Schizophrenia
Conditions
Keywords
Schizophrenia, Mental disorder, DSM-IV, RISPERDAL CONSTA, Risperidone, Long-acting risperidone, Disorganized, Catatonic, Paranoid
Brief summary
The purpose of this study is to examine treatment practices of adult schizophrenia patients by their own doctors, and to assess patient outcomes when treated with long-acting risperidone injection over a two-year period of observation.
Detailed description
This is a 2-year, prospective (a study in which the patients are identified and then followed forward in time for the outcome of the study), multi-center (at multiple sites), longitudinal (study that involves repeated observations of the same outcomes in the same people over long periods of time), observational study (study in which the investigators/ physicians observe the patients and measure their outcomes) in adults with schizophrenia (mental disorder characterized by a breakdown of thought processes and by poor emotional responsiveness). Physicians will determine the appropriate treatment for their patients, according to their usual practice. Patients starting treatment with long-acting risperidone injection (an antipsychotic medication) and meeting all the study criteria will be enrolled in the study. They will receive a dose of 25, 37.5 or 50 mg of risperidone every 2 weeks by intramuscular injection, and continue their treatment for schizophrenia according to usual care by their physicians. Patients will be asked questions at baseline and every three months for a period of two years to assess: efficacy of the medication, how well the patient is functioning, use of healthcare resources (eg, emergency room visits and hospitalizations) patient work status, quality of life and patient satisfaction with the medicine. Safety will be monitored throughout the study duration of 2 years.
Interventions
DRUGrisperidone (RISPERDAL CONSTA)
Long-acting injectable of risperidone given as per the prescription from the prescribing physician.
Sponsors
Janssen, LP
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients had schizophrenia (disorganized, catatonic, paranoid, residual, or undifferentiated) that met disease diagnostic criteria as defined in Diagnostic and Statistical Manual of Mental Disorders IV (\[DSM-IV\] * Requiring new treatment with long-acting risperidone injectable * Patients were cooperative, reliable, and able to complete all aspects of the protocol
Exclusion criteria
* Use of an investigational drug in the past 30 days * At risk to self or others
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline to 24 months in Strauss-Carpenter Levels of Function (LOF) scores | Baseline to 24 months | The Strauss-Carpenter LOF is completed by the physician. It consists of 9 items that can be grouped into 4 subscales: symptoms (absence of symptoms and recent hospitalizations), social contacts (frequency and quality of social contacts), work (quantity and quality of useful work), and function (ability to meet basic needs, fullness of life, and overall level of function). Each item is rated on a scale of 0 (worst functioning) to 4 (best functioning). |
| Clinical Global Impression of Change (CGI-C) scores during 24 months | 24 months | The CGI-C is a 7-point scale ranging from 1 to 7 (very much improved to very much worse), which is used to rate the change in the patient's illness compared to baseline. The scale assesses the patient's improvement over time. The scale is completed by physician. |
| Change from baseline to 24 months in Global Assessment of Function (GAF) scores | Baseline to 24 months | GAF is completed by the physician. GAF is a single item rating of the patient's psychological, social, and occupational functioning on a hypothetical continuum of mental health-illness. Respondents are asked to rate the subject's lowest level of functioning in the last week. GAF scores range from 0 to 100. (0 = Inadequate information, 1 = Persistent danger of severely hurting self or others and 100 = Superior functioning in a wide range of activities). |
| Change from baseline to 24 months in Personal and Social Performance (PSP) scores | Baseline to 24 months | The PSP Scale is completed by the physician. PSP is a rating of a patient's level of functioning during the past month in 4 areas: (a) socially useful activities (including work and study); (b) personal and social relationships; (c) self-care; and (d) disturbing and aggressive behaviors. Scores range from 1 to 100. (1= Lack of autonomy in basic functioning and 100 = Excellent functioning in all 4 main areas). |
| Change from baseline to 24 months in Clinical Global Impression of Severity (CGI-S) scores | Baseline (Month 0) to 24 months | The CGI-S is a 7-point scale ranging from 1 to 7 (normal, not at all ill to among the most severely ill patients), which measures disease severity in psychiatric patients. The scale is completed by physician. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline to 24 months in patient satisfaction with antipsychotic medication | Baseline to 24 months | Patients are asked a single question to evaluate patient satisfaction with their current Anti psychotic medication. The question is, The way I feel about my current antipsychotic is: and used a 7-point response scale from 1 to 7 (extremely dissatisfied to extremely satisfy). |
| Change from baseline to 24 months in healthcare resource utilization | Baseline to 24 months | Healthcare resource utilization including dates of hospitalizations (inpatient), emergency room (ER) visits, and outpatient visits, consultations with specialists and general practitioners. Relapse rates (from psychiatric hospitalizations, suicidal behavior or homicidal behavior) are also captured as resource utilization. |
| Change from baseline to 24 months in Quality of Life Assessment: Medical Outcomes Survey Short Form (SF-36) scores | Baseline to 24 months | Patients completed the SF-36. The survey includes 36 items and evaluates health status in the past 4 weeks, in 8 different areas, which can be broadly summarized as physical health (physical functioning \[PF\], role-physical \[RP\], bodily pain \[BP\] and general health \[GH\]) and mental health (vitality \[VT\], social functioning \[SF\], role-emotional \[RE\], and mental health \[MH\]). In addition, the SF-36 evaluates health status in 2 broadly-defined areas, mental health and physical health. Higher scores represent better health status. |
Countries
United States
Outcome results
None listed