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NCT01152697 · ClinicalTrials.gov registry record · NA
Customized Adherence Enhancement Plus Long-acting Injectable Antipsychotic
A NA study, sponsored by University Hospitals Cleveland Medical Center.
- Completed
- Registry status
- NA
- Development phase
- 30
- Enrollment target
NCT01152697 is a NA study that has completed, run by University Hospitals Cleveland Medical Center. The registered enrollment target is 30 participants.
The verdict
NCT01152697, a NA study, has completed, sponsored by University Hospitals Cleveland Medical Center.
- COMPLETED
- Registry status
- NA
- Development phase
- 30 participants
- Enrollment target
Study Summary
Psychotropic medications are a cornerstone of treatment for individuals with schizophrenia and schizoaffective disorder, however rates of full or partial non-adherence can exceed 60%. Inadequate adherence is associated with poor outcomes such as relapse, homelessness, hospitalization, and increased health care costs. Studies have shown a direct correlation between non-adherence and rates of relapse in schizophrenia; on average, non-adherent patients have a risk of relapse that is 3.7 times greater than their adherent counterparts. A major obstacle to good outcomes in the maintenance treatment of patients with severe mental illness is difficulty with medication routines on an on-going basis. For this reason, long-acting injectable antipsychotic medication is a particularly attractive treatment option for populations with schizophrenia and schizoaffective disorder, although it is unlikely that medication treatment alone is likely to modify long-term attitudes and behaviors. This prospective study is a pilot analysis of a combined approach which merges a psychosocial intervention to optimize treatment attitudes towards psychotropic medication (CAE) and long-acting injectable antipsychotic medication (L) in recently homeless individuals with schizophrenia or schizoaffective disorder who are known to have on-going difficulties with treatment non-adherence. It is expected that this combined approach (CAE-L) will improve illness outcomes among the most vulnerable of populations with schizophrenia or schizoaffective disorder.
Interventions
- DRUG haloperidol decanoate
- DRUG haloperidol
- BEHAVIORAL Customized Adherence Enhancement
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2010-06 |
| Est. Completion | 2012-08 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01152697
The ClinicalTrials.gov registry entry for NCT01152697 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University Hospitals Cleveland Medical Center, which has 230 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which haloperidol decanoate is the first listed.
NCT01152697 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01152697 about?
NCT01152697 is a clinical study titled "Customized Adherence Enhancement Plus Long-acting Injectable Antipsychotic". Psychotropic medications are a cornerstone of treatment for individuals with schizophrenia and schizoaffective disorder, however rates of full or partial non-adherence can exceed 60%. Inadequate adherence is associated with poor outcomes such as relapse, homelessness, hospitalization, and increased ...
What is the current status of trial NCT01152697?
This trial is currently completed. It is a NA study. The enrollment target is 30 participants. The study started on 2010-06. Estimated completion is 2012-08.
What interventions are being tested in trial NCT01152697?
The interventions under investigation include: haloperidol decanoate (DRUG), haloperidol (DRUG), Customized Adherence Enhancement (BEHAVIORAL).
Who is sponsoring clinical trial NCT01152697?
This trial is sponsored by University Hospitals Cleveland Medical Center, which has 230 total clinical trials registered on ClinicalTrials.gov.
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