Trial Outcomes & Findings for Evaluation of Effectiveness and Safety of Paliperidone Extended Release in Patients With Schizoaffective Disorder. (NCT NCT00397033)
NCT ID: NCT00397033
Last Updated: 2013-07-29
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
316 participants
Baseline
2013-07-29
Participant Flow
Participant milestones
| Measure |
Placebo
|
Paliperidone Extended Release (ER) Low Dose
Paliperidone Extended Release (ER) Low Dose - 6mg/day with option to reduce to 3mg/day
|
Paliperidone Extended Release (ER) High Dose
Paliperidone Extended Release (ER) High Dose - 12mg/day with option to reduce to 9mg/day
|
|---|---|---|---|
|
Overall Study
STARTED
|
107
|
109
|
100
|
|
Overall Study
Safety Population: >= 1 Dose of Drug
|
107
|
108
|
98
|
|
Overall Study
ITT Population
|
107
|
105
|
98
|
|
Overall Study
COMPLETED
|
63
|
72
|
77
|
|
Overall Study
NOT COMPLETED
|
44
|
37
|
23
|
Reasons for withdrawal
| Measure |
Placebo
|
Paliperidone Extended Release (ER) Low Dose
Paliperidone Extended Release (ER) Low Dose - 6mg/day with option to reduce to 3mg/day
|
Paliperidone Extended Release (ER) High Dose
Paliperidone Extended Release (ER) High Dose - 12mg/day with option to reduce to 9mg/day
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
7
|
10
|
4
|
|
Overall Study
Lack of Efficacy
|
22
|
12
|
9
|
|
Overall Study
Lost to Follow-up
|
3
|
3
|
3
|
|
Overall Study
Withdrawal by Subject
|
12
|
7
|
5
|
|
Overall Study
Other
|
0
|
5
|
2
|
Baseline Characteristics
Evaluation of Effectiveness and Safety of Paliperidone Extended Release in Patients With Schizoaffective Disorder.
Baseline characteristics by cohort
| Measure |
Placebo
n=107 Participants
|
Paliperidone Extended Release (ER) Low Dose
n=105 Participants
Paliperidone Extended Release (ER) Low Dose - 6mg/day with option to reduce to 3mg/day
|
Paliperidone Extended Release (ER) High Dose
n=98 Participants
Paliperidone Extended Release (ER) High Dose - 12mg/day with option to reduce to 9mg/day
|
Total
n=310 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age Continuous
|
37.1 years
STANDARD_DEVIATION 11.1 • n=93 Participants
|
38.1 years
STANDARD_DEVIATION 10.0 • n=4 Participants
|
36.5 years
STANDARD_DEVIATION 10.5 • n=27 Participants
|
37.3 years
STANDARD_DEVIATION 10.5 • n=483 Participants
|
|
Sex: Female, Male
Female
|
40 Participants
n=93 Participants
|
35 Participants
n=4 Participants
|
34 Participants
n=27 Participants
|
109 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
67 Participants
n=93 Participants
|
70 Participants
n=4 Participants
|
64 Participants
n=27 Participants
|
201 Participants
n=483 Participants
|
|
Region of Enrollment
United States
|
39 participants
n=93 Participants
|
39 participants
n=4 Participants
|
35 participants
n=27 Participants
|
113 participants
n=483 Participants
|
|
Region of Enrollment
India
|
33 participants
n=93 Participants
|
34 participants
n=4 Participants
|
31 participants
n=27 Participants
|
98 participants
n=483 Participants
|
|
Region of Enrollment
Russian Federation
|
12 participants
n=93 Participants
|
13 participants
n=4 Participants
|
11 participants
n=27 Participants
|
36 participants
n=483 Participants
|
|
Region of Enrollment
Ukraine
|
23 participants
n=93 Participants
|
19 participants
n=4 Participants
|
21 participants
n=27 Participants
|
63 participants
n=483 Participants
|
PRIMARY outcome
Timeframe: BaselinePopulation: The Intent-to-Treat population included all randomized participants who received at least 1 dose of study medication (or any portion of a dose) and had both baseline and at least 1 postbaseline PANSS assessment.
