A European study with long-acting antipsychotics for schizophrenic patients

Phase 1

• Conditions: Schizophrenia ICD-10 code F20; MedDRA version: 19.0Level: PTClassification code 10039626Term: SchizophreniaSystem Organ Class: 10037175 - Psychiatric disorders; Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

• Registration Number: EUCTR2014-002765-30-DE
• Lead Sponsor: niversity Medical Center Utrecht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-03-03
• Last Update Posted: 9 January 2017

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 600

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 six 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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 600
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Intolerance / hypersensitivity to one of the drugs (including active substances, metabolites and excipients) in this study including oral risperidone, paliperidone and aripiprazole.
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 non-response and/or intolerance to any of the study medications.
6.Forensic patients.
7.Patients who have been treated with an investigational drug within 30 days prior to screening.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified