NCT00314613

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for phase_4 schizophrenia

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2006

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

April 12, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 14, 2006

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2006

Completed
Last Updated

December 2, 2017

Status Verified

May 1, 2010

Enrollment Period

8 months

First QC Date

April 12, 2006

Last Update Submit

November 29, 2017

Conditions

Schizophrenia

Keywords

Schizophreniform; Schizophrenia; Schizoaffective Disorders

Interventions

Antipsychotic/Risperidone ConstaDRUG

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

John Umstead Hospital

Butner, North Carolina, 27509, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

SchizophreniaPsychotic Disorders

Interventions

Antipsychotic Agents

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Tranquilizing AgentsCentral Nervous System DepressantsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and UsesCentral Nervous System AgentsTherapeutic UsesPsychotropic Drugs

Study Officials

  • William H Wilson, PhD

    Duke University

    PRINCIPAL INVESTIGATOR

  • Joseph P McEvoy, MD

    Duke University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 12, 2006

First Posted

April 14, 2006

Study Start

April 1, 2006

Primary Completion

December 1, 2006

Last Updated

December 2, 2017

Record last verified: 2010-05

Locations

US(2)