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 |
Placebo
n=107 Participants
|
Paliperidone Extended Release (ER) Low Dose
n=105 Participants
Paliperidone Extended Release (ER) Low Dose - 6mg/day with option to reduce to 3mg/day
|
Paliperidone Extended Release (ER) High Dose
n=98 Participants
Paliperidone Extended Release (ER) High Dose - 12mg/day with option to reduce to 9mg/day
|
|---|---|---|---|
|
Baseline Positive and Negative Symptoms of Schizophrenia (PANSS) Total Score
|
91.6 points on a scale
Standard Deviation 12.5
|
95.9 points on a scale
Standard Deviation 13.0
|
92.7 points on a scale
Standard Deviation 12.6
|
PRIMARY outcome
Timeframe: Baseline to Week 6 Last Observation Carried Forward (LOCF) End PointPopulation: Intent-to-Treat 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 |
Placebo
n=107 Participants
|
Paliperidone Extended Release (ER) Low Dose
n=105 Participants
Paliperidone Extended Release (ER) Low Dose - 6mg/day with option to reduce to 3mg/day
|
Paliperidone Extended Release (ER) High Dose
n=98 Participants
Paliperidone Extended Release (ER) High Dose - 12mg/day with option to reduce to 9mg/day
|
|---|---|---|---|
|
The Change From Baseline to Week 6 or the Last Post-randomization Assessment During Double-blind Treatment in the Positive and Negative Symptoms of Schizophrenia (PANSS) Total Score.
|
-21.7 points on scale
Standard Deviation 21.4
|
-27.4 points on scale
Standard Deviation 22.1
|
-30.6 points on scale
Standard Deviation 19.1
|
SECONDARY outcome
Timeframe: Baseline to Week 6 LOCF End PointPopulation: Intent-to-Treat population. One patient was not evaluable in the Paliperidone ER Low Dose treatment group.
Response is defined as a 30% or more reduction from baseline in PANSS total score and a CGI-C score of \<= 2. (CGI-C-SCA: Clinical Global Impression of Change for Schizoaffective Disorder). 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 CGI-S rating scale is a 7 point global assessment that measures the clinician's impression of the severity of illness exhibited by a subject.
Outcome measures
| Measure |
Placebo
n=107 Participants
|
Paliperidone Extended Release (ER) Low Dose
n=104 Participants
Paliperidone Extended Release (ER) Low Dose - 6mg/day with option to reduce to 3mg/day
|
Paliperidone Extended Release (ER) High Dose
n=98 Participants
Paliperidone Extended Release (ER) High Dose - 12mg/day with option to reduce to 9mg/day
|
|---|---|---|---|
|
Number of Participants With Response
|
40 count of participants
|
57 count of participants
|
62 count of participants
|
SECONDARY outcome
Timeframe: Baseline to Week 6 LOCF End PointPopulation: Intent-to-Treat population.
Positive Syndrome Scale (range 7-49): Sum of scores for items 1-7 in positive subscale: delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, and hostility. Higher scores indicate worsening.
Outcome measures
| Measure |
Placebo
n=107 Participants
|
Paliperidone Extended Release (ER) Low Dose
n=105 Participants
Paliperidone Extended Release (ER) Low Dose - 6mg/day with option to reduce to 3mg/day
|
Paliperidone Extended Release (ER) High Dose
n=98 Participants
Paliperidone Extended Release (ER) High Dose - 12mg/day with option to reduce to 9mg/day
|
|---|---|---|---|
|
Change in Positive and Negative Symptoms of Schizophrenia (PANSS) Positive Subscale Score
|
-7.9 points on subscale
Standard Deviation 6.6
|
-9.1 points on subscale
Standard Deviation 7.1
|
-11.3 points on subscale
Standard Deviation 6.3
|
SECONDARY outcome
Timeframe: Baseline to Week 6 LOCF End PointPopulation: Intent-to-Treat population
Negative Syndrome Scale (range 7-49): Sum of scores for items 1-7 in negative subscale: blunted effect, emotional withdrawal, poor rapport, passive apathetic social withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, and stereotyped thinking. Higher scores indicate worsening.
