudinal measures will be obtained a second time at the second clinic visit 12 weeks after the index visit.
- Conditions
- Schizophrenia, Schizoaffective
- Being tested
- MEMS caps
- Keywords
- Schizophrenia, Schizoaffective, MEMS, adherence to antipsychotic medication
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MEMS capsDevice
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startApr 2004
- Study completionMar 2005
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.
- More trials run by The University of Texas Health Science Center at San AntonioThe sponsor's other registered studies.
- 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
- Time perspective
- Prospective
- Enrolment
- 50 participants
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Janssen Pharmaceutica N.V., Belgium
- Investigators
- Dawn I Velligan, Ph.D., Principal investigator, University of Texas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00223522
- Sponsor's protocol ID
- 034-0013-002
- Other IDs
- 034-0013-002
- Status last verified
- Sep 2005
- First submitted
- 14 Sep 2005
- Last updated
- 22 Sep 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Do Self-Report and Physician Impressions of Adherence to Oral Antipsychotic Medication Agree With Objective Data?
- ClinicalTrials.gov ID
- NCT00223522
- Acronym / sponsor ID
- 034-0013-002
- Conditions
- Schizophrenia, Schizoaffective
- Keywords
- Schizophrenia, Schizoaffective, MEMS, adherence to antipsychotic medication
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Collaborators
- Janssen Pharmaceutica N.V., Belgium
- Study start
- Apr 2004
- Study completion
- Mar 2005
- First posted
- 22 Sep 2005 (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.
The purpose of this study is to prospectively examine adherence to oral atypical antipsychotics in patients with schizophrenia. We are psrticularly interested in examining the level of agreement among self-report, physician impressions and objective measures of adherence. We believe that physicians, casemanagers, and clients significantly overestimate the level of adherence.
Detailed description
Fifty schizophrenia patients will be recruited at the time of their clinic visit to Tri-County MHMR Services and the El Paso Community MHMR Center. Both physicians and patients will be asked to rate the patient's medication adherence on their index clinic visit. Initial ratings will also occur at this visit. After filling their medication prescription, all subjects will be given electronic medication caps that record each time and date their medication container is opened. Patients will then be followed in the community for the next 12 weeks to observe actual adherence to medication from the index visit to the next successive clinic visit. Every two weeks pills will be counted and data will be retrieved from the electronic medication caps. During the first and last two weeks of study, blood will be sampled on two randomly selected occasions approximately 72 hours apart. Self-report and physician assessment of adherence, symptom and attitudinal measures will be obtained a second time at the second clinic visit 12 weeks after the index visit.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Diagnosis of Schizophrenia or Schizoaffective disorder
- Between the ages of 18-55
- no documented history of head injury, mental retardation or neurological disorder
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| MEMS caps | Device | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2005.
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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.
Dawn I Velligan, Ph.D. principal investigator
University of Texas
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, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
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 3 inclusion and 0 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: finished, as of the sponsor's last update on 22 Sep 2005. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
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 22 Sep 2005.