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NCT00215579 · ClinicalTrials.gov registry record · Phase 4
Determining the Effects of Risperdal Consta in Patients With Psychotic Disorders and Incomplete Adherence
A Phase 4 study of Schizophrenia and Schizoaffective Disorder, sponsored by Duke University.
- Completed
- Registry status
- Phase 4
- Development phase
- 64
- Enrollment target
- 1
- Study location
NCT00215579 is a Phase 4 study of Schizophrenia and Schizoaffective Disorder that has completed, run by Duke University. The registered enrollment target is 64 participants, below the 219-participant average among 315 other Schizophrenia trials with a reported enrollment target (71% lower). The trial reports 1 study location across 1 state.
The verdict
NCT00215579, a Phase 4 study of Schizophrenia and Schizoaffective Disorder, has completed, sponsored by Duke University.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 64 participants
- Enrollment target
- 1
- Study location
Study Summary
As many as 75 percent of patients with schizophrenia have difficulty taking their oral medication on a regular basis. This may lead to worsening of symptoms. Clinicians commonly respond to these problems by adding adjunctive medications, despite the absence of systematic studies that support such practices. It is possible, however, that in many of these cases, the unstable course and/or unsatisfactory treatment response reflects incomplete adherence with the originally prescribed oral antipsychotic, rather than a need for adjunctive medications. This study will examine whether switching patients who demonstrate an unstable course and/or an unsatisfactory clinical response to a long-acting injectable preparation as the primary antipsychotic may enhance medication adherence and improve outcomes.
Conditions Studied
Interventions
- DRUG Depot Risperidone Microsphere (Consta)
Study Locations (1)
North Carolina
- John Umstead Hospital - Butner
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 64 participants |
| Start Date | 2004-04 |
| Est. Completion | 2006-04 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00215579
The ClinicalTrials.gov registry entry for NCT00215579 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 64 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 219-participant average among 315 other Schizophrenia trials with a reported enrollment target (71% lower). The listed sponsor is Duke University, which has 1,725 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Schizophrenia appearing as the primary indexed condition, and to 1 intervention - of which Depot Risperidone Microsphere (Consta) is the first listed.
NCT00215579 reports 1 study location spanning 1 distinct geographic area - top geographies include North Carolina.
Frequently Asked Questions
What is clinical trial NCT00215579 about?
NCT00215579 is a clinical study titled "Determining the Effects of Risperdal Consta in Patients With Psychotic Disorders and Incomplete Adherence". As many as 75 percent of patients with schizophrenia have difficulty taking their oral medication on a regular basis. This may lead to worsening of symptoms. Clinicians commonly respond to these problems by adding adjunctive medications, despite the absence of systematic studies that support such pr...
What is the current status of trial NCT00215579?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 64 participants. The study started on 2004-04. Estimated completion is 2006-04.
What conditions does trial NCT00215579 study?
This clinical trial studies the following conditions: Schizophrenia, Schizoaffective Disorder.
What interventions are being tested in trial NCT00215579?
The interventions under investigation include: Depot Risperidone Microsphere (Consta) (DRUG).
Who is sponsoring clinical trial NCT00215579?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00215579 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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