Symptomatic Remission and Social Function in Participants Treated With Paliperidone Extended Release (ER)

• Sponsor: Johnson & Johnson Taiwan Ltd (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01577186
• Collaborator: (none)
• Enrollment: 480
• Arm: 1
• Duration (Months): 11

Study Details

Study Description

Brief Summary

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 participants treated with flexibly dosed paliperidone ER.

Condition or Disease	Intervention/Treatment	Phase
Schizophrenia	Drug: Paliperidone ER	Phase 4

Detailed Description

This is an open label (all people know the identity of the intervention), multicenter (when more than one hospital or medical school team work on a medical research study) and prospective (study following participants forward in time) 12-week study. Participants can be either in- or outpatients. The total study duration will be 12 weeks for each participant and will include following visits: Screening, Week 0, 4, 8, and 12 (end of treatment or early withdrawal). Throughout the study, participants will receive paliperidone ER in a flexible dosing range of 3 to 12 milligram per day (mg/day). Efficacy will primarily be evaluated by PANSS and PSP scale. Participants' safety will also be monitored throughout the study.

Study Design

• Study Type: Interventional
• Actual Enrollment: 480 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Symptomatic Remission and Social Function in Patients Treated With Paliperidone ER
• Study Start Date: Jul 1, 2008
• Actual Primary Completion Date: Jun 1, 2009
• Actual Study Completion Date: Jun 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Paliperidone Extended Release (ER)	Drug: Paliperidone ER; Participants will receive paliperidone ER tablet in flexible dose range of 3 to 12 milligram per day (mg/day) orally once daily up to Week 12 as per Investigator's discretion.

Outcome Measures

Primary Outcome Measures

1. Percentage of Participants Achieving Symptomatic Remission by Means of Positive and Negative Syndrome Scale (PANSS) [End of study (Up to Week 12)]

   The PANSS is a 30-item scale to assess the neuropsychiatric symptoms of schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self). The PANSS provides a total score and scores for 3 subscales, the positive subscale (7 items), the negative subscale (7 items), and the general psychopathology subscale (16 items), each item scored on a scale of 1 (absent), 2 (minimal), 3 (mild), 4 (moderate), 5 (moderately severe), 6 (severe) and 7 (extreme). The total score ranges from 30 to 210 and higher score indicates greater severity. Symptomatic remission was defined as achieving intensity level of mild or moderate on PANSS scale by all 8 items as the determinants for symptomatic remission: delusions, unusual thought content, hallucinatory behavior, conceptual disorganization, mannerisms/posturing, blunted affect, social withdrawal, lack of spontaneity.

2. Percentage of Participants Achieving Improvement in Personal and Social Performance (PSP) Score by at Least One Category on PSP Scale [End of study (Up to Week 12)]

   The PSP is 100-point validated clinician-rated scale that assesses degree of difficulty in 4 areas of functioning: socially useful activities, personal and social relationships, self-care, disturbing and aggressive behaviors rated on 6-point scale (1=absent to 6=very severe).Total transformed score from 1 to 100 is generated from raw score based on clinical interpretation of scores generated in 4 areas of functioning, with higher transformed score indicating better function. Total score is divided into 3 levels: 71-100 (mild difficulty); 31-70 (marked difficulty) and 1-30 (severe difficulty). Percentage of participants achieving improvement in PSP score by at least one category was reported.

Secondary Outcome Measures

1. Social Functioning Scale (SFS) Score [End of study (Up to Week 12)]

   The SFS is a 36-item scale designed to assess social functioning in schizophrenia. It assesses abilities and performance in seven areas: social engagement, interpersonal communication, activities of daily living, recreation, social activities, competence at independent living, and occupation/employment. Total score ranges from 1 to 100 where higher score indicates a more favorable health state.

Other Outcome Measures

1. Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 12 [Baseline, Week 12]

   The PANSS is a 30-item scale to assess the neuropsychiatric symptoms of schizophrenia. The PANSS provides a total score and scores for 3 subscales, the positive subscale (7 items), the negative subscale (7 items), and the general psychopathology subscale (16 items), each item scored on a scale of 1 (absent) to 7 (extreme). The total score ranges from 30 to 210 and higher score indicates greater severity.

2. Change From Baseline in Total Personal and Social Performance (PSP) Score at Week 12 [Baseline, Week 12]

   The PSP is 100-point validated clinician-rated scale that assesses degree of difficulty in 4 areas of functioning: socially useful activities, personal and social relationships, self-care, disturbing and aggressive behaviors rated on 6-point scale (1=absent to 6=very severe).Total transformed score from 1 to 100 is generated from raw score based on clinical interpretation of scores generated in 4 areas of functioning, with higher transformed score indicating better function. Total score is divided into 3 levels: 71-100 (mild difficulty); 31-70 (marked difficulty) and 1-30 (severe difficulty).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Participants who meet the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV) criteria for schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self)

• Participant is drug naive or participant's previous treatment is considered unsuccessful due to one or more of the following reasons: lack of efficacy, lack of tolerability or safety, lack of compliance and/or other reasons

• Participants or their legally acceptable representatives had signed an informed consent document indicating that they understand the purpose of and procedures required for the study and were willing to participate in the study

