Trial Outcomes & Findings for Symptomatic Remission and Social Function in Participants Treated With Paliperidone Extended Release (ER) (NCT NCT01577186)
NCT ID: NCT01577186
Last Updated: 2014-01-17
Results Overview
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.
COMPLETED
PHASE4
480 participants
End of study (Up to Week 12)
2014-01-17
Participant Flow
Participant milestones
| Measure |
Paliperidone ER
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 Study
STARTED
|
480
|
|
Overall Study
COMPLETED
|
350
|
|
Overall Study
NOT COMPLETED
|
130
|
Reasons for withdrawal
| Measure |
Paliperidone ER
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 Study
Adverse Event
|
23
|
|
Overall Study
Death
|
1
|
|
Overall Study
Lost to Follow-up
|
28
|
|
Overall Study
Withdrawal by Subject
|
35
|
|
Overall Study
Insufficient Response
|
18
|
|
Overall Study
Ineligible to Continue
|
15
|
|
Overall Study
Non-Compliant
|
8
|
|
Overall Study
Other
|
2
|
Baseline Characteristics
Symptomatic Remission and Social Function in Participants Treated With Paliperidone Extended Release (ER)
Baseline characteristics by cohort
| Measure |
Paliperidone ER
n=480 Participants
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.
|
|---|---|
|
Age, Continuous
|
40.3 years
STANDARD_DEVIATION 10.62 • n=93 Participants
|
|
Sex: Female, Male
Female
|
218 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
262 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: End of study (Up to Week 12)Population: 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.
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.
Outcome measures
| Measure |
Paliperidone Extended Release (ER)
n=426 Participants
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.
|
|---|---|
|
Percentage of Participants Achieving Symptomatic Remission by Means of Positive and Negative Syndrome Scale (PANSS)
|
11.74 percentage of participants
Interval 8.84 to 15.18
|
PRIMARY outcome
Timeframe: End of study (Up to Week 12)Population: ITT population included all participants who received at least 1 dose of study drug and had at least one post-baseline assessment.
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.
Outcome measures
| Measure |
Paliperidone Extended Release (ER)
n=426 Participants
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.
|
|---|---|
|
Percentage of Participants Achieving Improvement in Personal and Social Performance (PSP) Score by at Least One Category on PSP Scale
|
47.42 percentage of participants
Interval 42.59 to 52.28
|
SECONDARY outcome
Timeframe: End of study (Up to Week 12)Population: 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.
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.
Outcome measures
| Measure |
Paliperidone Extended Release (ER)
n=374 Participants
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.
|
|---|---|
|
Social Functioning Scale (SFS) Score
|
44.99 units on a scale
Standard Deviation 19.05
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Week 12Population: 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.
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.
Outcome measures
| Measure |
Paliperidone Extended Release (ER)
n=426 Participants
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.
|
|---|---|
|
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 12
Baseline (n=426)
|
89.88 units on a scale
Standard Deviation 29.60
|
|
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 12
Change at Week 12 (n=350)
|
-16.07 units on a scale
Standard Deviation 19.64
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Week 12Population: 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.
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).
Outcome measures
| Measure |
Paliperidone Extended Release (ER)
n=426 Participants
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.
|
|---|---|
|
Change From Baseline in Total Personal and Social Performance (PSP) Score at Week 12
Baseline (n=426)
|
47.07 units on a scale
Standard Deviation 16.34
|
|
Change From Baseline in Total Personal and Social Performance (PSP) Score at Week 12
Change at Week 12 (n=350)
|
9.05 units on a scale
Standard Deviation 12.55
|
Adverse Events
Paliperidone ER
Serious adverse events
| Measure |
Paliperidone ER
n=480 participants at risk
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.
|
|---|---|
|
Cardiac disorders
Supraventricular Tachycardia
|
0.21%
1/480 • 12 weeks
|
|
Infections and infestations
Pulmonary Tuberculosis
|
0.21%
1/480 • 12 weeks
|
|
Injury, poisoning and procedural complications
Femur Fracture
|
0.21%
1/480 • 12 weeks
|
|
Psychiatric disorders
Aggression
|
0.21%
1/480 • 12 weeks
|
|
Psychiatric disorders
Alcohol Abuse
|
0.21%
1/480 • 12 weeks
|
|
Psychiatric disorders
Completed Suicide
|
0.21%
1/480 • 12 weeks
|
|
Psychiatric disorders
Drug Abuse
|
0.21%
1/480 • 12 weeks
|
|
Psychiatric disorders
Hallucination, Auditory
|
0.42%
2/480 • 12 weeks
|
|
Psychiatric disorders
Impulsive Behaviour
|
0.21%
1/480 • 12 weeks
|
|
Psychiatric disorders
Insomnia
|
0.21%
1/480 • 12 weeks
|
|
Psychiatric disorders
Major Depression
|
0.21%
1/480 • 12 weeks
|
|
Psychiatric disorders
Schizophrenia
|
5.6%
27/480 • 12 weeks
|
|
Psychiatric disorders
Suicide Attempt
|
0.21%
1/480 • 12 weeks
|
|
Reproductive system and breast disorders
Scrotal Ulcer
|
0.21%
1/480 • 12 weeks
|
Other adverse events
| Measure |
Paliperidone ER
n=480 participants at risk
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.
|
|---|---|
|
Gastrointestinal disorders
Constipation
|
3.1%
15/480 • 12 weeks
|
|
Infections and infestations
Nasopharyngitis
|
2.3%
11/480 • 12 weeks
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
6.7%
32/480 • 12 weeks
|
|
Investigations
Weight Increased
|
2.9%
14/480 • 12 weeks
|
|
Nervous system disorders
Dizziness
|
4.2%
20/480 • 12 weeks
|
|
Nervous system disorders
Extrapyramidal Disorder
|
11.7%
56/480 • 12 weeks
|
|
Nervous system disorders
Headache
|
2.1%
10/480 • 12 weeks
|
|
Nervous system disorders
Somnolence
|
2.1%
10/480 • 12 weeks
|
|
Nervous system disorders
Tremor
|
4.8%
23/480 • 12 weeks
|
|
Psychiatric disorders
Anxiety
|
2.5%
12/480 • 12 weeks
|
|
Psychiatric disorders
Insomnia
|
4.4%
21/480 • 12 weeks
|
Additional Information
Medical Director
Janssen Research & Development
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60