European Long-acting Antipsychotics in Schizophrenia Trial
- Conditions
- F20Schizophrenia
- Registration Number
- DRKS00007568
- Lead Sponsor
- Foundation European Group for Research in Schizophrenia (EGRIS)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 523
Diagnosis of schizophrenia as defined by DSM-IV-R( Diagnostic and Statistical Manual) as determined by the M.I.N.I.plus
Age 18 or older.
The first psychosis occurred at least six months and no more than 7 years ago.
If patients are using an antipsychotic drug, a medication switch is currently under consideration.
Capable of providing written informed consent
Intolerance / hypersensitivity to one of the drugs (including active substances, metabolites and excipients) in this study including oral risperidone, paliperidone and aripiprazole.
Pregnancy or lactation.
Patients who are currently using clozapine.
Patients who do not fully comprehend the purpose or are not competent to make a rational decision whether or not to participate.
Patients with a documented history of non-response and/or intolerance to any of the study medications.
Forensic patients.
Patients who have been treated with an investigational drug within 30 days prior to screening.
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method All cause discontinuation rates [ Time Frame: 18 months ] [ Designated as safety issue: No ]<br><br>Compare all cause discontinuation rates in patients with schizophrenia randomized to oral antipsychotic medications (i.e., aripiprazole or paliperidone) versus depot antipsychotic medications (i.e., paliperidone palmitate or aripiprazole depot).<br><br>Discontinuation consist of (multiple options are possible):<br><br> the allocated treatment is stopped or used at doses outside the allowed range.<br> medication is switched or augmented with another antipsychotic after visit 4 for more than 1 month continuously or for more than 3 months cumulative over the 18 months of the trial.<br> a patient misses a monthly visit and does not show up after reminding him<br> patient withdraws consent for the study.<br> clinician decision to withdraw the patient.<br>
- Secondary Outcome Measures
Name Time Method