• Women must be postmenopausal for at least 1 year, surgically sterile, abstinent, or, if sexually active, agree to practice an effective method of birth control before entry and throughout the study and must have a negative urine pregnancy test at screening

Exclusion Criteria:

• Participants with use of clozapine, paliperidone extended release (ER), any conventional depot neuroleptic or Risperdal CONSTA during the last 3 months

• Participants with serious unstable medical condition, including known clinically relevant laboratory abnormalities

• Participants with history of neuroleptic malignant syndrome (high fever, rigid muscles, shaking, confusion, sweating more than usual, increased heart rate or blood pressure, or muscle pain or weakness)

• Participants with known hypersensitivity to paliperidone ER or risperidone

• Participants with inability to swallow the whole study medication tablet with aid of water

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Johnson & Johnson Taiwan Ltd

Investigators

• Study Director: Johnson & Johnson Taiwan Ltd Clinical Trial, Johnson & Johnson Taiwan Ltd

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Johnson & Johnson Taiwan Ltd
• ClinicalTrials.gov Identifier: NCT01577186
• Other Study ID Numbers: CR015667; R076477SCH4035; PAL-TWN-MA3
• First Posted: Apr 13, 2012
• Last Update Posted: Jan 17, 2014
• Last Verified: Dec 1, 2013

• Keywords provided by Johnson & Johnson Taiwan Ltd: Schizophrenia; Paliperidone Extended Release
• Additional relevant MeSH terms: Schizophrenia; Paliperidone Palmitate

Study Results

Participant Flow

Arm/Group Title	Paliperidone ER
Arm/Group Description	Participants received paliperidone ER tablet in flexible dose range of 3 to 12 milligram per day orally once daily up to Week 12 as per Investigator's discretion.
Period Title: Overall Study
STARTED	480
COMPLETED	350
NOT COMPLETED	130

Baseline Characteristics

Arm/Group Title	Paliperidone ER
Arm/Group Description	Participants received paliperidone ER tablet in flexible dose range of 3 to 12 milligram per day orally once daily up to Week 12 as per Investigator's discretion.
Overall Participants	480
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	40.3 (10.62)
Sex: Female, Male (Count of Participants)
Female	218 45.4%
Male	262 54.6%

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants Achieving Symptomatic Remission by Means of Positive and Negative Syndrome Scale (PANSS)
Description	The PANSS is a 30-item scale to assess the neuropsychiatric symptoms of schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self). The PANSS provides a total score and scores for 3 subscales, the positive subscale (7 items), the negative subscale (7 items), and the general psychopathology subscale (16 items), each item scored on a scale of 1 (absent), 2 (minimal), 3 (mild), 4 (moderate), 5 (moderately severe), 6 (severe) and 7 (extreme). The total score ranges from 30 to 210 and higher score indicates greater severity. Symptomatic remission was defined as achieving intensity level of mild or moderate on PANSS scale by all 8 items as the determinants for symptomatic remission: delusions, unusual thought content, hallucinatory behavior, conceptual disorganization, mannerisms/posturing, blunted affect, social withdrawal, lack of spontaneity.
Time Frame	End of study (Up to Week 12)

Outcome Measure Data

Analysis Population Description

Intent-to-treat (ITT) population included all participants who received at least 1 dose of study drug and had at least one post-baseline assessment.

Arm/Group Title	Paliperidone Extended Release (ER)
Arm/Group Description	Participants received paliperidone ER tablet in flexible dose range of 3 to 12 milligram per day orally once daily up to Week 12.as per Investigator's discretion.
Measure Participants	426
Number (95% Confidence Interval) [percentage of participants]	11.74 2.4%

2. Secondary Outcome

Title	Social Functioning Scale (SFS) Score
Description	The SFS is a 36-item scale designed to assess social functioning in schizophrenia. It assesses abilities and performance in seven areas: social engagement, interpersonal communication, activities of daily living, recreation, social activities, competence at independent living, and occupation/employment. Total score ranges from 1 to 100 where higher score indicates a more favorable health state.
Time Frame	End of study (Up to Week 12)

Outcome Measure Data

Analysis Population Description

ITT population included all participants who received at least 1 dose of study drug and had at least one post-baseline assessment. Here 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.

Arm/Group Title	Paliperidone Extended Release (ER)
Arm/Group Description	Participants received paliperidone ER tablet in flexible dose range of 3 to 12 milligram per day orally once daily up to Week 12.as per Investigator's discretion.
Measure Participants	374
Mean (Standard Deviation) [units on a scale]	44.99 (19.05)

3. Primary Outcome

Title	Percentage of Participants Achieving Improvement in Personal and Social Performance (PSP) Score by at Least One Category on PSP Scale
Description	The PSP is 100-point validated clinician-rated scale that assesses degree of difficulty in 4 areas of functioning: socially useful activities, personal and social relationships, self-care, disturbing and aggressive behaviors rated on 6-point scale (1=absent to 6=very severe).Total transformed score from 1 to 100 is generated from raw score based on clinical interpretation of scores generated in 4 areas of functioning, with higher transformed score indicating better function. Total score is divided into 3 levels: 71-100 (mild difficulty); 31-70 (marked difficulty) and 1-30 (severe difficulty). Percentage of participants achieving improvement in PSP score by at least one category was reported.
Time Frame	End of study (Up to Week 12)

Outcome Measure Data

Analysis Population Description

ITT population included all participants who received at least 1 dose of study drug and had at least one post-baseline assessment.

