Trial Outcomes & Findings for A Trial to Explore the Tolerability, Safety and Efficacy of Paliperidone Extended Release in Patients With Schizophrenia (NCT NCT01606228)
NCT ID: NCT01606228
Last Updated: 2012-10-22
Results Overview
The PANSS is a 30-item scale (range 30-210) 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.
COMPLETED
PHASE3
188 participants
Baseline, Day 90
2012-10-22
Participant Flow
There were 188 patients enrolled in the study which were included in the safety analysis set. The main analysis set included only 176 subjects due to 12 protocol violations. Of these 176 patients, only 73 were included in the per-protocol analysis set. For the Clinical Global Impression-Severity scores, data was collected for only 60 patients.
Participant milestones
| Measure |
Paliperidone Extended-release (ER)
Paliperidone ER 6 mg orally administered once daily for the first five days. Thereafter, flexible dosing in a range of 3 to 12 mg/day.
|
|---|---|
|
Overall Study
STARTED
|
188
|
|
Overall Study
COMPLETED
|
159
|
|
Overall Study
NOT COMPLETED
|
29
|
Reasons for withdrawal
| Measure |
Paliperidone Extended-release (ER)
Paliperidone ER 6 mg orally administered once daily for the first five days. Thereafter, flexible dosing in a range of 3 to 12 mg/day.
|
|---|---|
|
Overall Study
Lost to Follow-up
|
20
|
|
Overall Study
Withdrawal by Subject
|
3
|
|
Overall Study
Non-compliant
|
3
|
|
Overall Study
Lack of Efficacy
|
2
|
|
Overall Study
Adverse Event
|
1
|
Baseline Characteristics
A Trial to Explore the Tolerability, Safety and Efficacy of Paliperidone Extended Release in Patients With Schizophrenia
Baseline characteristics by cohort
| Measure |
Paliperidone Extended-release (ER)
n=176 Participants
Paliperidone ER 6 mg orally administered once daily for the first five days. Thereafter, flexible dosing in a range of 3 to 12 mg/day.
|
|---|---|
|
Age Continuous
|
33.71 years
STANDARD_DEVIATION 9.743 • n=5 Participants
|
|
Sex: Female, Male
Female
|
70 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
106 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Day 90Population: Per Protocol (PP) population
The PANSS is a 30-item scale (range 30-210) 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.
Outcome measures
| Measure |
Paliperidone Extended-release (ER)
n=73 Participants
Paliperidone ER 6 mg orally administered once daily for the first five days. Thereafter, flexible dosing in a range of 3 to 12 mg/day.
|
|---|---|
|
The Proportion of Patients Improving 20% in Total Positive and Negative Syndrome Scale (PANSS) at Endpoint (Day 90)
|
97.73 percentage of patients
|
SECONDARY outcome
Timeframe: BaselinePopulation: Per Protocol (PP) population
The PANSS is a 30-item scale (range 30-210) 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.
Outcome measures
| Measure |
Paliperidone Extended-release (ER)
n=73 Participants
Paliperidone ER 6 mg orally administered once daily for the first five days. Thereafter, flexible dosing in a range of 3 to 12 mg/day.
|
|---|---|
|
Positive and Negative Syndrome Scale (PANSS) Scores at Baseline
|
108.25 scores on a scale
Standard Deviation 23.897
|
SECONDARY outcome
Timeframe: Day 90Population: Per Protocol (PP) population
The PANSS is a 30-item scale (range 30-210) 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.
Outcome measures
| Measure |
Paliperidone Extended-release (ER)
n=73 Participants
Paliperidone ER 6 mg orally administered once daily for the first five days. Thereafter, flexible dosing in a range of 3 to 12 mg/day.
|
|---|---|
|
Positive and Negative Syndrome Scale (PANSS) Scores at Day 90
|
48.74 scores on a scale
Standard Deviation 18.371
|
SECONDARY outcome
Timeframe: BaselinePopulation: Per Protocol (PP) population; participants for whom CGIS data was collected.
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 patient. The rating varies from "Normal (not at all ill)" to "Extreme (among the most extremely ill patients)".
Outcome measures
| Measure |
Paliperidone Extended-release (ER)
n=60 Participants
Paliperidone ER 6 mg orally administered once daily for the first five days. Thereafter, flexible dosing in a range of 3 to 12 mg/day.
|
|---|---|
|
Clinical Global Impression-Severity (CGIS) Scores at Baseline
Normal
|
0 participants
|
|
Clinical Global Impression-Severity (CGIS) Scores at Baseline
Borderline
|
0 participants
|
|
Clinical Global Impression-Severity (CGIS) Scores at Baseline
Mild
|
0 participants
|
|
Clinical Global Impression-Severity (CGIS) Scores at Baseline
Moderate
|
11 participants
|
|
Clinical Global Impression-Severity (CGIS) Scores at Baseline
Marked
|
33 participants
|
|
Clinical Global Impression-Severity (CGIS) Scores at Baseline
Severe
|
14 participants
|
|
Clinical Global Impression-Severity (CGIS) Scores at Baseline
Extreme
|
2 participants
|
SECONDARY outcome
Timeframe: Day 90Population: Per Protocol (PP) population
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 patient. The rating varies from "Normal (not at all ill)" to "Extreme (among the most extremely ill patients)".
