NCT00088075

Brief Summary

A clinical study to evaluate the efficacy, safety and tolerability of two dose ranges of risperidone (1 to 3 mg/day, and 4 to 6 mg/day) versus placebo (an inactive substance like a sugar pill) in adolescents (aged 13 to 17 years) with schizophrenia (i.e. abnormal behavior and thoughts). The study duration is about 6 to 7 weeks.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
160

participants targeted

Target at P25-P50 for phase_3 schizophrenia

Timeline
Completed

Started Aug 2004

Shorter than P25 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

First Submitted

Initial submission to the registry

July 19, 2004

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 21, 2004

Completed
11 days until next milestone

Study Start

First participant enrolled

August 1, 2004

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2005

Completed
Last Updated

June 8, 2011

Status Verified

January 1, 2011

First QC Date

July 19, 2004

Last Update Submit

June 6, 2011

Conditions

Schizophrenia

Keywords

SchizophreniaRisperidoneAdolescents

Outcome Measures

Primary Outcomes (1)

  • Change in total PANSS (Positive and Negative Syndrome Scale for Schizophrenia) from baseline to the 6-week endpoint

Secondary Outcomes (1)

  • Change from baseline in PANSS subscale scores and Clinical Global Impression (CGI-S and CGI-I) scores, number of subjects achieving a clinical response (at least 20% improvement in total PANSS), safety and tolerability.

Interventions

RisperidoneDRUG

Eligibility Criteria

Age13 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • A responsible person must be available to accompany the subject to the site at each visit
  • patient must meet the DSM-IV criteria for schizophrenia

You may not qualify if:

  • Patients with mild, moderate or severe mental retardation
  • patients with a known or suspected history of substance dependence
  • subjects weighing \<35kg
  • subjects who cannot swallow oral tablets

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Haas M, Unis AS, Armenteros J, Copenhaver MD, Quiroz JA, Kushner SF. A 6-week, randomized, double-blind, placebo-controlled study of the efficacy and safety of risperidone in adolescents with schizophrenia. J Child Adolesc Psychopharmacol. 2009 Dec;19(6):611-21. doi: 10.1089/cap.2008.0144.

    PMID: 20035579RESULT

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
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 19, 2004

First Posted

July 21, 2004

Study Start

August 1, 2004

Study Completion

December 1, 2005

Last Updated

June 8, 2011

Record last verified: 2011-01