CompletedNot Applicable

Observational Study in Patients With Schizophrenia Treated With Long-Acting Risperidone Injection (RISPERDAL CONSTA)

United States532 participantsStarted 2004-09

Plain-language summary

The purpose of this study is to examine treatment practices of adult schizophrenia patients by their own doctors, and to assess patient outcomes when treated with long-acting risperidone injection over a two-year period of observation.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients had schizophrenia (disorganized, catatonic, paranoid, residual, or undifferentiated) that met disease diagnostic criteria as defined in Diagnostic and Statistical Manual of Mental Disorders IV (\[DSM-IV\] * Requiring new treatment with long-acting risperidone injectable * Patients were cooperative, reliable, and able to complete all aspects of the protocol Exclusion Criteria: * Use of an investigational drug in the past 30 days * At risk to self or others

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change from baseline to 24 months in Clinical Global Impression of Severity (CGI-S) scores

Timeframe: Baseline (Month 0) to 24 months

Clinical Global Impression of Change (CGI-C) scores during 24 months

Timeframe: 24 months

Change from baseline to 24 months in Global Assessment of Function (GAF) scores

Timeframe: Baseline to 24 months

Change from baseline to 24 months in Personal and Social Performance (PSP) scores

Timeframe: Baseline to 24 months

Change from baseline to 24 months in Strauss-Carpenter Levels of Function (LOF) scores

Timeframe: Baseline to 24 months

Trial details

NCT IDNCT00246194

SponsorJanssen, LP

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2007-11

View on ClinicalTrials.gov More Schizophrenia trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change from baseline to 24 months in Clinical Global Impression of Severity (CGI-S) scores

Timeframe: Baseline (Month 0) to 24 months

Clinical Global Impression of Change (CGI-C) scores during 24 months

Timeframe: 24 months

Change from baseline to 24 months in Global Assessment of Function (GAF) scores

Timeframe: Baseline to 24 months

Change from baseline to 24 months in Personal and Social Performance (PSP) scores

Timeframe: Baseline to 24 months

Change from baseline to 24 months in Strauss-Carpenter Levels of Function (LOF) scores

Timeframe: Baseline to 24 months