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Paliperidone Extended Release in Schizophrenia Participants With Duration of Illness Less Than 10 Years

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ClinicalTrials.gov Identifier: NCT01362439
Recruitment Status : Completed
First Posted : May 30, 2011
Results First Posted : June 5, 2013
Last Update Posted : June 5, 2013
Sponsor:
Information provided by (Responsible Party):
Janssen-Cilag S.p.A.

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Schizophrenia
Intervention Drug: Paliperidone ER
Enrollment 133
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Paliperidone ER
Hide Arm/Group Description Participants were administered paliperidone extended release (ER) tablets orally (taken by mouth; to be swallowed) once daily in the dose range of 3 to 12 milligram (mg) for 13 weeks. Dose was increased or decreased as per Investigator's discretion.
Period Title: Overall Study
Started 133
Completed 118
Not Completed 15
Reason Not Completed
Adverse Event             1
Lack of Efficacy             3
Lost to Follow-up             2
Study medication non-compliant             1
Participant who withdrew consent             8
Arm/Group Title Paliperidone ER
Hide Arm/Group Description Participants were administered paliperidone extended release (ER) tablets orally (taken by mouth; to be swallowed) once daily in the dose range of 3 to 12 milligram (mg) for 13 weeks. Dose was increased or decreased as per Investigator's discretion.
Overall Number of Baseline Participants 132
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 132 participants
35.3  (6.76)
[1]
Measure Description: Out of a total of 133 participants, Baseline characteristic (Age) was available for only 132 participants who were included in intent to treat (ITT) population.
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 132 participants
Female
41
  31.1%
Male
91
  68.9%
[1]
Measure Description: Out of a total of 133 participants, Baseline characteristic (Gender) was available for only 132 participants who were included in ITT population.
1.Primary Outcome
Title Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Total Score at Week 13
Hide Description The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self) 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 and ranges from 30 to 210, higher scores indicate worsening.
Time Frame Baseline and Week 13
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat Population (ITT) included all participants who received at least 1 dose of study medication. For participants leaving study prematurely last available data post-baseline was used for final evaluation using Last observation carried forward (LOCF) method.' N' (number of participants analyzed): participants evaluable for this measure.
Arm/Group Title Paliperidone ER
Hide Arm/Group Description:
Participants were administered paliperidone extended release (ER) tablets orally (taken by mouth; to be swallowed) once daily in the dose range of 3 to 12 milligram (mg) for 13 weeks. Dose was increased or decreased as per Investigator's discretion.
Overall Number of Participants Analyzed 126
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 88.98  (10.126)
Change at Week 13 22.468  (17.287)
2.Secondary Outcome
Title Change in Positive and Negative Syndrome Scale (PANSS) - Positive Subscale Score at Week 13
Hide Description The PANSS Positive Subscale assesses seven positive-symptoms of schizophrenia. Positive symptoms refer to an excess or distortion of normal functions. The symptoms are rated on a 7-point scale, with a range of 7 (absent) to 49 (extreme psychopathology).
Time Frame Baseline and Week 13
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT included all participants who received at least one dose of study medication. For participants leaving study prematurely last available data post-baseline was used for final evaluation using LOCF method.
Arm/Group Title Paliperidone ER
Hide Arm/Group Description:
Participants were administered paliperidone ER tablets orally (taken by mouth; to be swallowed) once daily in the dose range of 3 to 12 mg for 13 weeks. Dose was increased or decreased as per Investigator's discretion.
Overall Number of Participants Analyzed 132
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 21.03  (5.2)
Change at Week 13 -6.55  (5.3)
3.Secondary Outcome
Title Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Negative Subscale Score at Week 13
Hide Description The PANSS Negative Subscale assesses seven negative-symptoms of schizophrenia. Negative symptoms represent a diminution or loss of normal functions. The symptoms are rated on a 7-point scale, with a range of 7 (absent) to 49 (extreme psychopathology).
Time Frame Baseline and Week 13
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT included all participants who received at least one dose of study medication. For participants leaving study prematurely last available data post-baseline was used for final evaluation using LOCF method.
Arm/Group Title Paliperidone ER
Hide Arm/Group Description:
Participants were administered paliperidone ER tablets orally (taken by mouth; to be swallowed) once daily in the dose range of 3 to 12 mg for 13 weeks. Dose was increased or decreased as per Investigator's discretion.
Overall Number of Participants Analyzed 132
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 23.11  (6.4)
Change at Week 13 -4.82  (5.6)
4.Secondary Outcome
Title Change in Positive and Negative Syndrome Scale (PANSS) General Psychopathology Subscale Score at Week 13
Hide Description The PANSS General Psychopathology Subscale Score assesses 16 general psychopathology symptoms. The symptoms are rated on a 7-point scale, with a range of 16 (absent) to 112 (extreme psychopathology).
Time Frame Baseline and Week 13
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT included all participants who received at least one dose of study medication. For participants leaving study prematurely last available data post-baseline was used for final evaluation using LOCF method.
Arm/Group Title Paliperidone ER
Hide Arm/Group Description:
Participants were administered paliperidone ER tablets orally (taken by mouth; to be swallowed) once daily in the dose range of 3 to 12 mg for 13 weeks. Dose was increased or decreased as per Investigator's discretion.
Overall Number of Participants Analyzed 132
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 44.84  (6.5)
Change at Week 13 -11.31  (8.7)
5.Secondary Outcome
Title Percentage of Participants With Greater Than or Equal to 30 Percent Treatment Response in Total Positive and Negative Syndrome Scale (PANSS) Score
Hide Description The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self) 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 and ranges from 30 to 210, higher scores indicate worsening.
Time Frame Baseline and Week 13
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT included all participants who received at least one dose of study medication. For participants leaving study prematurely last available data post-baseline was used for final evaluation using LOCF method. 'N' (number of participants analyzed) signified participants evaluable for this measure.
Arm/Group Title Paliperidone ER
Hide Arm/Group Description:
Participants were administered paliperidone ER tablets orally (taken by mouth; to be swallowed) once daily in the dose range of 3 to 12 mg for 13 weeks. Dose was increased or decreased as per Investigator's discretion.
Overall Number of Participants Analyzed 126
Measure Type: Number
Unit of Measure: percentage of participants
40.5
6.Secondary Outcome
Title Change From Baseline in Subjective Well-being Under Neuroleptic (SWN 20) Scale at Week 13
Hide Description 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.
Time Frame Baseline and Week 13
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT included all participants who received at least one dose of study medication. For participants leaving study prematurely last available data post-baseline was used for final evaluation using LOCF method.
Arm/Group Title Paliperidone ER
Hide Arm/Group Description:
Participants were administered paliperidone ER tablets orally (taken by mouth; to be swallowed) once daily in the dose range of 3 to 12 mg for 13 weeks. Dose was increased or decreased as per Investigator's discretion.
Overall Number of Participants Analyzed 132
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 73.81  (15.4)
Change at Week 13 6.86  (12.8)
7.Secondary Outcome
Title Change From Baseline in Drug Attitude Inventory (DAI 30) Scale at Week 13
Hide Description The DAI is a 30-item self-rating inventory that focuses on subjective effects of neuroleptic medications in participants with schizophrenia. There are 15 items that are scored as true and 15 scored as false if the person is fully compliant (positive subjective response). Positive answers score as +1, negative answers score as – 1. Questionnaire allows identifying participants at high risk of low compliance. The total score may vary from -30 to +30 with a high total final score is a positive subjective response (compliant) and a low total score is a negative subjective response (non-compliant).
Time Frame Baseline and Week 13
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT included all participants who received at least one dose of study medication. For participants leaving study prematurely last available data post-baseline was used for final evaluation using LOCF method.
Arm/Group Title Paliperidone ER
Hide Arm/Group Description:
Participants were administered paliperidone ER tablets orally (taken by mouth; to be swallowed) once daily in the dose range of 3 to 12 mg for 13 weeks. Dose was increased or decreased as per Investigator's discretion.
Overall Number of Participants Analyzed 132
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 41.20  (5.4)
Change at Week 13 2.0  (5.4)
8.Secondary Outcome
Title Clinical Global Impression-Severity Scale (CGI-S)
Hide Description 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.
Time Frame Baseline and Week 13
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT included all participants who received at least one dose of study medication. For participants leaving study prematurely last available data post Baseline was used for final evaluation using LOCF method.
