NCT00240708

Brief Summary

The purpose of this study is to evaluate the effectiveness and safety of risperidone, formulated as a long-acting injectable drug, compared with risperidone tablets in the treatment of patients with schizophrenia.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
205

participants targeted

Target at P25-P50 for phase_3 schizophrenia

Timeline
Completed

Started Jun 2004

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

June 1, 2004

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

October 14, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 18, 2005

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2006

Completed
Last Updated

May 17, 2011

Status Verified

March 1, 2010

First QC Date

October 14, 2005

Last Update Submit

May 16, 2011

Conditions

Schizophrenia

Keywords

Schizophreniaintramuscular injectionantipsychotic agentsrisperidonelong-acting injectable

Outcome Measures

Primary Outcomes (1)

  • Positive and Negative Syndrome Scale (PANSS) at screening, Weeks 8, 16, and 24.

Secondary Outcomes (1)

  • Clinical Global Impression-Changes (CGI-C), from baseline at Weeks 8, 16 and 24; Brief Psychiatric Rating Scale (BPRS) at baseline and biweekly from Weeks 4 through 18; Clinical Global Impressions-severity (CGI-S)

Interventions

risperidoneDRUG

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of schizophrenia by the criteria of Diagnostic and Statistical Manual of Mental Diseases, 4th Edition (DSM-IV )
  • treatment with an antipsychotic drug (up to 6 milligrams/day of risperidone or equivalent dose) for 28 days before study initiation with no change in the dosage
  • Total Positive and Negative Syndrome Scale (PANSS) score \>=60 and \<120 at start of study.

You may not qualify if:

  • Diagnosis of mental disease other than schizophrenia
  • treated with a sustained-release injection of other antipsychotic medications within 60 days before the initiation of the study
  • history of cerebrovascular accident, convulsive disorder such as epilepsy, diabetes mellitus, liver disease, kidney disease, cardiovascular disorder, malignancy or physical exhaustion due to dehydration or malnutrition
  • have risk factors of diabetes mellitus, such as hyperglycemia.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Ostuzzi G, Bighelli I, So R, Furukawa TA, Barbui C. Does formulation matter? A systematic review and meta-analysis of oral versus long-acting antipsychotic studies. Schizophr Res. 2017 May;183:10-21. doi: 10.1016/j.schres.2016.11.010. Epub 2016 Nov 17.

    PMID: 27866695DERIVED

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

  • Janssen Pharmaceutical K.K. Clinical Trial

    Janssen Pharmaceutical K.K.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 14, 2005

First Posted

October 18, 2005

Study Start

June 1, 2004

Study Completion

April 1, 2006

Last Updated

May 17, 2011

Record last verified: 2010-03