Trial Outcomes & Findings for A Study to Evaluate the Effectiveness and Safety of Extended-Release (ER) Paliperidone Compared With Placebo in Delaying the Recurrence of Symptoms in Bipolar I Disorder (NCT NCT00490971)
NCT ID: NCT00490971
Last Updated: 2015-04-15
Results Overview
Time to first recurrence of any mood symptoms (ie, manic or depressive) associated with bipolar I disorder during the maintenance phase, after maintaining clinical stability during continued treatment with paliperidone ER over a period of 15 weeks. The time period was from occurrence of acute manic or mixed episode to Week 15. This outcome was measured using combination of various scales, hospitalization for any mood symptoms, use of any medicines for an mood episode and clinical events suggestive of recurrent mood episode associated with bipolar I disorder.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
768 participants
Primary outcome timeframe
Date of randomization into the maintenance phase until the first occurrence of recurrence of any symptoms or discontinuation from the study, assessed over a period of 41 months.
Results posted on
2015-04-15
Participant Flow
The double-blind (ie, niether physician nor patient knows the treatment that the patient receives) study has 15-week acute/continuation phase followed by variable-duration maintenance phase (lasting until patient had recurrence or discontinued treatment) to assess effect of paliperidone on maintenance of remission of Bipolar I Disorder
Participant milestones
| Measure |
Paliperidone Extented Release (ER)
Acute and continuation period. Paliperidone ER: Oral tablet, 3 mg/day to 12 mg/day, Once daily.
|
Olanzapine
Acute and continuation period. Olanzapine: Oral tablet, 5 mg/day to 20 mg/day, Once daily.
|
Pali/Placebo
Maintenance period. Placebo (Paliperidone in the acute and continuation period).
|
Pali/Pali
Maintenance period. Paliperidone ER: Oral tablet, 3 mg/day to 12 mg/day, Once daily (Paliperidone in the acute and continuation period)
|
Olan/Olan
Maintenance period. Olanzapine Oral tablet, 5 mg/day to 20 mg/day, Once daily (Olanzapine in the acute and continuation period)
|
|---|---|---|---|---|---|
|
Acute/Continuation
STARTED
|
614
|
148
|
0
|
0
|
0
|
|
Acute/Continuation
COMPLETED
|
308
|
86
|
0
|
0
|
0
|
|
Acute/Continuation
NOT COMPLETED
|
306
|
62
|
0
|
0
|
0
|
|
Maintenance
STARTED
|
0
|
0
|
147
|
149
|
83
|
|
Maintenance
COMPLETED
|
0
|
0
|
96
|
96
|
44
|
|
Maintenance
NOT COMPLETED
|
0
|
0
|
51
|
53
|
39
|
Reasons for withdrawal
| Measure |
Paliperidone Extented Release (ER)
Acute and continuation period. Paliperidone ER: Oral tablet, 3 mg/day to 12 mg/day, Once daily.
|
Olanzapine
Acute and continuation period. Olanzapine: Oral tablet, 5 mg/day to 20 mg/day, Once daily.
|
Pali/Placebo
Maintenance period. Placebo (Paliperidone in the acute and continuation period).