Arm/Group Title Paliperidone ER
Hide Arm/Group Description:
Participants were administered paliperidone ER tablets orally (taken by mouth; to be swallowed) once daily in the dose range of 3 to 12 mg for 13 weeks. Dose was increased or decreased as per Investigator's discretion.
Overall Number of Participants Analyzed 132
Median (Full Range)
Unit of Measure: units on a scale
Baseline
4
(2 to 6)
Week 13
3
(1 to 6)
9.Secondary Outcome
Title Change From Baseline in Personal and Social Performance Scale (PSP) at Week 13
Hide 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 and Week 13
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT included all participants who received at least one dose of study medication. For participants leaving study prematurely last available data post Baseline was used for final evaluation using LOCF method.
Arm/Group Title Paliperidone ER
Hide Arm/Group Description:
Participants were administered paliperidone ER tablets orally (taken by mouth; to be swallowed) once daily in the dose range of 3 to 12 mg for 13 weeks. Dose was increased or decreased as per Investigator's discretion.
Overall Number of Participants Analyzed 132
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 56.54  (12.47)
Change at Week 13 9.05  (10.5)
10.Secondary Outcome
Title Quality of Sleep Score
Hide Description This self-administered scale rates quality of sleep and daytime drowsiness. Participants indicate on an 11-point scale how well they have slept in the previous 7 days, from 0 (very badly) to 10 (very well); and how often they have felt drowsy within the previous 7 days, from 0 (not at all) to 10 (all the time). On the sleep evaluation scale, score 0 corresponds to very badly and score 10 to very well.
Time Frame Baseline and Week 13
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT included all participants who received at least one dose of study medication. For participants leaving study prematurely last available data post-baseline was used for final evaluation using LOCF method.
Arm/Group Title Paliperidone ER
Hide Arm/Group Description:
Participants were administered paliperidone ER tablets orally (taken by mouth; to be swallowed) once daily in the dose range of 3 to 12 mg for 13 weeks. Dose was increased or decreased as per Investigator's discretion.
Overall Number of Participants Analyzed 132
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 6.22  (2.5)
Week 13 7.08  (2.1)
11.Secondary Outcome
Title Daytime Drowsiness Evaluation Scale
Hide Description This self-administered scale rates quality of sleep and daytime drowsiness. Participants will indicate on an 11-point scale how well they have slept in the previous 7 days, from 0 (very badly) to 10 (very well); and how often they have felt drowsy within the previous 7 days, from 0 (not at all) to 10 (all the time).On the daytime drowsiness scale, score 0 corresponds to not at all and score 10 to all the time.
Time Frame Baseline and Week 13
Hide Outcome Measure Data
Hide Analysis Population Description
ITT included all participants who received at least one dose of study medication. For participants leaving study prematurely last available data post-baseline was used for final evaluation using LOCF method.
Arm/Group Title Paliperidone ER
Hide Arm/Group Description:
Participants were administered paliperidone ER tablets orally (taken by mouth; to be swallowed) once daily in the dose range of 3 to 12 mg for 13 weeks. Dose was increased or decreased as per Investigator's discretion.
Overall Number of Participants Analyzed 132
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 4.09  (2.4)
Week 13 3.30  (2.5)
12.Secondary Outcome
Title Extrapyramidal Symptoms Scale (ESRS) Subscale Scores and Total Scores
Hide Description Extra pyramidal symptoms attributed to antipsychotic assessed by ESRS scale. Included 4 subscales; Parkinsonism (Park),dystonia(Dyst),dyskinesia(Dysk),akathisia(Akat),12 items on 4-point scale; (0=absent-3=severe); Park (8 items); Dyst (2 items); Dysk (7 items) all 3 rated on 7-point scale (0=none/normal-6=worst). Additionally, subtotals were calculated; hyperkinesia (item 5, 6 of Park); hypokinesia (item 1-4, 7 of Park); bucco-linguo-masticatory (item 1-3 of Dysk), choreoathetoid movement (item 5, 6 of Dysk). Total score: sum of Park, Dyst & Dysk subscale, ranged from 0 (normal)-102 (severe).
Time Frame Baseline and Week 13
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who received atleast one dose of study medication.