Outcome measures
| Measure |
Placebo
n=107 Participants
|
Paliperidone Extended Release (ER) Low Dose
n=105 Participants
Paliperidone Extended Release (ER) Low Dose - 6mg/day with option to reduce to 3mg/day
|
Paliperidone Extended Release (ER) High Dose
n=98 Participants
Paliperidone Extended Release (ER) High Dose - 12mg/day with option to reduce to 9mg/day
|
|---|---|---|---|
|
Change in Positive and Negative Symptoms of Schizophrenia (PANSS) Negative Subscale Score
|
-3.1 points on a subscale
Standard Deviation 5.1
|
-4.4 points on a subscale
Standard Deviation 5.6
|
-4.2 points on a subscale
Standard Deviation 5.1
|
SECONDARY outcome
Timeframe: Baseline to Week 6 LOCF End PointPopulation: Intent-to-Treat population
General Psychopathology (range 16-112): Sum of scores for somatic concern, anxiety, guilt feelings, tension, mannerisms/posturing, depression, motor retardation, uncooperativeness, unusual thought content, disoriented, poor attention, lack of judgment/insight, disturbance of volition, poor impulse control, preoccupation, and active social avoidance. Higher scores indicate worsening.
Outcome measures
| Measure |
Placebo
n=107 Participants
|
Paliperidone Extended Release (ER) Low Dose
n=105 Participants
Paliperidone Extended Release (ER) Low Dose - 6mg/day with option to reduce to 3mg/day
|
Paliperidone Extended Release (ER) High Dose
n=98 Participants
Paliperidone Extended Release (ER) High Dose - 12mg/day with option to reduce to 9mg/day
|
|---|---|---|---|
|
Change in Positive and Negative Symptoms of Schizophrenia (PANSS) General Psychopathology Subscale Score
|
-10.7 points on a subscale
Standard Deviation 11.6
|
-13.9 points on a subscale
Standard Deviation 12.0
|
-15.1 points on a subscale
Standard Deviation 10.3
|
SECONDARY outcome
Timeframe: Baseline to Week 6 LOCF End PointPopulation: Intent-to-Treat population.
Positive PANSS Factor Score (range 8-56): Sum of scores for items 1, 3, 5, and 6 in positive subscale: delusions, hallucinatory behavior, grandiosity, suspiciousness; item 7 in negative subscale: stereotyped thinking; and items 1, 9, and 12 in general psychopathology subscale: somatic concern, unusual thought content, lack of judgment, and insight. Higher scores indicate worsening.
Outcome measures
| Measure |
Placebo
n=107 Participants
|
Paliperidone Extended Release (ER) Low Dose
n=105 Participants
Paliperidone Extended Release (ER) Low Dose - 6mg/day with option to reduce to 3mg/day
|
Paliperidone Extended Release (ER) High Dose
n=98 Participants
Paliperidone Extended Release (ER) High Dose - 12mg/day with option to reduce to 9mg/day
|
|---|---|---|---|
|
Positive and Negative Symptoms of Schizophrenia (PANSS) Positive Factor Score
|
-6.7 points on a subscale
Standard Deviation 6.9
|
-8.0 points on a subscale
Standard Deviation 6.8
|
-9.6 points on a subscale
Standard Deviation 6.4
|
SECONDARY outcome
Timeframe: Baseline to Week 6 LOCF End PointPopulation: Intent-to-Treat population
Negative PANSS Factor Score (range 7-49): Sum of scores for items 1, 2, 3, 4, and 6 in negative subscale: blunted affect, emotional withdrawal, poor rapport, passive social withdrawal, lack of spontaneity; and items 7 and 16 in general psychopathology subscale: motor retardation, and active social avoidance. Higher scores indicate worsening.
