European Long-acting Antipsychotics in Schizofrenia Trial EULAST

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 15

Inclusion Criteria

1. Diagnosis of schizophrenia as defined by DSM-IV-R as determined by the M.I.N.I.plus;2. Age 18 or older. ;3. The first psychosis occurred at least 6 months and no more than 7 years ago.;4. If patients are using an antipsychotic drug, a medication switch is currently under consideration.;5. Capable of providing written informed consent

Exclusion Criteria

1. Intolerance / hypersensitivity to both* of the drugs (including active substances, metabolites and excipients) in this study including oral paliperidone and aripiprazole and/or hypersensitivity to risperidone.
2. Pregnancy or lactation.
3. Patients who are currently using clozapine.
4. Patients who do not fully comprehend the purpose or are not competent to make a rational decision whether or not to participate.
5. Patients with a documented history of intolerance to both* of the study medications and/or a documented history of non-response to a treatment with both* study drugs of at least 6 weeks within the registered dose range.
6. Forensic patients.
7. Patients who have been treated with an investigational drug within 30 days prior to screening.
8. Simultaneous participation in another intervention study (neither medication nor psychosocial intervention).
* If intolerance/hypersensitivity or non-response in the past to one of the compounds is documented, the patient can still participate; however, randomization will take place by blocking that specific compound.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary outcome is all cause discontinuation (i.e. discontinuation or switching<br /><br>of medication, adding a second antipsychotic agent beyond the allowed limit,<br /><br>patient withdraws consent, patient has missed a monthly visit despite a<br /><br>reminder). </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary outcome measures includes scores on the Positive and Negative Symptom<br /><br>Scale (PANSS), CGI, Personal and Social Performance scale (PSP), Subjective<br /><br>Wellbeing (SWN), quality of life (EQ-5D), cognitive functioning, prevalence of<br /><br>aggression incidents, resource utilization and safety measures. In a separate<br /><br>protocol with a separate consent form, patients will be asked to provide blood<br /><br>for genetic and immune system analyses.</p><br>