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TerminatedNCT00314613Updated Dec 2, 2017

Functional Brain Imaging and Employment in First-Episode Psychotic Patients Treated With Risperdal

A Phase 4 interventional study of Antipsychotic/Risperidone Consta in Schizophrenia, sponsored by Duke University. Terminated at 2 sites in United States. Open to participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2017-12-02.

Sponsored by Duke University · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
30
Allocation
Non-randomized
Ages
18 Years to 40 Years
Sex
All
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Study summary

Assured treatment with Risperal CONSTA will provide first-episode patients, who have a greater potential for therapeutic response, with their best opportunity for continued improvement in cognitive function beyond three months of treatment.

Read the detailed description

First episode patients have a greater potential for therapeutic response than multi-episode patients, and many of them also havea great desire to rejoin the workforce. Unfortunately, first episode patients become non-compliant or intermittently compliant with prescribed antipsychotic treatment at least as frequently as multi-episode patients. We believe that assured treatment with Risperal CONTSTA will provide first episode patients wiwth their best opporutnity for continued improvement in cognitive function beyond 3 months of treatment and that improvements in cognitive function will be associated with a greater likelihood of employment, real-world outcomes, such as independent living, as well as measures of brain function.

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Conditions studied

  • Schizophrenia

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Keywords

  • Schizophreniform; Schizophrenia; Schizoaffective Disorders
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In context

Schizophrenia

3,470 studies on the registry are indexed under Schizophrenia; 471 are open to participants now.

This study's planned enrollment of 30 is below the median of 70 across 2,871 interventional studies indexed under Schizophrenia.

Browse Schizophrenia studies →

Lead sponsor

Duke University is the lead sponsor of 2,025 studies on the registry; 275 are open to participants now.

Of its 194 completed or terminated interventional studies of FDA-regulated products, 159 (82%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • male or female between 18-40 years of age
  • meet DSM-IV criteria for first-episode schizophreniform, schizophrenia or schizoaffective disorder

Exclusion criteria

Exclusion Criteria:

  • pregnant \& breast-feeding women
  • patients with known sensitivity to oral Risperdal
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Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Non-randomized
Masking
None (open label)
Enrollment
30 participants (estimated)

Interventions

  • DrugAntipsychotic/Risperidone Consta
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Study locations

2 sites
  • John Umstead Hospital
    Butner, North Carolina 27509, United States
  • Duke University Medical Center
    Durham, North Carolina 27710, United States
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 2, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00314613
Lead sponsor
Duke University
Collaborators
Janssen, LP
First posted
Apr 14, 2006
Start date
Apr 2006
Primary completion
Dec 2006
Last update
Dec 2, 2017

Study contacts

William H Wilson, PhD
principal investigator · Duke University
Joseph P McEvoy, MD
principal investigator · Duke University
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in May 2010. You cannot join it, but the record below documents what was studied.

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