Arm/Group Title	Paliperidone Extended Release (ER)
Arm/Group Description	Participants received paliperidone ER tablet in flexible dose range of 3 to 12 milligram per day orally once daily up to Week 12.as per Investigator's discretion.
Measure Participants	426
Number (95% Confidence Interval) [percentage of participants]	47.42 9.9%

4. Other Pre-specified Outcome

Title	Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 12
Description	The PANSS is a 30-item scale to assess the neuropsychiatric symptoms of schizophrenia. The PANSS provides a total score and scores for 3 subscales, the positive subscale (7 items), the negative subscale (7 items), and the general psychopathology subscale (16 items), each item scored on a scale of 1 (absent) to 7 (extreme). The total score ranges from 30 to 210 and higher score indicates greater severity.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

ITT population included all participants who received at least 1 dose of study drug and had at least one post-baseline assessment. Here, 'n' signifies those participants who were evaluable for this outcome measure at specified time point.

Arm/Group Title	Paliperidone Extended Release (ER)
Arm/Group Description	Participants received paliperidone ER tablet in flexible dose range of 3 to 12 milligram per day orally once daily up to Week 12.as per Investigator's discretion.
Measure Participants	426
Baseline (n=426)	89.88 (29.60)
Change at Week 12 (n=350)	-16.07 (19.64)

5. Other Pre-specified Outcome

Title	Change From Baseline in Total Personal and Social Performance (PSP) Score at Week 12
Description	The PSP is 100-point validated clinician-rated scale that assesses degree of difficulty in 4 areas of functioning: socially useful activities, personal and social relationships, self-care, disturbing and aggressive behaviors rated on 6-point scale (1=absent to 6=very severe).Total transformed score from 1 to 100 is generated from raw score based on clinical interpretation of scores generated in 4 areas of functioning, with higher transformed score indicating better function. Total score is divided into 3 levels: 71-100 (mild difficulty); 31-70 (marked difficulty) and 1-30 (severe difficulty).
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

ITT population included all participants who received at least 1 dose of study drug and had at least one post-baseline assessment. Here, 'n' signifies those participants who were evaluable for this outcome measure at specified time point.

Arm/Group Title	Paliperidone Extended Release (ER)
Arm/Group Description	Participants received paliperidone ER tablet in flexible dose range of 3 to 12 milligram per day orally once daily up to Week 12.as per Investigator's discretion.
Measure Participants	426
Baseline (n=426)	47.07 (16.34)
Change at Week 12 (n=350)	9.05 (12.55)

Adverse Events

Time Frame	12 weeks
Arm/Group Title	Paliperidone ER
Arm/Group Description	Participants received paliperidone ER tablet in flexible dose range of 3 to 12 milligram per day orally once daily up to Week 12 as per Investigator's discretion.
All Cause Mortality
	Paliperidone ER
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Paliperidone ER
	Affected / at Risk (%)	# Events
Total	37/480 (7.7%)
Cardiac disorders
Supraventricular Tachycardia	1/480 (0.2%)
Infections and infestations
Pulmonary Tuberculosis	1/480 (0.2%)
Injury, poisoning and procedural complications
Femur Fracture	1/480 (0.2%)
Psychiatric disorders
Aggression	1/480 (0.2%)
Alcohol Abuse	1/480 (0.2%)
Completed Suicide	1/480 (0.2%)
Drug Abuse	1/480 (0.2%)
Hallucination, Auditory	2/480 (0.4%)
Impulsive Behaviour	1/480 (0.2%)
Insomnia	1/480 (0.2%)
Major Depression	1/480 (0.2%)
Schizophrenia	27/480 (5.6%)
Suicide Attempt	1/480 (0.2%)
Reproductive system and breast disorders
Scrotal Ulcer	1/480 (0.2%)
Other (Not Including Serious) Adverse Events
	Paliperidone ER
	Affected / at Risk (%)	# Events
Total	169/480 (35.2%)
Gastrointestinal disorders
Constipation	15/480 (3.1%)
Infections and infestations
Nasopharyngitis	11/480 (2.3%)
Upper Respiratory Tract Infection	32/480 (6.7%)
Investigations
Weight Increased	14/480 (2.9%)
Nervous system disorders
Dizziness	20/480 (4.2%)
Extrapyramidal Disorder	56/480 (11.7%)
Headache	10/480 (2.1%)
Somnolence	10/480 (2.1%)
Tremor	23/480 (4.8%)
Psychiatric disorders
Anxiety	12/480 (2.5%)
Insomnia	21/480 (4.4%)

Limitations/Caveats

Some Adverse Events summaries were reported based on estimates due to the fact that they were not prepared in the original study report and the relevant definitions of the data elements were not available for these summaries to be regenerated.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.