Phase 4 Study to Evaluate Efficacy of Paliperidone Extended-Release(ER) in Schizophrenic Participants

An Open-label Prospective, Non-comparative Study to Evaluate the Subjective Experiences Upon Transition to Paliperidone Extended Release(ER) in Subjects With Schizophrenia

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00761605

Acronym

PASS

Enrollment

387

Registered

2008-09-29

Start date

2008-04-30

Completion date

2010-10-31

Last updated

2014-09-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizophrenia

Keywords

Schizophrenia, Paliperidone, Paliperidone extended-release, Antipsychotics Agents

Brief summary

The purpose of this study is to investigate the efficacy of flexibly dosed paliperidone extended-release (mechanism to dissolve a drug over time in order to be released slower and steadier into the blood stream) in improving or maintaining the subjective symptoms of the participants in three participants' groups (that is, by the reason to switch: lack of efficacy group, lack of tolerability group, and lack of compliance group) who switched from other previous antipsychotic drugs to paliperidone extended-release tablets at flexible doses.

Detailed description

This is an open-label (all people know the identity of the intervention), prospective (study following participants forward in time), single arm, and non-comparative study of paliperidone Extended-release (ER) in participants switching from the previous oral antipsychotic to flexibly dosed paliperidone ER. The total study duration will be approximately of 24 weeks per participant. The study consists of 2 parts: Screening (that is, 14 days before study commences on Day 1); Treatment (24 weeks). Efficacy will primarily be evaluated by change from baseline in symptom checklist 90-R (SCL90-R) at Week 24. Participants' safety will be monitored throughout the study.

Interventions

DRUGPaliperidone

Paliperidone oral tablet will be administered once daily at a dose of 6 milligram (mg) for 24 weeks, wherein dose range was 3 to 12 mg per day.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

* Childbearing potential women who consent to the use of the consistently permissible contraception (oral contraceptive, contraceptive injection, intrauterine device, double barrier method and contraceptive patch) * Participants who are compliant with self-medication or can receive consistent help or support * Participants who need to change the antipsychotic drug to another one for the following reasons among the participants treated with an antipsychotic drug for more than two weeks before the screening (1) Group of lack of efficacy: The antipsychotic drug is clinically required to be changed because there is no or little therapeutic response despite the appropriately dosed antipsychotic therapy (2) Group of lack of tolerance: The antipsychotic drug is required to be changed due to lack of tolerance to the existing antipsychotic drug or the safety issue (3) Group of lack of compliance: The antipsychotic drug is required to be changed due to lack of medication compliance or the participant wants to change the antipsychotic drug)

Exclusion criteria

* Participants with the past history of neuroleptic malignant syndrome (NMS) * Participants who are suspicious of having clinically significant risk including suicide or aggressive behavior and are expected to unable to complete the study (based on the investigator's judgment) * Participants with severe preexisting gastrointestinal narrowing (pathologic or iatrogenic) or participants who cannot swallow the drug whole (The study drug must not be chewed, divided, melted or grinded because it can impact the study drug release profile * Female participants who are pregnant or are breast feeding * Participants who have participated in any investigational drug trial within 1 month prior to the screening visit

Design outcomes

Primary

Measure	Time frame	Description
Change From Baseline in Symptom Checklist 90-R (SCL90-R) at Week 24	Baseline and Week 24	The SCL90-R (Derogatis, 1992) measures 9 domains, including somatization, obsessive-compulsive, interpersonal sensitivity, depression, anxiety, hostility, phobic anxiety, paranoid ideation, psychoticism, which provides a global index of distress, the Global Severity Index (GSI). SCL-90-R includes 90 items rated on 5-point scale, ranging from 0 (not at all) to 4 (extremely). Total scale score range from 0 to 360. Higher scores indicate worsening of disease. Change from Baseline was calculated as value at Baseline minus value at Week 24. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.

Secondary

Measure	Time frame	Description
Change From Baseline in Subjective Well-being Under Neuroleptic (SWN-20) Scale at Week 24	Baseline and Week 24	The SWN-20 scale is a 20 item scale that was originally designed to explore the subjective experience of psychotic participants. The SWN scale contains five sub-scales consisting of four items each: mental functioning (MF), self-control (SC), emotional regulation (ER), and social integration (SI), physical functioning (PF). The total score ranges from a minimum of 20 (poor subjective experience) to a maximum of 120 (excellent subjective experience). SWN scores appear to correlate with measure of objective psychopathology, quality of life and other self-ratings of mood. Change from Baseline was calculated as value at Baseline minus value at Week 24. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.
Change From Baseline in Sleep Quality Based on Visual Analog Scale at Week 24	Baseline and Week 24	Sleep quality was assessed by an 11-point visual analog scale. Participants indicated on the 11-point visual analog scale (score ranging from 0 to 100 millimeter) how well they have slept in the previous 7 days, from 0 (very badly) to 100 (very well); and how often they have felt drowsy within the previous 7 days, from 0 (not at all) to 100 (all the time). Scores were averaged for the previous 7 days. Change from Baseline was calculated as value at Baseline minus value at Week 24. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.
Change From Baseline in Daytime Drowsiness Based on Visual Analog Scale at Week 24	Baseline and Week 24	Daytime Drowsiness was assessed by an 11-point visual analog scale. Participants indicated on the 11-point visual analog scale (score ranging from 0 to 100 millimeter) how well they have slept in the previous 7 days, from 0 (very badly) to 100 (very well); and how often they have felt drowsy within the previous 7 days, from 0 (not at all) to 100 (all the time). Scores were averaged for the previous 7 days. Change from Baseline was calculated as value at Baseline minus value at Week 24. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.
Change From Baseline in Total Personal and Social Performance (PSP) Score at Week 24	Baseline and Week 24	The PSP scale assesses the degree of dysfunction 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 (1, absent to 6, very severe) in each of the 4 domains. Participants with a score of 71 to 100 have a mild degree of difficulty; from 31 to 70, varying degrees of disability; less or equal to 30, functioning so poorly as to require intensive supervision. Change from Baseline was calculated as value at Baseline minus value at Week 24. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.
Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score at Week 24	Baseline and Week 24	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. Change from Baseline was calculated as value at Baseline minus value at Week 24. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.
Change From Baseline in Clinical Global Impression - Improvement (CGI-I) Score at Week 24	Baseline and Week 24	The CGI-I is a 7-point scale that requires the clinician to assess how much the participant's illness has improved or worsened relative to a baseline state at the beginning of the intervention and rated as: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse. Change from Baseline was calculated as value at Baseline minus value at Week 24. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.
Change From Baseline in Krawiecka Scale Score at Week 24	Baseline and Week 24	Psychopathology of participants was assessed by Krawiecka scale. Psychopathology of participants was assessed by Krawiecka scale, score ranges from 0 to 16. Higher score indicates worsening of disease. Change from Baseline was calculated as value at Baseline minus value at Week 24. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.

Countries

South Korea

Participant flow

Participants by arm

Arm	Count
Paliperidone Paliperidone oral tablet was administered once daily at a dose of 6 milligram (mg) for 24 weeks, wherein dose range was 3 to 12 mg per day.	387
Total	387

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Adverse Event	26
Overall Study	Death	2
Overall Study	Lack of Efficacy	26
Overall Study	Lost to Follow-up	29
Overall Study	Other	21
Overall Study	Withdrawal by Subject	37

Baseline characteristics

Characteristic	Paliperidone
Age, Continuous	36.73 years STANDARD_DEVIATION 10.97
Sex: Female, Male Female	214 Participants
Sex: Female, Male Male	173 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	— / —
other Total, other adverse events	209 / 387
serious Total, serious adverse events	38 / 387

Outcome results

Primary

Change From Baseline in Symptom Checklist 90-R (SCL90-R) at Week 24

The SCL90-R (Derogatis, 1992) measures 9 domains, including somatization, obsessive-compulsive, interpersonal sensitivity, depression, anxiety, hostility, phobic anxiety, paranoid ideation, psychoticism, which provides a global index of distress, the Global Severity Index (GSI). SCL-90-R includes 90 items rated on 5-point scale, ranging from 0 (not at all) to 4 (extremely). Total scale score range from 0 to 360. Higher scores indicate worsening of disease. Change from Baseline was calculated as value at Baseline minus value at Week 24. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.