NCT00558298

Brief Summary

The purpose of this study is to document the long-term safety of 25, 50 or 75 mg long-acting injectable risperidone given via injection to the gluteal muscle every 2 weeks to patients with schizophrenia or schizoaffective disorder.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
811

participants targeted

Target at P75+ for phase_3 schizophrenia

Timeline
Completed

Started Feb 2000

Longer than P75 for phase_3 schizophrenia

Status
completed

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

February 1, 2000

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2005

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

November 12, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 14, 2007

Completed
Last Updated

May 17, 2011

Status Verified

April 1, 2010

First QC Date

November 12, 2007

Last Update Submit

May 16, 2011

Conditions

SchizophreniaSchizoaffective Disorder

Keywords

schizophreniaschizoaffective disorderrisperidoneintramuscular injectionlong-acting injectable

Outcome Measures

Primary Outcomes (1)

  • To document the long-term safety of 25, 50 and 75 mg long-acting injectable risperidone from baseline until study endpoint.

Secondary Outcomes (1)

  • The mean values and change from baseline in Clinical Global Impression scale (CGI) at each time point until study endpoint.

Interventions

risperidoneDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of schizophrenia (patients from RIS-INT-57 or RIS-INT-61) or schizoaffective disorder (patients from RIS-INT-57 only) according to the DSM-IV criteria
  • patient completed RIS-INT-57 or RIS-INT-61 or dropped out after completion of 3 injection cycles in RIS-INT-61 (i.e., at or after Visit 4)
  • Patient was otherwise healthy on the basis of a prestudy physical examination and medical history.

You may not qualify if:

  • No DSM-IV diagnosis of substance abuse or dependence within 3 months prior to entry in RIS-INT-57 or RIS-INT-61 (excluding nicotine and caffeine dependence)
  • No pregnant or breast-feeding women
  • No female patient of childbearing potential without adequate contraception
  • No history of severe drug allergy or hypersensitivity
  • No patients known to be unresponsive to risperidone.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

SchizophreniaPsychotic Disorders

Interventions

Risperidone

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Janssen, LP Clinical Trial

    Janssen, LP

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 12, 2007

First Posted

November 14, 2007

Study Start

February 1, 2000

Study Completion

February 1, 2005

Last Updated

May 17, 2011

Record last verified: 2010-04