|
Pali/Pali
Maintenance period. Paliperidone ER: Oral tablet, 3 mg/day to 12 mg/day, Once daily (Paliperidone in the acute and continuation period)
|
Olan/Olan
Maintenance period. Olanzapine Oral tablet, 5 mg/day to 20 mg/day, Once daily (Olanzapine in the acute and continuation period)
|
|---|---|---|---|---|---|
|
Acute/Continuation
Adverse Event
|
62
|
13
|
0
|
0
|
0
|
|
Acute/Continuation
Death
|
2
|
0
|
0
|
0
|
0
|
|
Acute/Continuation
Lack of Efficacy
|
106
|
12
|
0
|
0
|
0
|
|
Acute/Continuation
Lost to Follow-up
|
23
|
7
|
0
|
0
|
0
|
|
Acute/Continuation
Protocol Violation
|
10
|
2
|
0
|
0
|
0
|
|
Acute/Continuation
Withdrawal by Subject
|
92
|
24
|
0
|
0
|
0
|
|
Acute/Continuation
Other
|
11
|
4
|
0
|
0
|
0
|
|
Maintenance
Adverse Event
|
0
|
0
|
4
|
5
|
7
|
|
Maintenance
Death
|
0
|
0
|
0
|
2
|
0
|
|
Maintenance
Lost to Follow-up
|
0
|
0
|
5
|
8
|
10
|
|
Maintenance
Pregnancy
|
0
|
0
|
1
|
0
|
0
|
|
Maintenance
Protocol Violation
|
0
|
0
|
4
|
1
|
1
|
|
Maintenance
Withdrawal by Subject
|
0
|
0
|
26
|
28
|
18
|
|
Maintenance
Other
|
0
|
0
|
11
|
9
|
3
|
Baseline Characteristics
A Study to Evaluate the Effectiveness and Safety of Extended-Release (ER) Paliperidone Compared With Placebo in Delaying the Recurrence of Symptoms in Bipolar I Disorder
Baseline characteristics by cohort
| Measure |
Paliperidone ER
n=614 Participants
Acute and continuation period. Paliperidone ER: Oral tablet, 3 mg/day to 12 mg/day, Once daily.
|
Olanzapine
n=148 Participants
Acute and continuation period. Olanzapine: Oral tablet, 5 mg/day to 20 mg/day, Once daily.
|
Total
n=762 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
7 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
606 Participants
n=5 Participants
|
145 Participants
n=7 Participants
|
751 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Age, Continuous
|
39.7 years
STANDARD_DEVIATION 11.93 • n=5 Participants
|
39.2 years
STANDARD_DEVIATION 11.49 • n=7 Participants
|
39.6 years
STANDARD_DEVIATION 11.84 • n=5 Participants
|
|
Sex: Female, Male
Female
|
310 Participants
n=5 Participants
|
80 Participants
n=7 Participants
|
390 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
304 Participants
n=5 Participants
|
68 Participants
n=7 Participants
|
372 Participants
n=5 Participants
|
|
Region of Enrollment
Asia
|
162 participants
n=5 Participants
|
36 participants
n=7 Participants
|
198 participants
n=5 Participants
|
|
Region of Enrollment
Eastern Europe
|
129 participants
n=5 Participants
|
31 participants
n=7 Participants
|
160 participants
n=5 Participants
|
|
Region of Enrollment
European Union
|
71 participants
n=5 Participants
|
19 participants
n=7 Participants
|
90 participants
n=5 Participants
|
|
Region of Enrollment
North America
|
177 participants
n=5 Participants
|
41 participants
n=7 Participants
|
218 participants
n=5 Participants
|
|
Region of Enrollment
Other
|
75 participants
n=5 Participants
|
21 participants
n=7 Participants
|
96 participants
n=5 Participants
|
|
Region of Enrollment
India
|
69 participants
n=5 Participants
|
14 participants
n=7 Participants
|
83 participants
n=5 Participants
|
|
Region of Enrollment
Malaysia
|
7 participants
n=5 Participants
|
2 participants
n=7 Participants
|
9 participants
n=5 Participants
|
|
Region of Enrollment
China
|
86 participants
n=5 Participants
|
20 participants
n=7 Participants
|
106 participants
n=5 Participants
|
|
Region of Enrollment
Russian Federation
|
51 participants
n=5 Participants
|
11 participants
n=7 Participants
|
62 participants
n=5 Participants
|
|
Region of Enrollment
Serbia
|
32 participants
n=5 Participants
|
8 participants
n=7 Participants
|
40 participants
n=5 Participants
|
|
Region of Enrollment
Ukraine
|
46 participants
n=5 Participants
|
12 participants
n=7 Participants
|
58 participants
n=5 Participants
|
|
Region of Enrollment
Bulgaria
|
27 participants
n=5 Participants
|
6 participants
n=7 Participants
|
33 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
6 participants
n=5 Participants
|
3 participants
n=7 Participants
|
9 participants
n=5 Participants
|
|
Region of Enrollment
Poland
|
16 participants
n=5 Participants
|
5 participants
n=7 Participants
|
21 participants
n=5 Participants
|
|
Region of Enrollment
Romania
|
22 participants
n=5 Participants