Outcome measures
| Measure |
Placebo
n=107 Participants
|
Paliperidone Extended Release (ER) Low Dose
n=105 Participants
Paliperidone Extended Release (ER) Low Dose - 6mg/day with option to reduce to 3mg/day
|
Paliperidone Extended Release (ER) High Dose
n=98 Participants
Paliperidone Extended Release (ER) High Dose - 12mg/day with option to reduce to 9mg/day
|
|---|---|---|---|
|
Change in Positive and Negative Symptoms of Schizophrenia (PANSS) Negative Factor Score
|
-3.0 points on a subscale
Standard Deviation 5.0
|
-4.5 points on a subscale
Standard Deviation 5.7
|
-4.0 points on a subscale
Standard Deviation 5.1
|
SECONDARY outcome
Timeframe: Baseline to Week 6 LOCF End PointPopulation: Intent-to-Treat population
Disorganized Thoughts PANSS Factor Score (range 7-49): Sum of scores for item 2 in positive subscale:Conceptual disorganization; item 5 in negative subscale:difficulty in abstract thinking; and items 5, 10, 11, 13, and 15 in general psychopathology subscale: mannerisms/posturing, disorientation, poor attention, disturbance of volition, and preoccupation. Higher scores indicate worsening.
Outcome measures
| Measure |
Placebo
n=107 Participants
|
Paliperidone Extended Release (ER) Low Dose
n=105 Participants
Paliperidone Extended Release (ER) Low Dose - 6mg/day with option to reduce to 3mg/day
|
Paliperidone Extended Release (ER) High Dose
n=98 Participants
Paliperidone Extended Release (ER) High Dose - 12mg/day with option to reduce to 9mg/day
|
|---|---|---|---|
|
Change in Positive and Negative Symptoms of Schizophrenia (PANSS) Disorganized Thought Factor Score
|
-3.7 points on a subscale
Standard Deviation 5.2
|
-5.0 points on a subscale
Standard Deviation 5.0
|
-5.7 points on a subscale
Standard Deviation 4.8
|
SECONDARY outcome
Timeframe: Baseline to Week 6 LOCF End PointPopulation: Intent-to-Treat population
Uncontrolled Hostility/Excitement PANSS Factor Score (range 4-28): Sum of scores for items 4 and 7 in positive subscale: excitement, hostility; and items 8 and 14 in general psychopathology subscale: uncooperativeness, and poor impulse control. Higher scores indicate worsening.
Outcome measures
| Measure |
Placebo
n=107 Participants
|
Paliperidone Extended Release (ER) Low Dose
n=105 Participants
Paliperidone Extended Release (ER) Low Dose - 6mg/day with option to reduce to 3mg/day
|
Paliperidone Extended Release (ER) High Dose
n=98 Participants
Paliperidone Extended Release (ER) High Dose - 12mg/day with option to reduce to 9mg/day
|
|---|---|---|---|
|
Change in Positive and Negative Symptoms of Schizophrenia (PANSS) Uncontrolled Hostility/Excitement Factor Score
|
-4.8 points on a subscale
Standard Deviation 4.4
|
-5.4 points on a subscale
Standard Deviation 4.8
|
-7.0 points on a subscale
Standard Deviation 4.2
|
SECONDARY outcome
Timeframe: Baseline to Week 6 LOCF End PointPopulation: Intent-to-Treat population
Anxiety/Depression PANSS Factor Score (range 4-28): Sum of scores for items 2, 3, 4, and 6 in general psychopathology subscale: Anxiety, Guilt feelings, Tension, Depression. Higher scores indicate worsening.
