Schizophrenia Clinical Trial
— HOSPIPalmOfficial title:
HOSPItal Use of Paliperidone Palmitate - A Prospective Non-Interventional Study
The purpose of this study to evaluate safety, tolerability, treatment outcomes, appropriate use and pattern of paliperidone palmitate usage in participants with schizophrenia in the hospital setting.
Status | Completed |
Enrollment | 371 |
Est. completion date | August 2014 |
Est. primary completion date | August 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Participants diagnosed with schizophrenia - Participant admitted to hospital due to an exacerbation of their schizophrenia prior to any study-related activity - Participant may, in the opinion of the participating physician, benefit from treatment with paliperidone palmitate which will be initiated within 3 weeks after admission to hospital Exclusion Criteria: - Participant has a known hypersensitivity to paliperidone or risperidone - Participant has previously been treated with paliperidone palmitate - Participant has a history of neuroleptic malignant syndrome - Participant was on clozapine or has previously been treated with any long-acting injectable antipsychotic during the last 3 months |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Janssen-Cilag International NV |
Belgium, Bulgaria, Denmark, Germany, Greece, Israel, Kazakhstan, Russian Federation,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of participants with adverse events | Up to 6 weeks | Yes | |
Primary | Number of participants who discontinue the study due to adverse events | Up to 6 weeks | Yes | |
Secondary | Change from baseline in Extrapyramidal Symptom Rating Scale (ESRS) score | The ESRS is a 12 item clinician-rated scale designed to assess the severety of extrapyramidal symptoms. Dyskinesic movements are rated according to bothfrequency and amplitude. It measures the four types of drug-induced movement disorders. (Parkinsonism, Dystonia, akathisia, and Dyskinesia). Items are rated on a 7-point scale ranging from 0 (normal) to 6 (extremely severe). The higher the score, the more severely the symptoms affect function. Higher scores indicate worsening. | Baseline, Week 1, Week 2, Week 5, and Week 6 | Yes |
Secondary | Change from baseline in total Brief Psychiatric Rating Scale (BPRS) score | The BPRS is used for the measurement of psychiatric symptoms. The BPRS is an 18 item questionnaire and each question is rated on a 7 point scale ranging from 1 (not present) to 7 (extremely severe). The total score for the 18 question will be calculated by adding score of each question. The interpretation of the total scores are: 0-9 will indicate "not a schizoaffective case"; 10-20 will indicate "possible schizoaffective case"; and 21 or more, will indicate "evident schizoaffective case". Higher scores indicate worsening. | Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, and Week 6 | No |
Secondary | Clinical Global Impression - Severity (CGI-S) scale score | The CGI-S rating scale is a 7-point global assessment that measures the clinician's impression of the severity of illness exhibited by a participant. A rating of 1 is equivalent to "Normal, not at all ill" and a rating of 7 is equivalent to "Among the most extremely ill participants". Higher scores indicate worsening. | Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, and Week 6 | No |
Secondary | Clinical Global Impression - Change (CGI-C) scale score | The CGI-C is a 7-point assessment scale of change in global clinical status, defined as a sense of well-being and ability to function in daily activities. CGI-C scores range from 1 (very much improved) through to 7 (very much worse). Higher scores indicate worsening. | Week 6 | No |
Secondary | Change from baseline in Personal and Psychosocial functioning (PSP) scale score | The PSP is used as a measure of personal and social functioning of participants with psychiatric disorders. The PSP scale assesses the degree of difficulty a participant exhibits over a 1-month period within 4 domains of behavior: socially useful activities, personal and social relationships, self-care, and disturbing and aggressive behavior and provide rating from 1 to 100. Participants with score of 71 to 100 have a mild degree of difficulty; from 31 to 70 have marked difficulty and from 1 to 30, have represent severe degrees of difficulty. Lower scores indicate worsening. | Baseline and Week 6 | No |
Secondary | Subject Satisfaction with previous antipsychotic medication (MSQ) scale score | Treatment satisfaction with previous anti psychiatric medication among participants with schizophrenia will be assessed by using the MSQ scale. It consists of 1 question: "Overall, how satisfied are you with your current antipsychotic medication(s)?" with responses assessed on a 7-point scale rated as follows: 1=extremely dissatisfied, 2=very dissatisfied, 3=somewhat dissatisfied, 4=neither satisfied nor dissatisfied, 5=somewhat satisfied, 6=very satisfied, and 7=extremely satisfied. Lower scores indicate worsening. | Baseline | No |
Secondary | Subject Satisfaction with study medication (paliperidone palmitate) scale score | Treatment satisfaction with study medication (paliperidone palmitate) among participants with schizophrenia will be assessed by using the MSQ scale. It consists of 1 question: "Overall, how satisfied are you with your current antipsychotic medication(s)?" with responses assessed on a 7-point scale rated as follows: 1=extremely dissatisfied, 2=very dissatisfied, 3=somewhat dissatisfied, 4=neither satisfied nor dissatisfied, 5=somewhat satisfied, 6=very satisfied, and 7=extremely satisfied. Lower scores indicate worsening. | Week 6 | No |
Secondary | Change from baseline in body weight | Baseline and Week 6 | Yes |
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