|
5 participants
n=7 Participants
|
27 participants
n=5 Participants
|
|
Region of Enrollment
Costa Rica
|
12 participants
n=5 Participants
|
4 participants
n=7 Participants
|
16 participants
n=5 Participants
|
|
Region of Enrollment
Morocco
|
6 participants
n=5 Participants
|
2 participants
n=7 Participants
|
8 participants
n=5 Participants
|
|
Region of Enrollment
Panama
|
3 participants
n=5 Participants
|
1 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Region of Enrollment
South Africa
|
26 participants
n=5 Participants
|
6 participants
n=7 Participants
|
32 participants
n=5 Participants
|
|
Region of Enrollment
Tunisia
|
10 participants
n=5 Participants
|
4 participants
n=7 Participants
|
14 participants
n=5 Participants
|
|
Region of Enrollment
Turkey
|
18 participants
n=5 Participants
|
4 participants
n=7 Participants
|
22 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
177 participants
n=5 Participants
|
41 participants
n=7 Participants
|
218 participants
n=5 Participants
|
|
AgeCategorical
18-25
|
98 participants
n=5 Participants
|
25 participants
n=7 Participants
|
123 participants
n=5 Participants
|
|
AgeCategorical
26-50
|
378 participants
n=5 Participants
|
96 participants
n=7 Participants
|
474 participants
n=5 Participants
|
|
AgeCategorical
51-65
|
138 participants
n=5 Participants
|
27 participants
n=7 Participants
|
165 participants
n=5 Participants
|
|
AgeCategorical
>65
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
AgeCategorical
<18
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Date of randomization into the maintenance phase until the first occurrence of recurrence of any symptoms or discontinuation from the study, assessed over a period of 41 months.Population: Intent-to-treat analysis set (ITT) in maintenance (MA) phase, which included participants who entered the MA phase and took at least 1 dose of study medication.
Time to first recurrence of any mood symptoms (ie, manic or depressive) associated with bipolar I disorder during the maintenance phase, after maintaining clinical stability during continued treatment with paliperidone ER over a period of 15 weeks. The time period was from occurrence of acute manic or mixed episode to Week 15. This outcome was measured using combination of various scales, hospitalization for any mood symptoms, use of any medicines for an mood episode and clinical events suggestive of recurrent mood episode associated with bipolar I disorder.
Outcome measures
| Measure |
Paliperidone ER
Acute and continuation period. Paliperidone ER: Oral tablet, 3 mg/day to 12 mg/day, Once daily.
|
Olanzapine
Acute and continuation period. Olanzapine: Oral tablet, 5 mg/day to 20 mg/day, Once daily.
|
Pali/Placebo
n=144 Participants
Maintenance period. Placebo (Paliperidone in the acute and continuation period).
|
Pali/Pali
n=146 Participants
Maintenance period. Paliperidone ER: Oral tablet, 3 mg/day to 12 mg/day, Once daily (Paliperidone in the acute and continuation period)
|
Olan/Olan
n=82 Participants
Maintenance period. Olanzapine Oral tablet, 5 mg/day to 20 mg/day, Once daily (Olanzapine in the acute and continuation period)
|
|---|---|---|---|---|---|
|
Time to Recurrence of Any Mood Symptoms (Manic or Depressive) Associated With Bipolar I Disorder
Median Time to Recurrence
|
—
|
—
|
283.0 Days
Interval 203.0 to 531.0
|
558.0 Days
Interval 401.0 to 804.0
|
NA Days
There were 23% of the subjects in Olan/Olan treatment group who reported recurrence. Hence median time to recurrence was not observed
|
|
Time to Recurrence of Any Mood Symptoms (Manic or Depressive) Associated With Bipolar I Disorder
25% Quantile of Time to Recurrence
|
—
|
—
|
85.0 Days
Interval 72.0 to 141.0
|
140.0 Days
Interval 72.0 to 274.0
|
541 Days
Interval 386.0 to
There were 23% of the subjects in Olan/Olan treatment group who reported recurrence. Hence 25% quantile of time to recurrence was not observed
|
SECONDARY outcome
Timeframe: Date of randomization into the maintenance phase until the first occurrence of recurrence of manic symptoms or discontinuation from the study, assessed over a period of 41 months.Population: Intent-to-treat analysis set in MA phase, which included participants who entered the MA phase and took at least 1 dose of study medication.
