Symptomatic Remission and Social Function in Patients Treated With Paliperidone ER
The purpose of this study is to explore the relationship between achieving symptomatic remission status by means of the 8 items of Positive and Negative Syndrome Scale (PANSS), and personal and social functioning by means of the Personal and Social Performance (PSP) scale in patients treated with flexibly dosed Paliperidone ER.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Symptomatic Remission and Social Function in Patients Treated With Paliperidone ER|
- Change from baseline in Positive and Negative Syndrome Scale (PANSS) [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items. Higher scores indicate worsening.
- Change from baseline in Personal and Social Performance (PSP) Scale [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]This scale assesses the degree of difficulty a patient 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. The score ranges from 1 to 100, divided into 10 equal intervals to rate the degree of difficulty (i, absent to vi, very severe) in each of the 4 domains. Patients with scores of 71 to 100 have a mild degree of difficulty; from 31 to 70, varying degrees of disability; ≤ 30, functioning so poorly as to require intensive supervision.
|Study Start Date:||July 2008|
|Study Completion Date:||June 2009|
|Primary Completion Date:||June 2009 (Final data collection date for primary outcome measure)|
|Experimental: Paliperidone ER||
Drug: Paliperidone ER
Type= exact number, unit= mg, number= 6, form= tablet, route= oral use. The recommended paliperidone ER dose is 6 mg once daily. Some patients may benefit from lower or higher doses in the recommended dose range of 3 to 12 mg once daily.
This is an open label (all people know the identity of the intervention), multicenter, 12-week study. Patients can be either in- or outpatients. Throughout the study flexible dosing of paliperidone extended release (ER) in a range of 3 to 12 mg/day may be used. Flexible dosing will allow investigators to individually adjust the dosage of each patient. The recommended dose of paliperidone ER is 6 mg once daily.