Outcome measures
| Measure |
Placebo
n=107 Participants
|
Paliperidone Extended Release (ER) Low Dose
n=105 Participants
Paliperidone Extended Release (ER) Low Dose - 6mg/day with option to reduce to 3mg/day
|
Paliperidone Extended Release (ER) High Dose
n=98 Participants
Paliperidone Extended Release (ER) High Dose - 12mg/day with option to reduce to 9mg/day
|
|---|---|---|---|
|
Change in Positive and Negative Symptoms of Schizophrenia (PANSS) Anxiety/Depression Factor Score
|
-3.4 points on a subscale
Standard Deviation 4.0
|
-4.5 points on a subscale
Standard Deviation 3.8
|
-4.3 points on a subscale
Standard Deviation 3.7
|
SECONDARY outcome
Timeframe: BaselinePopulation: Intent-to-Treat 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 subject. 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 subjects".
Outcome measures
| Measure |
Placebo
n=107 Participants
|
Paliperidone Extended Release (ER) Low Dose
n=105 Participants
Paliperidone Extended Release (ER) Low Dose - 6mg/day with option to reduce to 3mg/day
|
Paliperidone Extended Release (ER) High Dose
n=98 Participants
Paliperidone Extended Release (ER) High Dose - 12mg/day with option to reduce to 9mg/day
|
|---|---|---|---|
|
Clinical Global Impression (CGI-S) - Severity for Schizoaffective Disorder Score at Baseline
|
4.6 points on a scale
Standard Deviation 0.6
|
4.6 points on a scale
Standard Deviation 0.6
|
4.6 points on a scale
Standard Deviation 0.6
|
SECONDARY outcome
Timeframe: Baseline to Week 6 LOCF End PointPopulation: Intent-to-Treat population. One patient was not evaluable in the Paliperidone ER Low Dose treatment group.
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 subject. 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 subjects".
Outcome measures
| Measure |
Placebo
n=107 Participants
|
Paliperidone Extended Release (ER) Low Dose
n=104 Participants
Paliperidone Extended Release (ER) Low Dose - 6mg/day with option to reduce to 3mg/day
|
Paliperidone Extended Release (ER) High Dose
n=98 Participants
Paliperidone Extended Release (ER) High Dose - 12mg/day with option to reduce to 9mg/day
|
|---|---|---|---|
|
Change in Clinical Global Impression (CGI-S) - Severity for Schizoaffective Disorder
|
-1.1 points on scale
Standard Deviation 1.3
|
-1.4 points on scale
Standard Deviation 1.2
|
-1.8 points on scale
Standard Deviation 1.0
|
SECONDARY outcome
Timeframe: Week 6 LOCF End PointPopulation: Intent-to-Treat population. One patient was not evaluable in the Paliperidone ER Low Dose treatment group.
The CGI-C rating scale is a 7 point global assessment that measures the clinician's impression of the change occurring in the illness over a course of treatment, relative to baseline. A rating of 4 is equivalent to "No change". Ratings of \<4 are equivalent to "improvement" and ratings of \> 4 are equivalent to "worsening".
Outcome measures
| Measure |
Placebo
n=107 Participants
|
Paliperidone Extended Release (ER) Low Dose
n=104 Participants
Paliperidone Extended Release (ER) Low Dose - 6mg/day with option to reduce to 3mg/day
|
Paliperidone Extended Release (ER) High Dose
n=98 Participants
Paliperidone Extended Release (ER) High Dose - 12mg/day with option to reduce to 9mg/day
|
|---|---|---|---|
|
Clinical Global Impression (CGI-C) - Change for Schizoaffective Disorder
|
2.9 points on a scale
Standard Deviation 1.4
|
2.6 points on a scale
Standard Deviation 1.3
|
2.2 points on a scale
Standard Deviation 1.1
|
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselinePopulation: Intent-to-Treat population with a baseline HAM-D-21 total score of \>= 16.
