NCT00511628

Brief Summary

The purpose of this study is to evaluate the safety of risperidone treatment in patients who are overweight and/or obese.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
1,717

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2001

Status
terminated

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

July 1, 2001

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2003

Completed
4.6 years until next milestone

First Submitted

Initial submission to the registry

August 2, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 6, 2007

Completed
Last Updated

May 19, 2011

Status Verified

March 1, 2011

First QC Date

August 2, 2007

Last Update Submit

May 18, 2011

Conditions

SchizophreniaSchizoaffective DisorderSchizophreniform Disorder

Keywords

SchizophreniaRisperidoneSchizoaffective disorderSchizophreniform disorderWeight gain

Outcome Measures

Primary Outcomes (1)

  • Safety Evaluation of Risperidone in patients who are overweight and/or obese

    6 months

Secondary Outcomes (1)

  • Effectiveness

    6 months

Study Arms (1)

001

Risperidone As prescribed

Drug: Risperidone

Interventions

RisperidoneDRUG

As prescribed

001

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with Schizophrenia or Schizoaffective disorder, in which physicians considered the use of risperidone as treatment under clinical practice with a BMI \>25; Patients have increased their body weight \>7% in the last year with the previous treatment even with a BMI\< 25 ; Patients that have shown intolerance to a previous antipsychotic treatment

You may qualify if:

  • Patients with Schizophrenia or Schizoaffective disorder, in which physicians considered the use of risperidone as treatment under clinical practice with a BMI \>25
  • Patients have increased their body weight \>7% in the last year with the previous treatment even with a BMI\< 25
  • Patients that have shown intolerance to a previous antipsychotic treatment

You may not qualify if:

  • Pregnant or lactating patients
  • Patients with psychiatry pathology other than Schizophrenia or schizoaffective disorder
  • Patients with neurology pathology except Parkinsonism induced by neuroleptics
  • Patients with other severe concomitant pathology
  • Patients treated with Risperidone in the last 30 days.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

SchizophreniaPsychotic DisordersWeight Gain

Interventions

Risperidone

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersBody Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Janssen-Cilag S.A. (formerly Janssen Sp) Clinical Trial

    Janssen-Cilag, S.A.

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 2, 2007

First Posted

August 6, 2007

Study Start

July 1, 2001

Study Completion

January 1, 2003

Last Updated

May 19, 2011

Record last verified: 2011-03