Arm/Group Title Paliperidone ER
Hide Arm/Group Description:
Participants were administered paliperidone ER tablets orally (taken by mouth; to be swallowed) once daily in the dose range of 3 to 12 mg for 13 weeks. Dose was increased or decreased as per Investigator's discretion.
Overall Number of Participants Analyzed 132
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline: ESRS Total Score 7.39  (13.2)
Week 13: ESRS Total Score 2.21  (4.6)
Baseline: Park, Dyst, Dysk and Akat 1.86  (2.6)
Week 13: Park, Dyst, Dysk and Akat 0.56  (1.1)
Baseline: Park 4.30  (7.3)
Week 13: Park 1.33  (2.8)
Baseline: Dyst 0.66  (3.4)
Week 13: Dyst 0.15  (1.0)
Baseline: Dysk Movements 0.58  (1.7)
Week 13: Dysk Movements 0.18  (0.5)
Baseline: Hyperkinesia 1.43  (3.4)
Week 13: Hyperkinesia 0.44  (1.3)
Baseline: Hypokinesia 2.66  (4.4)
Week 13: Hypokinesia 0.80  (1.6)
Baseline: Bucco-Linguo-Masticatory 0.21  (0.7)
Week 13: Bucco-Linguo-Masticatory 0.05  (0.25)
Baseline: Choreoathetoid movements of limbs 0.20  (0.6)
Week 13: Choreoathetoid movements of limbs 0.06  (0.3)
Time Frame Baseline up to end of study (Week 13)
Adverse Event Reporting Description Safety population included all participants who receive at least one dose of study medication (n=132).
 
Arm/Group Title Paliperidone ER
Hide Arm/Group Description Participants were administered paliperidone extended release (ER) tablets orally (taken by mouth; to be swallowed) once daily in the dose range of 3 to 12 milligram (mg) for 13 weeks. Dose was increased or decreased as per Investigator's discretion.
All-Cause Mortality
Paliperidone ER
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Paliperidone ER
Affected / at Risk (%)
Total   1/132 (0.76%) 
Nervous system disorders   
Worsening of Schizophrenia * 1  1/132 (0.76%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA/ V10.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Paliperidone ER
Affected / at Risk (%)
Total   21/132 (15.91%) 
Cardiac disorders   
Hypopiesia * 1  1/132 (0.76%) 
Increased Blood Pressure * 1  1/132 (0.76%) 
Tachicardia * 1  1/132 (0.76%) 
Endocrine disorders   
Galactorrhoea * 1  1/132 (0.76%) 
Hyperthyroidism * 1  1/132 (0.76%) 
Metabolism and nutrition disorders   
Weight Increase * 1  4/132 (3.03%) 
Nervous system disorders   
Agitation * 1  1/132 (0.76%) 
Insomnia * 1  4/132 (3.03%) 
Akatisia * 1  1/132 (0.76%) 
Anxiety * 1  1/132 (0.76%) 
Extrapyramidal Symptoms * 1  3/132 (2.27%) 
Increased Anxiety * 1  1/132 (0.76%) 
Increased Irritability * 1  1/132 (0.76%) 
Jaw Movements * 1  1/132 (0.76%) 
Lingual Movements * 1  1/132 (0.76%) 
Lower Limbs Tremor * 1  1/132 (0.76%) 
Psychomotor Agitation * 1  1/132 (0.76%) 
Ptyalism * 1  1/132 (0.76%) 
Slowness (Increased) * 1  1/132 (0.76%) 
Worsening of Anxiety * 1  1/132 (0.76%) 
Worsening of Bradikinesia * 1  1/132 (0.76%) 
Worsening of Tremor * 1  1/132 (0.76%) 
Skin and subcutaneous tissue disorders   
Rash (Mycosis) * 1  1/132 (0.76%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA/ V10.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Therapeutic Area Medical Manager
Organization: Janssen-Cilag SpA, Cologno Monzese, Milan - Italy
Phone: +39 0225101
Responsible Party: Janssen-Cilag S.p.A.
ClinicalTrials.gov Identifier: NCT01362439     History of Changes
Other Study ID Numbers: CR017578
R076477SCH3037
2008-002384-13
First Submitted: May 26, 2011
First Posted: May 30, 2011
Results First Submitted: February 14, 2013
Results First Posted: June 5, 2013
Last Update Posted: June 5, 2013