Patient and physician preferences and satisfaction with oral and long-acting injectable long-term antipsychotic treatment for psychotic disorders

• Conditions: Schizophrenia, schizoaffective disorder, delusional disorder, psychotic disorder NOS or any other psychotic disorder patients demanding long term antipsychotic treatment; MedDRA version: 9.1Level: LLTClassification code 10037253Term: Psychotic disorder NOS; MedDRA version: 9.1Level: LLTClassification code 10061920Term: Psychotic disorder; MedDRA version: 9.1Level: HLGTClassification code 10039628Term: Schizophrenia and other psychotic disorders; MedDRA version: 9.1Level: HLTClassification code 10012256Term: Delusional disorders; MedDRA version: 9.1Level: LLTClassification code 10039621Term: Schizoaffective disorder

• Registration Number: EUCTR2009-011343-39-FI
• Lead Sponsor: Janssen-Cilag AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-04-15
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 780

Inclusion Criteria

1. Written informed consent obtained from patient;
2. Male or female adult patient >= 18 years old;
3. Patient diagnosed with schizophrenia, schizoaffective disorder, delusional disorder, psychotic disorder NOS or any other psychotic disorder demanding long term antipsychotic treatment;
4. The patient’s psychotic symptoms has, according to clinical judgment, been stable during the past three months without a need for major interventions due to clinical deterioration (like hospitalization and/or major changes in medication);
5. Patients current main antipsychotic therapy is:
a. Atypical oral antipsychotic; or
b. Atypical long acting injectable (LAI) antipsychotic; or
c. Conventional LAI antipsychotic.
6. Patient should have been treated with their current main antipsychotic therapy for a minimum of 6 months and a maximum of 24 months.
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Patient experiencing an acute relapse/exacerbation of schizophrenia symptoms;
2. Patient registered on involuntary/compulsory therapy (LPT and forensic patients);
3. Patient currently participating in a randomized controlled trial.

Study & Design

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