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

NCT ID: NCT00314613

Last Updated: 2017-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-04-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Schizophrenia

Keywords

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Schizophreniform; Schizophrenia; Schizoaffective Disorders

Study Design

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Allocation Method

NON_RANDOMIZED

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Antipsychotic/Risperidone Consta

Intervention Type DRUG

Eligibility Criteria

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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

* pregnant \& breast-feeding women
* patients with known sensitivity to oral Risperdal
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Janssen, LP

INDUSTRY

Sponsor Role collaborator

Duke University

OTHER

Sponsor Role lead

Principal Investigators

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William H Wilson, PhD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Joseph P McEvoy, MD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

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John Umstead Hospital

Butner, North Carolina, United States

Site Status

Duke University Medical Center

Durham, North Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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7858

Identifier Type: -

Identifier Source: secondary_id

RIS-NAP-4007

Identifier Type: -

Identifier Source: secondary_id

7858

Identifier Type: -

Identifier Source: org_study_id