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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: Completed Phase 4 study of Schizophrenia and Schizoaffective Disorder, sponsored by Duke University.

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. According to ClinicalTrials.gov, the official US trial registry.

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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.

Interventions

  • DRUG Depot Risperidone Microsphere (Consta)

Study Locations (1)

North Carolina

  • John Umstead Hospital - Butner

Trial Details

FieldValue
Enrollment Target 64 participants
Start Date 2004-04
Est. Completion 2006-04
Phase Phase 4
Duke University

1,725 total trials

What the finished NCT00215579 record still lists

NCT00215579 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 64 participants, a relatively small participant target, below the 219-participant average among 315 other Schizophrenia trials with a reported enrollment target (71% lower).

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 a single indexed study location in 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.

Similar trials for Schizophrenia

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT00215579's enrollment target sits among peer trials

64 185th of 315 higher than 131 of 315 other Schizophrenia trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Schizophrenia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00215579, the US trial registry maintained by the National Library of Medicine. NCT00215579 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.