Outcome measures
| Measure |
Paliperidone Extended-release (ER)
n=60 Participants
Paliperidone ER 6 mg orally administered once daily for the first five days. Thereafter, flexible dosing in a range of 3 to 12 mg/day.
|
|---|---|
|
Clinical Global Impression-Severity (CGIS) Scores at Day 90
Normal
|
0 participants
|
|
Clinical Global Impression-Severity (CGIS) Scores at Day 90
Borderline
|
31 participants
|
|
Clinical Global Impression-Severity (CGIS) Scores at Day 90
Mild
|
20 participants
|
|
Clinical Global Impression-Severity (CGIS) Scores at Day 90
Moderate
|
8 participants
|
|
Clinical Global Impression-Severity (CGIS) Scores at Day 90
Marked
|
1 participants
|
|
Clinical Global Impression-Severity (CGIS) Scores at Day 90
Severe
|
0 participants
|
|
Clinical Global Impression-Severity (CGIS) Scores at Day 90
Extreme
|
0 participants
|
SECONDARY outcome
Timeframe: BaselinePopulation: Per Protocol (PP) population
This PSP assesses the degree of a patient's 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 (i, absent to vi, very severe) in each of the 4 domains. Based on the four domains there will be one total score. Patients with a score 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.
Outcome measures
| Measure |
Paliperidone Extended-release (ER)
n=73 Participants
Paliperidone ER 6 mg orally administered once daily for the first five days. Thereafter, flexible dosing in a range of 3 to 12 mg/day.
|
|---|---|
|
Personal and Social Performance (PSP) Scores at Baseline
|
37.23 scores on a scale
Standard Deviation 12.675
|
SECONDARY outcome
Timeframe: Day 90Population: Per Protocol (PP) population
This PSP assesses the degree of a patient's 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 (i, absent to vi, very severe) in each of the 4 domains. Based on the four domains there will be one total score. Patients with a score 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.
Outcome measures
| Measure |
Paliperidone Extended-release (ER)
n=73 Participants
Paliperidone ER 6 mg orally administered once daily for the first five days. Thereafter, flexible dosing in a range of 3 to 12 mg/day.
|
|---|---|
|
Personal and Social Performance (PSP) Scores at Day 90
|
75.66 scores on a scale
Standard Deviation 10.451
|
SECONDARY outcome
Timeframe: 90 daysPopulation: Per Protocol (PP) population
Patients will be interviewed to assess their satisfaction with the current treatment on a 5-point scale (very good, good, reasonable, moderate or poor).
Outcome measures
| Measure |
Paliperidone Extended-release (ER)
n=73 Participants
Paliperidone ER 6 mg orally administered once daily for the first five days. Thereafter, flexible dosing in a range of 3 to 12 mg/day.
|
|---|---|
|
Patient Satisfaction With Paliperidone Treatment
Very good
|
33 participants
|
|
Patient Satisfaction With Paliperidone Treatment
Good
|
34 participants
|
|
Patient Satisfaction With Paliperidone Treatment
Moderate
|
4 participants
|
|
Patient Satisfaction With Paliperidone Treatment
Poor
|
1 participants
|
|
Patient Satisfaction With Paliperidone Treatment
Very poor
|
1 participants
|
SECONDARY outcome
Timeframe: BaselinePopulation: Per Protocol (PP) population
The quality of sleep is measured by a self-administered scale in which patients indicate how well they have slept in the previous 7 days, from 0 (very badly) to 100 (very well).
Outcome measures
| Measure |
Paliperidone Extended-release (ER)
n=73 Participants
Paliperidone ER 6 mg orally administered once daily for the first five days. Thereafter, flexible dosing in a range of 3 to 12 mg/day.
|
|---|---|
|
Quality of Sleep at Baseline
|
33.99 scores on a scale
Standard Deviation 30.091
|
SECONDARY outcome
Timeframe: Day 90Population: Per Protocol (PP) population
The quality of sleep is measured by a self-administered scale in which patients indicate how well they have slept in the previous 7 days, from 0 (very badly) to 100 (very well).
Outcome measures
| Measure |
Paliperidone Extended-release (ER)
n=73 Participants
Paliperidone ER 6 mg orally administered once daily for the first five days. Thereafter, flexible dosing in a range of 3 to 12 mg/day.
|
|---|---|
|
Quality of Sleep at Day 90
|
86.56 scores on a scale
Standard Deviation 18.684
|
SECONDARY outcome
Timeframe: BaselinePopulation: Per Protocol (PP) population
The daytime drowsiness is measured by a self-administered scale in which patients indicate how often they have felt drowsy within the previous 7 days, from 0 (not at all) to 100 (all the time).
