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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2009-011343-39-FI
Enrollment
780
Registered
2009-04-15
Start date
2009-06-15
Completion date
Unknown
Last updated
2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizophrenia, schizoaffective disorder, delusional disorder, psychotic disorder NOS or any other psychotic disorder patients demanding long term antipsychotic treatment MedDRA version: 9.1 Level: LLT Classification code 10037253 Term: Psychotic disorder NOS MedDRA version: 9.1 Level: LLT Classification code 10061920 Term: Psychotic disorder MedDRA version: 9.1 Level: HLGT Classification code 10039628 Term: Schizophrenia and other psychotic disorders MedDRA version: 9.1 Level: HLT Classifica

Interventions

Pharmaceutical Form:

Sponsors

Janssen-Cilag AB
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
Main Objective: The primary objective of the study is to compare overall patient treatment satisfaction with current medication in patients with schizophrenia, schizoaffective disorder, delusional disorder, psychotic disorder NOS (not otherwise specified) or any other psychotic disorder. Three treatment groups will be included: 1) Atypical oral antipsychotics; 2) Conventional LAI antipsychotics; 3) Atypical LAI antipsychotic (Risperdal Consta®).;Secondary Objective: Patient perception of efficacy and effectiveness, functioning, adverse events and adherence with their current treatment will be investigated. Patient attitudes towards, and preferences for, administration formulation, as well as their perception of information received regarding different treatment options will also be studied. For patients on atypical oral therapy without previous experience of LAI therapy specific questions will address willingness to consider antipsychotic LAI therapy as a treatment option. Physicians’ clinical global impression of severity, assessment of adherence and patient medication satisfaction, and attitudes towards different types of antipsychotic treatment will be studied. Physicians’ reasons for prescribing, and switching between, the different treatment options will be investigated.;Primary end point(s): The primary objective of the study is to compare overall patient treatment satisfaction with current medication in patients with schizophrenia, schizoaffective disorder, delusional disorder, psychotic disorder NOS (not otherwise specified) or any other psychotic disorder. Three treatment groups will be included: 1) Atypical oral antipsychotics; 2) Conventional LAI antipsychotics; 3) Atypical LAI antipsychotic (Risperdal Consta®).

Countries

Finland

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026