CompletedPhase 4

Long-acting Injectable Risperidone in Patients With Schizophrenia After an Acute Episode

Denmark, Finland, France220 participantsStarted 2005-11

Plain-language summary

The primary objective of this randomized trial was to investigate whether early initiation of treatment with Risperdal Consta after an acute episode was not inferior to the routine approach (oral treatment for 12 weeks followed by treatment with Risperdal Consta). .

Who can participate

Age range

18 Years – 65 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: * Diagnosis of schizophrenia by criteria of Diagnostic and Statistical Manual of Mental Diseases, Fourth Edition (DSM-IV) * acute episode of schizophrenia within 2 weeks of study entry * o subjects currently not treated or treated with oral antipsychotics or short-acting injectable antipsychotics (zuclopenthixol acutard is allowed) at doses not exceeding the registered dose * Positive And Negative Syndrome Scale (PANSS) score \>=80 * Clinical Global Impression - Severity (CGI-S) score \>=5 Exclusion Criteria: * DSM-IV axis I diagnosis other than schizophrenia * known hypersensitivity or lack of response to risperidone * pregnant or nursing females, or those without adequate contraception * alcohol or drug abuse or dependence diagnosed in the last month prior to entry,

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 in Positive And Negative Syndrome Scale (PANSS) Total Score From Baseline to Endpoint

Timeframe: at baseline and Week 26 or at premature discontinuation

Trial details

NCT IDNCT00216671

SponsorJanssen Pharmaceutica N.V., Belgium

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2009-12

Results submitted2011-01-07

View on ClinicalTrials.gov More Schizophrenia trials

Who can participate

Age range

18 Years – 65 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.