Clinician-rated scale that evaluates depressed mood as well as the vegetative and cognitive symptoms of depression. The items are rated on either a 5-point (0 to 4) or a 3-point (0 to 2) scale. The 5-point scale uses a rating of 0 (absent), 1 (doubtful to mild), 2 (mild to moderate), 3 (moderate to severe), and 4 (very severe). Higher scores indicate worsening. The responses are summed to yield the HAM-D-21 score that ranges from 0-63.
Outcome measures
| Measure |
Placebo
n=64 Participants
|
Paliperidone Extended Release (ER) Low Dose
n=76 Participants
Paliperidone Extended Release (ER) Low Dose - 6mg/day with option to reduce to 3mg/day
|
Paliperidone Extended Release (ER) High Dose
n=61 Participants
Paliperidone Extended Release (ER) High Dose - 12mg/day with option to reduce to 9mg/day
|
|---|---|---|---|
|
Hamilton Rating Scale for Depression (HAM-D-21) With Baseline HAM-D-21 Total Score >= 16
|
24.4 points on a scale
Standard Deviation 5.9
|
25.2 points on a scale
Standard Deviation 6.8
|
26.9 points on a scale
Standard Deviation 7.3
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to Week 6 LOCF End PointPopulation: Intent-to-Treat population with a baseline HAM-D-21 total score of \>= 16.
Clinician-rated scale that evaluates depressed mood as well as the vegetative and cognitive symptoms of depression. The items are rated on either a 5-point (0 to 4) or a 3-point (0 to 2) scale. The 5-point scale uses a rating of 0 (absent), 1 (doubtful to mild), 2 (mild to moderate), 3 (moderate to severe), and 4 (very severe). Higher scores indicate worsening. The responses are summed to yield the HAM-D-21 score that ranges from 0-63.
Outcome measures
| Measure |
Placebo
n=64 Participants
|
Paliperidone Extended Release (ER) Low Dose
n=75 Participants
Paliperidone Extended Release (ER) Low Dose - 6mg/day with option to reduce to 3mg/day
|
Paliperidone Extended Release (ER) High Dose
n=61 Participants
Paliperidone Extended Release (ER) High Dose - 12mg/day with option to reduce to 9mg/day
|
|---|---|---|---|
|
Change in Hamilton Rating Scale for Depression (HAM-D-21) With Baseline HAM-D-21 Total Score >= 16
|
-9.9 points on scale
Standard Deviation 10.7
|
-13.6 points on scale
Standard Deviation 9.2
|
-14.5 points on scale
Standard Deviation 9.2
|
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselinePopulation: Intent-to-Treat population with a baseline YMRS total score of \>= 16.
11-item scale (elevated mood, increased motor activity, sexual interest, sleep, irritability, speech \[rate/amount\], language-thought disorder, content, disruptive-aggressive behaviors, appearance, and insight) based on subject's report of his or her condition and clinician's behavioral observations during the interview, with emphasis on the latter. Higher scores indicate worsening. The responses are summed to yield the YMRS total score, which ranges from 0 to 60.
Outcome measures
| Measure |
Placebo
n=90 Participants
|
Paliperidone Extended Release (ER) Low Dose
n=88 Participants
Paliperidone Extended Release (ER) Low Dose - 6mg/day with option to reduce to 3mg/day
|
Paliperidone Extended Release (ER) High Dose
n=79 Participants
Paliperidone Extended Release (ER) High Dose - 12mg/day with option to reduce to 9mg/day
|
|---|---|---|---|
|
Young Mania Rating Scale (YMRS) With Baseline YMRS Total Score >= 16
|
28.5 points on a scale
Standard Deviation 6.9
|
28.4 points on a scale
Standard Deviation 7.4
|
29.9 points on a scale
Standard Deviation 8.2
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to Week 6 LOCF End PointPopulation: Intent-to-Treat population with a baseline YMRS total score of \>= 16.