This was the key secondary efficacy end-point. Pali/Pali and Pali/Placebo were compared with each other with respect to time to recurrence of manic symptoms. The criterias used for this analysis were similar to criterias used for primary analysis.
Outcome measures
| Measure |
Paliperidone ER
Acute and continuation period. Paliperidone ER: Oral tablet, 3 mg/day to 12 mg/day, Once daily.
|
Olanzapine
Acute and continuation period. Olanzapine: Oral tablet, 5 mg/day to 20 mg/day, Once daily.
|
Pali/Placebo
n=144 Participants
Maintenance period. Placebo (Paliperidone in the acute and continuation period).
|
Pali/Pali
n=146 Participants
Maintenance period. Paliperidone ER: Oral tablet, 3 mg/day to 12 mg/day, Once daily (Paliperidone in the acute and continuation period)
|
Olan/Olan
n=82 Participants
Maintenance period. Olanzapine Oral tablet, 5 mg/day to 20 mg/day, Once daily (Olanzapine in the acute and continuation period)
|
|---|---|---|---|---|---|
|
Time to Recurrence of Manic Symptoms Associated With Bipolar I Disorder
25% Quantile of Time to Recurrence
|
—
|
—
|
194.0 Days
Interval 125.0 to 283.0
|
498.0 Days
Interval 294.0 to 813.0
|
NA Days
Interval 595.0 to
There were 11% of the subjects in the Olan/Olan group who reported recurrence of manic symptoms. Hence 25% quartile of time to recurrence was not observed.
|
|
Time to Recurrence of Manic Symptoms Associated With Bipolar I Disorder
Median Time to Recurrence
|
—
|
—
|
550.0 Days
Interval 419.0 to 878.0
|
NA Days
Interval 813.0 to
There were 21% of the subjects in the Pali/Pali group who reported recurrence of manic symptoms. Hence median time to recurrence was not observed.
|
NA Days
There were 11% of the subjects in the Olan/Olan group who reported recurrence of manic symptoms. Hence median time to recurrence was not observed.
|
SECONDARY outcome
Timeframe: Date of randomization into the maintenance phase until the first occurrence of recurrence of depressive symptoms or discontinuation from the study, assessed over a period of 41 months.Population: Intent-to-treat analysis set in MA period, which included participants who entered the maintenance phase and took at least 1 dose of study medication.
Pali/Pali and Pali/Placebo were compared with each other with respect to time to recurrence of depressive symptoms. The criterias used for this analysis were similar to criterias used for primary analysis.
Outcome measures
| Measure |
Paliperidone ER
Acute and continuation period. Paliperidone ER: Oral tablet, 3 mg/day to 12 mg/day, Once daily.
|
Olanzapine
Acute and continuation period. Olanzapine: Oral tablet, 5 mg/day to 20 mg/day, Once daily.
|
Pali/Placebo
n=144 Participants
Maintenance period. Placebo (Paliperidone in the acute and continuation period).
|
Pali/Pali
n=146 Participants
Maintenance period. Paliperidone ER: Oral tablet, 3 mg/day to 12 mg/day, Once daily (Paliperidone in the acute and continuation period)
|
Olan/Olan
n=82 Participants
Maintenance period. Olanzapine Oral tablet, 5 mg/day to 20 mg/day, Once daily (Olanzapine in the acute and continuation period)
|
|---|---|---|---|---|---|
|
Time to Recurrence of Depressive Symptoms Associated With Bipolar I Disorder
|
—
|
—
|
503.0 Days
Interval 203.0 to
There were 18% of the participants in the Pali/Placebo group who reported recurrence of depressive symptoms.
|
448.0 Days
Interval 170.0 to 750.0
|
NA Days
Interval 651.0 to
There were 12% of the participants in the Olan/Olan group who reported recurrence of depressive symptoms. Hence the 25% quartile of the time to recurrence of depressive symptoms was not observed.