Outcome measures
| Measure |
Paliperidone Extended-release (ER)
n=73 Participants
Paliperidone ER 6 mg orally administered once daily for the first five days. Thereafter, flexible dosing in a range of 3 to 12 mg/day.
|
|---|---|
|
Daytime Drowsiness at Baseline
|
21.49 scores on a scale
Standard Deviation 22.511
|
SECONDARY outcome
Timeframe: Day 90Population: Per Protocol (PP) population
The daytime drowsiness is measured by a self-administered scale in which patients indicate how often they have felt drowsy within the previous 7 days, from 0 (not at all) to 100 (all the time).
Outcome measures
| Measure |
Paliperidone Extended-release (ER)
n=73 Participants
Paliperidone ER 6 mg orally administered once daily for the first five days. Thereafter, flexible dosing in a range of 3 to 12 mg/day.
|
|---|---|
|
Daytime Drowsiness at Day 90
|
11.23 scores on a scale
Standard Deviation 19.061
|
Adverse Events
Paliperidone Extended-release (ER)
Serious adverse events
| Measure |
Paliperidone Extended-release (ER)
n=188 participants at risk
Paliperidone ER 6 mg orally administered once daily for the first five days. Thereafter, flexible dosing in a range of 3 to 12 mg/day.
|
|---|---|
|
Psychiatric disorders
Schizophrenia paranoid type
|
0.53%
1/188
|
|
Cardiac disorders
Arrhythmia
|
0.53%
1/188
|
|
Cardiac disorders
Ventricular Extrasystoles
|
0.53%
1/188
|
|
Nervous system disorders
Akathisia
|
0.53%
1/188
|
|
Psychiatric disorders
Schizophrenia
|
1.1%
2/188
|
Other adverse events
| Measure |
Paliperidone Extended-release (ER)
n=188 participants at risk
Paliperidone ER 6 mg orally administered once daily for the first five days. Thereafter, flexible dosing in a range of 3 to 12 mg/day.
|
|---|---|
|
Psychiatric disorders
Insomnia
|
13.3%
25/188
|
|
Metabolism and nutrition disorders
Anemia
|
4.8%
9/188
|
|
Vascular disorders
Hypertension
|
1.6%
3/188
|
|
General disorders
Pyrexia
|
1.6%
3/188
|
|
Nervous system disorders
Extra-Pyramidal Symptoms
|
1.6%
3/188
|
|
Nervous system disorders
Akathisia
|
1.6%
3/188
|
|
Psychiatric disorders
Acute psychotic symptoms
|
1.6%
3/188
|
|
Metabolism and nutrition disorders
Poor appetite
|
1.6%
3/188
|
|
Psychiatric disorders
Disturbed behavior
|
1.6%
3/188
|
|
Gastrointestinal disorders
Sialorrhea
|
1.6%
3/188
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.1%
2/188
|
|
Infections and infestations
Otitis media
|
1.1%
2/188
|
|
Nervous system disorders
Restlessness
|
1.1%
2/188
|
|
General disorders
Breast pain
|
1.1%
2/188
|
|
Infections and infestations
Urinary Tract Infection
|
1.1%
2/188
|
|
Social circumstances
Verbal assault
|
1.1%
2/188
|
|
Infections and infestations
Fungal infection
|
1.1%
2/188
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
1.1%
2/188
|
|
Nervous system disorders
Dizziness/Vertigo
|
0.53%
1/188
|
|
Nervous system disorders
Headache
|
0.53%
1/188
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.53%
1/188
|
|
Gastrointestinal disorders
Constipation
|
0.53%
1/188
|
|
Respiratory, thoracic and mediastinal disorders
Colds/nasal congestion
|
0.53%
1/188
|
|
Nervous system disorders
Tremors
|
0.53%
1/188
|
|
Nervous system disorders
Dystonia
|
0.53%
1/188
|
|
Skin and subcutaneous tissue disorders
Skin allergy
|
0.53%
1/188
|
|
Eye disorders
Upward gazing
|
0.53%
1/188
|
|
Vascular disorders
Orthostatic hypotension
|
0.53%
1/188
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.53%
1/188
|
|
Gastrointestinal disorders
Acute Gastroenteritis
|
0.53%
1/188
|
|
General disorders
Swelling of arm
|
0.53%
1/188
|
|
General disorders
Sore throat
|
0.53%
1/188
|
|
Skin and subcutaneous tissue disorders
Eczematous lesion
|
0.53%
1/188
|
|
Vascular disorders
External Hemorrhoid
|
0.53%
1/188
|
|
Infections and infestations
Pharyngitis
|
0.53%
1/188
|
|
Metabolism and nutrition disorders
Diabetes
|
0.53%
1/188
|
|
Musculoskeletal and connective tissue disorders
Sprain
|
0.53%
1/188
|
|
Infections and infestations
Scabies
|
0.53%
1/188
|
|
Psychiatric disorders
Manic-like behavior
|
0.53%
1/188
|
|
Psychiatric disorders
Delusions
|
0.53%
1/188
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.53%
1/188
|
|
Renal and urinary disorders
Renal Insufficiency
|
0.53%
1/188
|
|
Infections and infestations
Pulmonary Tuberculosis
|
0.53%
1/188
|
Additional Information
Medical Affairs Director, CNS, Asia Pacific
Janssen China
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place