11-item scale (elevated mood, increased motor activity, sexual interest, sleep, irritability, speech \[rate/amount\], language-thought disorder, content, disruptive-aggressive behaviors, appearance, and insight) based on subject's report of his or her condition and clinician's behavioral observations during the interview, with emphasis on the latter. Higher scores indicate worsening. The responses are summed to yield the YMRS total score, which ranges from 0 to 60.
Outcome measures
| Measure |
Placebo
n=90 Participants
|
Paliperidone Extended Release (ER) Low Dose
n=87 Participants
Paliperidone Extended Release (ER) Low Dose - 6mg/day with option to reduce to 3mg/day
|
Paliperidone Extended Release (ER) High Dose
n=79 Participants
Paliperidone Extended Release (ER) High Dose - 12mg/day with option to reduce to 9mg/day
|
|---|---|---|---|
|
Change in Young Mania Rating Scale (YMRS) With Baseline YMRS Total Score >= 16
|
-11.5 points on scale
Standard Deviation 11.4
|
-14.3 points on scale
Standard Deviation 11.8
|
-19.4 points on scale
Standard Deviation 11.7
|
Adverse Events
Placebo
Paliperidone Extended Release (ER) Low Dose
Paliperidone Extended Release (ER) High Dose
Serious adverse events
| Measure |
Placebo
n=107 participants at risk
|
Paliperidone Extended Release (ER) Low Dose
n=108 participants at risk
Paliperidone Extended Release (ER) Low Dose - 6mg/day with option to reduce to 3mg/day
|
Paliperidone Extended Release (ER) High Dose
n=98 participants at risk
Paliperidone Extended Release (ER) High Dose - 12mg/day with option to reduce to 9mg/day
|
|---|---|---|---|
|
Cardiac disorders
Supraventricular tachycardia
|
0.93%
1/107
Safety Population
|
0.00%
0/108
Safety Population
|
0.00%
0/98
Safety Population
|
|
Infections and infestations
Salpingitis
|
0.00%
0/107
Safety Population
|
0.93%
1/108
Safety Population
|
0.00%
0/98
Safety Population
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/107
Safety Population
|
0.93%
1/108
Safety Population
|
0.00%
0/98
Safety Population
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.00%
0/107
Safety Population
|
0.00%
0/108
Safety Population
|
1.0%
1/98
Safety Population
|
|
Nervous system disorders
Grand mal convulsion
|
0.00%
0/107
Safety Population
|
0.93%
1/108
Safety Population
|
0.00%
0/98
Safety Population
|
|
Psychiatric disorders
Depressed mood
|
0.93%
1/107
Safety Population
|
0.93%
1/108
Safety Population
|
0.00%
0/98
Safety Population
|
|
Psychiatric disorders
Depression
|
0.00%
0/107
Safety Population
|
0.00%
0/108
Safety Population
|
1.0%
1/98
Safety Population
|
|
Psychiatric disorders
Psychotic disorder
|
0.93%
1/107
Safety Population
|
1.9%
2/108
Safety Population
|
0.00%
0/98
Safety Population
|
|
Psychiatric disorders
Schizoaffective disorder
|
1.9%
2/107
Safety Population
|
3.7%
4/108
Safety Population
|
0.00%
0/98
Safety Population
|
|
Psychiatric disorders
Suicidal behavior
|
0.00%
0/107
Safety Population
|
0.93%
1/108
Safety Population
|
0.00%
0/98
Safety Population
|
|
Psychiatric disorders
Suicidal ideation
|
0.93%
1/107
Safety Population
|
0.00%
0/108
Safety Population
|
0.00%
0/98
Safety Population
|
|
Reproductive system and breast disorders
Metrorrhagia
|
0.00%
0/107
Safety Population
|
0.00%
0/108
Safety Population
|
1.0%
1/98
Safety Population
|
Other adverse events
| Measure |
Placebo
n=107 participants at risk
|
Paliperidone Extended Release (ER) Low Dose