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From 1st randomization into acute phase to end of acute/continuation phase (ie, up to 15 weeks after 1st randomization), or from randomization into maintenance (MA) phase to the end of MA phase (ie, up to 175 weeks (or 41 months) after 2nd randomization).Population: Intent-to-Treat
This is method by which condition of patient suffering with mania is checked. In this scale patient's condition is assessed using 11 items. A severity rating is assigned to each of 11 items based on the how subject feels of his or her condition and the physicians observation of patients behavior. The range of the scale is 0 to 60. A higher score indicates a more severe condition. Change from baseline (Day 105) in the double-blind maintenance phase to the last postbaseline assessment.
Outcome measures
| Measure |
Paliperidone ER
n=602 Participants
Acute and continuation period. Paliperidone ER: Oral tablet, 3 mg/day to 12 mg/day, Once daily.
|
Olanzapine
n=145 Participants
Acute and continuation period. Olanzapine: Oral tablet, 5 mg/day to 20 mg/day, Once daily.
|
Pali/Placebo
n=143 Participants
Maintenance period. Placebo (Paliperidone in the acute and continuation period).
|
Pali/Pali
n=144 Participants
Maintenance period. Paliperidone ER: Oral tablet, 3 mg/day to 12 mg/day, Once daily (Paliperidone in the acute and continuation period)
|
Olan/Olan
n=81 Participants
Maintenance period. Olanzapine Oral tablet, 5 mg/day to 20 mg/day, Once daily (Olanzapine in the acute and continuation period)
|
|---|---|---|---|---|---|
|
Young Mania Rating Scale (YMRS): Change From Baseline
|
-19.2 Scores on the scale
Standard Deviation 11.23
|
-19.3 Scores on the scale
Standard Deviation 10.25
|
9.0 Scores on the scale
Standard Deviation 11.78
|
4.2 Scores on the scale
Standard Deviation 9.33
|
1.3 Scores on the scale
Standard Deviation 6.26
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From 1st randomization into acute phase to end of acute/continuation phase (ie, up to 15 weeks after 1st randomization), or from randomization into maintenance (MA) phase to the end of MA phase (ie, up to 175 weeks (or 41 months) after 2nd randomization).Population: Intent-to-Treat
The MADRS consists of 10 items covering all the important complaints which patient with depression have (apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts). Item is scored from 0 (normal) to 6 (severe). Total score (0 to 60) is calculated by adding the scores of all 10 items. A higher score represents a more severe condition. Negative Change in Score Indicates Improvement.
Outcome measures
| Measure |
Paliperidone ER
n=597 Participants
Acute and continuation period. Paliperidone ER: Oral tablet, 3 mg/day to 12 mg/day, Once daily.
|
Olanzapine
n=144 Participants
Acute and continuation period. Olanzapine: Oral tablet, 5 mg/day to 20 mg/day, Once daily.
|
Pali/Placebo
n=143 Participants
Maintenance period. Placebo (Paliperidone in the acute and continuation period).
|
Pali/Pali
n=144 Participants
Maintenance period. Paliperidone ER: Oral tablet, 3 mg/day to 12 mg/day, Once daily (Paliperidone in the acute and continuation period)
|
Olan/Olan
n=81 Participants
Maintenance period. Olanzapine Oral tablet, 5 mg/day to 20 mg/day, Once daily (Olanzapine in the acute and continuation period)
|
|---|---|---|---|---|---|
|
Montgomery-Asberg Depression Rating Scale (MADRS)
|
-2.7 Scores on the scale
Standard Deviation 8.21
|
-2.7 Scores on the scale
Standard Deviation 7.82
|
6.0 Scores on the scale
Standard Deviation 9.16
|
6.1 Scores on the scale
Standard Deviation 10.10
|
2.5 Scores on the scale
Standard Deviation 7.10
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From 1st randomization into acute phase to end of acute/continuation phase (ie, up to 15 weeks after 1st randomization), or from randomization into maintenance (MA) phase to the end of MA phase (ie, up to 175 weeks (or 41 months) after 2nd randomization).Population: Intent-to-Treat
This scale is used when the clinical progress of a subject needs to be assessed in global terms, using a single measure. The GAF scale is rated with respect to psychological, social, and occupational functioning at the time of the assessment only. A higher score indicates a better functioning, with an overall range from 1 to 100. Positive Change in Score Indicates Improvement.
