NCT00236457

Brief Summary

The purpose of this study is to document both short-term, as well as long-term efficacy and safety of a long-acting injectable formulation of risperidone, in comparison with olanzapine for the treatment of 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
629

participants targeted

Target at P75+ for phase_3 schizophrenia

Timeline
Completed

Started Nov 2000

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, 2000

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2002

Completed
2.9 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

November 1, 2010

First QC Date

October 7, 2005

Last Update Submit

June 6, 2011

Conditions

SchizophreniaPsychotic Disorders

Keywords

SchizophreniaIntramuscular injectionAntipsychotic agentsLong-acting risperidoneOlanzapine

Outcome Measures

Primary Outcomes (1)

  • Mean change from baseline to Week 13 for total score using the Structured Clinical Interview- Positive and Negative Syndrome Scale (SCI-PANSS)

Secondary Outcomes (1)

  • Change from baseline through each visit and at study end (Week 53) for SCI-PANSS total score, SCI-PANSS subscales, Clinical Global Impression (CGI) and Wisconsin Quality of Life Index (W-QOLI). Safety evaluations throughout the study.

Interventions

risperidoneDRUG

Eligibility Criteria

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

You may qualify if:

  • Diagnosis of schizophrenia or schizoaffective disorder according to criteria of Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DMS IV)
  • Positive and Negative Syndrome Scale (PANSS) total score =\>50, indicating at least a minimum level of mental and behavioral disorders
  • Recent hospitalization or an episode of psychosis requiring medical intervention
  • Body Mass Index (BMI) \<=40 (BMI \>=30 indicates obesity)

You may not qualify if:

  • Diagnosis of DMS IV Axis I condition other than schizophrenia or schizoaffective disorder
  • History of neuroleptic malignant syndrome, a rare psychotropic-drug reaction, which may be characterized by confusion, reduced consciousness, high fever or pronounced muscle stiffness
  • Past treatment with clozapine
  • Pregnant or nursing females, or those lacking adequate contraception
  • Known sensitivity or unresponsiveness to risperidone or olanzapine
  • Treatment with a long-acting injectable antipsychotic drug near the time of the trial start

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

  • 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
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 7, 2005

First Posted

October 12, 2005

Study Start

November 1, 2000

Study Completion

December 1, 2002

Last Updated

June 8, 2011

Record last verified: 2010-11