NCT00236587

Brief Summary

The purpose of this study is to document the long term safety of a long-acting injectable formulation of risperidone in the treatment of patients with schizophrenia who have previously been treated with long-acting risperidone. Efficacy will also be evaluated.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P25-P50 for phase_3 schizophrenia

Timeline
Completed

Started Nov 2001

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

November 1, 2001

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2004

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

October 7, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 12, 2005

Completed
Last Updated

June 8, 2011

Status Verified

January 1, 2011

First QC Date

October 7, 2005

Last Update Submit

June 6, 2011

Conditions

Schizophrenia

Keywords

SchizophreniaIntramuscular injectionAntipsychotic agentsLong-acting risperidone

Outcome Measures

Primary Outcomes (1)

  • To accumulate long-term safety data: incidence of adverse events and clinical evaluations (physical examination, Extrapyramidal Symptom Rating Scale [ESRS], laboratory tests, ECGs).

Secondary Outcomes (1)

  • To evaluate long-term efficacy: Positive and Negative Syndrome Scale for Schizophrenia and the Clinical Global Impression-Severity of Illness subscale (CGI-S) every 3 months, including last visit.

Interventions

risperidoneDRUG

Eligibility Criteria

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

You may qualify if:

  • Completion of RIS-USA-256 within 7 days

You may not qualify if:

  • History of neuroleptic malignant syndrome, a rare psychotropic-drug reaction, which may be characterized by confusion, reduced consciousness, high fever or pronounced muscle stiffness
  • Significant and untreated or unstable medical illness such as diabetes, hypertension, angina
  • Serious illness of the liver, kidney, or significant disturbances of the cardiac, pulmonary, gastrointestinal, endocrine, neurological system
  • Pregnant or nursing females, or those lacking adequate contraception
  • Known hypersensitivity or unresponsiveness to risperidone

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Schizophrenia

Interventions

Risperidone

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial

    Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

    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

October 7, 2005

First Posted

October 12, 2005

Study Start

November 1, 2001

Study Completion

February 1, 2004

Last Updated

June 8, 2011

Record last verified: 2011-01