Ignite Creation Date:
2024-05-05 @ 4:59 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00369239
Status:
COMPLETED
Last Update Posted:
2011-05-17
First Post:
2006-08-25
Brief Title:
Treatment With Risperidone Long Acting Injectable RLAI in an Early Phase of Psychosis
Sponsor:
Janssen Pharmaceutica NV Belgium
Organization:
Janssen Pharmaceutica NV Belgium
Study Overview
Official Title:
Is Premorbid Functioning a Predictor of Outcome in Patients With Early Onset Psychosis Treated With Risperdal Consta
Status:
COMPLETED
Status Verified Date:
2010-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this research study is to see how well patients in an early phase of their illness respond to treatment and whether this depends on how well they functioned socially academically and vocationally before becoming ill The study also examines whether patients with more insight into their illness have better outcomes
Detailed Description:
Intervention with antipsychotic medications during the early stages of schizophrenia may result in a better outcome for patients with a higher number of patients achieving full remission a shorter time to remission and decreased risk of relapse In addition there is evidence to suggest that a critical window of opportunity exists in the early period of syndromal differentiation when pharmacological intervention and intensive engagement of the patient may impact favourably on symptoms in the longer term
The long-acting injectable formulation of risperidone has shown improvements in measures of disease severity over the oral formulation and demonstrated an improved safety and tolerability profile because of its lower peak-trough levels A recent study has demonstrated that patients in the early phase of their illness 0-3 years benefit from treatment with RLAI
Although premorbid functioning is accepted to be a predictor of outcome and to affect treatment adherence prospective clinical data are scarce RLAI addresses the problem of adherence by eliminating the need for daily medication intake In this study we investigate whether patients with good premorbid functioning respond better to treatment with RLAI compared to patients with poor premorbid functioning Moreover patients with schizophrenia often fail to acknowledge their illness and need for treatment - so-called lack of insight Previous studies investigating the relationship between acute psychopathology and insight have produced conflicting results Multiple administrations of a structured measure of insight SAI-E and symptom measures will provide here a means to evaluate whether insight is correlated with clinical change whether insight changes over time and whether changes in insight are related to changes in psychopathology
A physical examination will be performed including heart rate blood pressure and weight Interviews and assessments will be made to complete standard rating scales Positive and Negative Symptom Score PANSS Scale for Assessment of Insight-Expanded version SAI-E Clinical Global Impression CGI Global Assessment of Functioning GAF and Extrapyramidal Symptom Rating Scale ESRS The Short-Form-36 questionnaire SF-36 will be completed by the patient Any health problems and medicines of the patient will be recorded
The primary hypothesis that patients with Stable-good premorbid functioning will have better outcomes than those with Stable-poor premorbid functioning will be examined by dividing patients into a Stable-good and Stable-poor premorbid functioning groups based on their total scores on the Premorbid Adjustment Scale PAS Statistically significant differences between the Stable-good vs Stable-poor pre-morbid groups on the combined change measure at the 5 level will be interpreted as supporting the hypothesis
Association of insight and outcomes will be examined using Scale for Assessment of Insight-Expanded version SAI-E and insight item G 12 from Positive and Negative Symptom Score PANSS Effectiveness Clinical Global Impression CGI-SC PANSS retention rate functioning Short-Form-36 questionnaire SF-36 rehospitalisation rates and safety and tolerability will be assessed The observation period is 6 months RLAI is given as intramuscular injections every 2 weeks The starting dose of RLAI will be in accordance with the product label usually 25 mg If necessary the dosage of the injection may be increased gradually Treatment duration is 26 weeks To ensure continued antipsychotic coverage until the main release of risperidone from the microspheres previous antipsychotic therapy will be continued concomitantly during the first three weeks of the study
The long-acting injectable formulation of risperidone has shown improvements in measures of disease severity over the oral formulation and demonstrated an improved safety and tolerability profile because of its lower peak-trough levels A recent study has demonstrated that patients in the early phase of their illness 0-3 years benefit from treatment with RLAI
Although premorbid functioning is accepted to be a predictor of outcome and to affect treatment adherence prospective clinical data are scarce RLAI addresses the problem of adherence by eliminating the need for daily medication intake In this study we investigate whether patients with good premorbid functioning respond better to treatment with RLAI compared to patients with poor premorbid functioning Moreover patients with schizophrenia often fail to acknowledge their illness and need for treatment - so-called lack of insight Previous studies investigating the relationship between acute psychopathology and insight have produced conflicting results Multiple administrations of a structured measure of insight SAI-E and symptom measures will provide here a means to evaluate whether insight is correlated with clinical change whether insight changes over time and whether changes in insight are related to changes in psychopathology
A physical examination will be performed including heart rate blood pressure and weight Interviews and assessments will be made to complete standard rating scales Positive and Negative Symptom Score PANSS Scale for Assessment of Insight-Expanded version SAI-E Clinical Global Impression CGI Global Assessment of Functioning GAF and Extrapyramidal Symptom Rating Scale ESRS The Short-Form-36 questionnaire SF-36 will be completed by the patient Any health problems and medicines of the patient will be recorded
The primary hypothesis that patients with Stable-good premorbid functioning will have better outcomes than those with Stable-poor premorbid functioning will be examined by dividing patients into a Stable-good and Stable-poor premorbid functioning groups based on their total scores on the Premorbid Adjustment Scale PAS Statistically significant differences between the Stable-good vs Stable-poor pre-morbid groups on the combined change measure at the 5 level will be interpreted as supporting the hypothesis
Association of insight and outcomes will be examined using Scale for Assessment of Insight-Expanded version SAI-E and insight item G 12 from Positive and Negative Symptom Score PANSS Effectiveness Clinical Global Impression CGI-SC PANSS retention rate functioning Short-Form-36 questionnaire SF-36 rehospitalisation rates and safety and tolerability will be assessed The observation period is 6 months RLAI is given as intramuscular injections every 2 weeks The starting dose of RLAI will be in accordance with the product label usually 25 mg If necessary the dosage of the injection may be increased gradually Treatment duration is 26 weeks To ensure continued antipsychotic coverage until the main release of risperidone from the microspheres previous antipsychotic therapy will be continued concomitantly during the first three weeks of the study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None