- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07445217
Predictive Validity of the Personal and Social Performance Scale for PANSS Outcomes in Schizophrenia
Predictive Validity of the Personal and Social Performance Scale for PANSS Outcomes in Schizophrenia: a Severity-stratified Study
The Positive and Negative Syndrome Scale (PANSS) is a widely used instrument for assessing symptom severity in schizophrenia, whereas the Personal and Social Performance Scale (PSP) provides a practical measure of functional outcomes. This study aimed to evaluate the predictive validity of the PSP for PANSS outcomes in individuals with schizophrenia.
A total of 763 patients diagnosed with schizophrenia and receiving paliperidone treatment were recruited in a 12-week multicenter prospective study. Among participants with a baseline PANSS score greater than 90, those with a 12-week PSP score above 60 were more likely to achieve a reduction of more than 20% in PANSS scores, whereas those with a PSP score below 60 showed less improvement.
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Pingtung City, Taiwan, 925
- Calo Psychiatric Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- criteria diagnosis of schizophrenia
Exclusion Criteria:
- schizoaffective disorder
- severe major depressive disorder
- bipolar disorder
- substance use disorders
- organic brain conditions
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: The Effects of paliperidone on symptom improvement in schizophrenia
Patients diagnosed with schizophrenia and receiving paliperidone treatment were recruited in a 12-week multicenter prospective study.
Among participants with a baseline PANSS score greater than 90, those with a 12-week PSP score above 60 were more likely to achieve a reduction of more than 20% in PANSS scores, whereas those with a PSP score below 60 showed less improvement.
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Assessments were conducted at baseline, week 4, and week 12.
Two widely used scales-the PANSS and PSP-were utilized to evaluate patients before and after treatment, followed by a correlation analysis of the results.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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the gender different in the effect of paliperidone treatment in schizophrenia
Time Frame: The differences were evaluated before treatment, and week 4 and week 12 after treatment.
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The difference of paliperidone treatment between males and females were explored at baseline, week 4, and week 12.
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The differences were evaluated before treatment, and week 4 and week 12 after treatment.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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The PANSS responses in schizophrenia with paliperidone
Time Frame: The responses of PANSS were evaluated before the treatment, and week 4 and week 12 after treatment
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The Positive and Negative Syndrome Scale (PANSS) was utilized to evaluate the symptom improvment in individuals undergoing antipsychotic treatment.
PANSS scores below 58 indicatemild symptoms, higher scores indicate more severe symptoms.
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The responses of PANSS were evaluated before the treatment, and week 4 and week 12 after treatment
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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The predictive validity of the PSP for PANSS outcomes in schizophrenia
Time Frame: PSP was utilized to evaluate patients before treatment, and week 4 and week 12 after treatment.
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To explore the Personal and Social Performance Scale (PSP) as a practical and efficient tool for monitoring treatment response and functional outcomes in schizophrenia, or not.
The scores of PSP with higher scores indicate higher functional recovery.
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PSP was utilized to evaluate patients before treatment, and week 4 and week 12 after treatment.
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- References 1. Lopez-Munoz F, Alamo C, Cuenca E, Shen WW, Clervoy P, Rubio G. History of the discovery and clinical introduction of chlorpromazine. Ann Clin Psychiatry. 2005; 17: 113-135. 2. Juckel G, Morosini PL. The new approach: psychosocial functioning as a necessary outcome criterion for therapeutic success in schizophrenia. Curr Opin Psychiatry. 2008; 21: 630-639. 3. Kay SR, Fiszbein A, Opler LA. The positive and negative syndrome scale (PANSS) for schizophrenia. Schizophr Bull. 1987; 13: 261-276. 4. Kay SR, Opler LA, Lindenmayer JP. Reliability and validity of the positive and negative syndrome scale for schizophrenics. Psychiatry Res. 1988; 23: 99-110. 5. Lim K, Peh OH, Yang Z, Rekhi G, Rapisarda A, See YM, Rashid NAA, Ang MS, Lee SA, Sim K, Huang H, Lencz T, Lee J, Lam M. Large-scale evaluation of the Positive and Negative Syndrome Scale (PANSS) symptom architecture in schizophrenia. Asian J Psychiatry. 2021; 62: 102732. 6. Jelastopulu E, Giourou E, Merekoulias G, Mestousi A, Moratis E, Alexopoulos EC. Correlation between the Personal and Social Performance scale (PSP) and the Positive and Negative Sydrome Scale (PANSS) in a Greek sample of patients with schizophrenia. BMC Psychiatry. 2014; 14: 197. 7. Morosini PL, Magliano L, Brambilla L, Ugolini S, Pioli R. Development, reliability and acceptability of a new version of the DSM-IV Social and Occupational Functioning Assessment Scale (SOFAS) to assess routine social functioning. Acta Psychiatr Scand. 2000; 101: 323-329. 8. Lung FW, Shu BC, Kao WT, Chen CN, Ku YC, Tzeng DS. Association of DRD4 uVNTR and TP53 codon 72 polymorphisms with schizophrenia: a case-control study. BMC Med Genet. 2009; 10: 147. 9. Tzeng DS, Lian LC, Chang CU, Yang CY, Lee GT, Pan P, Lung FW. Healthcare in schizophrenia: effectiveness and progress of a redesigned care network. BMC Health Serv Res. 2007; 7: 129. 10. American Psychiatric Association. Diagnostic and statistical manual of mental disorders, 5th ed. American Psychiatric Assoc
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PAL-TWN-MA2 (Johnson & Johnson Taiwan Ltd)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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