NCT00495118

Brief Summary

The purpose of this study is to document the long-term safety of 25, 37.5, or 50 mg long-acting injectable risperidone given via injection to the gluteal muscle every 2 weeks to subjects with schizophrenia or schizoaffective disorder.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
314

participants targeted

Target at P50-P75 for phase_3 schizophrenia

Timeline
Completed

Started Oct 2001

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

October 1, 2001

Completed
3.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2005

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

June 29, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 2, 2007

Completed
Last Updated

May 17, 2011

Status Verified

May 1, 2010

First QC Date

June 29, 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, 37.5 and 50 mg long-acting injectable risperidone from baseline until study end point.

Secondary Outcomes (1)

  • To document long-term efficacy by measuring mean values and clinical improvement in Positive and Negative Symptoms Scale (Visits 3 & 5 to 10), and Clinical Global Impression scale (Visits 2 to 10), compared with previous and extension baseline.

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-62 or RIS-INT-85) or schizoaffective disorder (patients from RIS-INT-62 only) according to the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV) criteria
  • patient completed the risperidone microspheres arm of RIS-INT-62, or completed RIS-INT-85, or dropped out of the risperidone microspheres arm of RIS-INT-62 due to treatment with 75 mg long-acting injectable risperidone
  • informed consent signed by the patient
  • patient is otherwise healthy on the basis of a prestudy physical examination and medical history.

You may not qualify if:

  • A DSM-IV Axis I diagnosis other than schizophrenia or schizoaffective disorder
  • no pregnant or breast-feeding women
  • no female patient of childbearing potential without adequate contraception
  • no history of severe drug allergy or hypersensitivity
  • no subjects 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
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 29, 2007

First Posted

July 2, 2007

Study Start

October 1, 2001

Study Completion

March 1, 2005

Last Updated

May 17, 2011

Record last verified: 2010-05