A European study with long-acting antipsychotics for schizophrenic patients

Phase 1

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

• Registration Number: EUCTR2014-002765-30-CZ
• Lead Sponsor: EGRIS

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-04-08
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• 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 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

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 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 clinical trial of medicinal product
• Study Design: Not specified