CompletedPhase 4

A Switch Study of BMS-337039 in Schizophrenic Out-patients

Austria, Belgium, Czechia450 participantsStarted 2005-06-01

Plain-language summary

The purpose of this clinical research study is to evaluate the safety and tolerability of two switching strategies from risperidone to aripiprazole over a period of 12 weeks in out-patients who are treated in a general psychiatric practice setting and who are currently experiencing efficacy and/or safety/tolerability issues while on risperidone.

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: * Patients with a diagnosis of schizophrenia as defined by DSM-IV-TR2 criteria * Out-patients who have been taking Risperidone for minimum 6 weeks who are not optimally controlled and/or experiencing safety/tolerability issues with Risperidone * Men and women, aged 18 - 65 years Exclusion Criteria: * Patients who are at risk for committing suicide * Patients with a diagnosis of schizoaffective disorder, bipolar disorder, depression with psychotic symptoms, or organic brain syndromes * Meeting DSM-IV-TR criteria for any significant Psychoactive Substance Use Disorder within the 3 months prior to Screening * Treatment-resistant to antipsychotic medication

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

Proportion of patients who discontinue because of Adverse Events

Timeframe: Up to 22 months

Trial details

NCT IDNCT00232687

SponsorOtsuka Pharmaceutical Development & Commercialization, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2007-04-01

View on ClinicalTrials.gov More Schizophrenia trials