n=108 participants at risk
Paliperidone Extended Release (ER) Low Dose - 6mg/day with option to reduce to 3mg/day
|
Paliperidone Extended Release (ER) High Dose
n=98 participants at risk
Paliperidone Extended Release (ER) High Dose - 12mg/day with option to reduce to 9mg/day
|
|---|---|---|---|
|
Gastrointestinal disorders
Constipation
|
1.9%
2/107 • Number of events 2
Safety Population
|
3.7%
4/108 • Number of events 4
Safety Population
|
5.1%
5/98 • Number of events 8
Safety Population
|
|
Gastrointestinal disorders
Dry Mouth
|
3.7%
4/107 • Number of events 4
Safety Population
|
6.5%
7/108 • Number of events 8
Safety Population
|
2.0%
2/98 • Number of events 2
Safety Population
|
|
Gastrointestinal disorders
Nausea
|
7.5%
8/107 • Number of events 9
Safety Population
|
8.3%
9/108 • Number of events 11
Safety Population
|
8.2%
8/98 • Number of events 14
Safety Population
|
|
Infections and infestations
Nasopharyngitis
|
1.9%
2/107 • Number of events 2
Safety Population
|
1.9%
2/108 • Number of events 2
Safety Population
|
5.1%
5/98 • Number of events 5
Safety Population
|
|
Nervous system disorders
Akathisia
|
7.5%
8/107 • Number of events 9
Safety Population
|
3.7%
4/108 • Number of events 4
Safety Population
|
6.1%
6/98 • Number of events 7
Safety Population
|
|
Nervous system disorders
Dizziness
|
6.5%
7/107 • Number of events 7
Safety Population
|
5.6%
6/108 • Number of events 7
Safety Population
|
4.1%
4/98 • Number of events 4
Safety Population
|
|
Nervous system disorders
Headache
|
16.8%
18/107 • Number of events 22
Safety Population
|
13.9%
15/108 • Number of events 16
Safety Population
|
13.3%
13/98 • Number of events 18
Safety Population
|
|
Nervous system disorders
Hypertonia
|
2.8%
3/107 • Number of events 3
Safety Population
|
8.3%
9/108 • Number of events 10
Safety Population
|
4.1%
4/98 • Number of events 5
Safety Population
|
|
Nervous system disorders
Sedation
|
4.7%
5/107 • Number of events 6
Safety Population
|
7.4%
8/108 • Number of events 9
Safety Population
|
4.1%
4/98 • Number of events 5
Safety Population
|
|
Nervous system disorders
Somnolence
|
1.9%
2/107 • Number of events 2
Safety Population
|
4.6%
5/108 • Number of events 5
Safety Population
|
8.2%
8/98 • Number of events 8
Safety Population
|
|
Nervous system disorders
Tremor
|
3.7%
4/107 • Number of events 6
Safety Population
|
12.0%
13/108 • Number of events 13
Safety Population
|
11.2%
11/98 • Number of events 12
Safety Population
|
|
Psychiatric disorders
Agitation
|
5.6%
6/107 • Number of events 6
Safety Population
|
6.5%
7/108 • Number of events 7
Safety Population
|
1.0%
1/98 • Number of events 2
Safety Population
|
|
Psychiatric disorders
Insomnia
|
8.4%
9/107 • Number of events 11
Safety Population
|
4.6%
5/108 • Number of events 6
Safety Population
|
9.2%
9/98 • Number of events 10
Safety Population
|
|
Psychiatric disorders
Schizoaffective Disorder
|
2.8%
3/107 • Number of events 4
Safety Population
|
5.6%
6/108 • Number of events 6
Safety Population
|
0.00%
0/98
Safety Population
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/107
Safety Population
|
4.6%
5/108 • Number of events 6
Safety Population
|
6.1%
6/98 • Number of events 6
Safety Population
|
Additional Information
Vice President, Medical Affairs, CNS
Ortho McNeil Janssen Scientific Affairs, LLC
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60