UnknownNot Applicable

Evaluation of Efficacy and Safety of Long-acting Risperidone Microspheres in Patients With Schizophrenia or Other Psychotic Disorders When Switching From Typical Antipsychotic (Oral/Depot) or Atypical Oral Other Than Risperidone

China30 participantsStarted 2004-10

Plain-language summary

The purpose of this study is to evaluate the efficacy, tolerability and safety of patients on long-acting Risperidone microshpheres injection. The major advantage of long-acting injection over oral medication is facilitation of compliance in medication taking. Non-compliance is very common among schizophrenic and is a frequent cause of relapse.

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: * Subjects with schizophrenia or another psychotic disorder according to DSM IV criteria who requires long term antipsychotic therapy * Currently treated with either an atypical antipsychotic, other than risperidone, a conventional depot antipsychotic or oral conventional antipsychotic * Subject has been symptomatically stable on a stable dose of an antipsychotic the last month * Subject and/or patient's relative, guardian or legal representative has signed the informed consent form Exclusion Criteria: * First antipsychotic treatment ever * On clozapine during the last 3 month * Serious unstable medical condition * History or current symptoms of tardive dyskinesia * History of neuroleptic malignant syndrome * Pregnant or breast-feeding female * Female patient of childbearing potential without adequate contraception. * Participation in an investigational drug trial in the 30 days prior to selection * Known intolerance/non-responder to risperidone

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

Efficacy/ Clinical Global Impression

Timeframe: Week 0, 4, 8,12

Personal and Social Performance Scale

Timeframe: Week 0, 12

Extrapyramidal Symptom

Timeframe: Week 0, 4, 8,12

Trial details

NCT IDNCT00563017

SponsorHospital Authority, Hong Kong

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Contact for this trial

Wing King Lee, Dr

(852) 2388 8559 drwklee@gmail.com

View on ClinicalTrials.gov More Schizophrenia, Catatonic trials