Outcome measures
| Measure |
Paliperidone ER
n=575 Participants
Acute and continuation period. Paliperidone ER: Oral tablet, 3 mg/day to 12 mg/day, Once daily.
|
Olanzapine
n=137 Participants
Acute and continuation period. Olanzapine: Oral tablet, 5 mg/day to 20 mg/day, Once daily.
|
Pali/Placebo
n=131 Participants
Maintenance period. Placebo (Paliperidone in the acute and continuation period).
|
Pali/Pali
n=135 Participants
Maintenance period. Paliperidone ER: Oral tablet, 3 mg/day to 12 mg/day, Once daily (Paliperidone in the acute and continuation period)
|
Olan/Olan
n=77 Participants
Maintenance period. Olanzapine Oral tablet, 5 mg/day to 20 mg/day, Once daily (Olanzapine in the acute and continuation period)
|
|---|---|---|---|---|---|
|
Global Assessment of Functioning (GAF): Change From Baseline
|
19.6 Scores on the scale
Standard Deviation 17.38
|
20.8 Scores on the scale
Standard Deviation 18.26
|
-15.2 Scores on the scale
Standard Deviation 20.93
|
-8.9 Scores on the scale
Standard Deviation 17.75
|
-4.2 Scores on the scale
Standard Deviation 13.98
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From 1st randomization into acute phase to end of acute/continuation phase (ie, up to 15 weeks after 1st randomization), or from randomization into maintenance (MA) phase to the end of MA phase (ie, up to 175 weeks (or 41 months) after 2nd randomization).Population: Intent-to-Treat
The CGI-BP-S rating scale is used to rate the severity of bipolar disorder, including both depressed and manic components, on a 7-point scale ranging from 1 (not ill) to 7 (very severely ill). This scale permits a global evaluation of the subject's bipolar condition at a given time. Negative Change in Score Indicates Improvement.
Outcome measures
| Measure |
Paliperidone ER
n=601 Participants
Acute and continuation period. Paliperidone ER: Oral tablet, 3 mg/day to 12 mg/day, Once daily.
|
Olanzapine
n=145 Participants
Acute and continuation period. Olanzapine: Oral tablet, 5 mg/day to 20 mg/day, Once daily.
|
Pali/Placebo
n=143 Participants
Maintenance period. Placebo (Paliperidone in the acute and continuation period).
|
Pali/Pali
n=144 Participants
Maintenance period. Paliperidone ER: Oral tablet, 3 mg/day to 12 mg/day, Once daily (Paliperidone in the acute and continuation period)
|
Olan/Olan
n=81 Participants
Maintenance period. Olanzapine Oral tablet, 5 mg/day to 20 mg/day, Once daily (Olanzapine in the acute and continuation period)
|
|---|---|---|---|---|---|
|
Clinical Global Impression - Bipolar Disorder - Severity of Illness (CGI-BP-S): Change From Baseline
|
-2 Scores on the scale
Interval -6.0 to 2.0
|
-3 Scores on the scale
Interval -5.0 to 2.0
|
2 Scores on the scale
Interval -1.0 to 6.0
|
0 Scores on the scale
Interval -2.0 to 5.0
|
0 Scores on the scale
Interval -1.0 to 4.0
|
Adverse Events
Paliperidone ER
Serious events: 42 serious events
Other events: 351 other events
Deaths: 0 deaths
Olanzapine
Serious events: 10 serious events
Other events: 79 other events
Deaths: 0 deaths
Pali/Placebo
Serious events: 33 serious events
Other events: 38 other events
Deaths: 0 deaths
Pali/Pali
Serious events: 16 serious events
Other events: 38 other events
Deaths: 0 deaths
Olan/Olan
Serious events: 8 serious events
Other events: 26 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Paliperidone ER
n=614 participants at risk
Acute and continuation period. Paliperidone ER: Oral tablet, 3 mg/day to 12 mg/day, Once daily.
|
Olanzapine
n=148 participants at risk
Acute and continuation period. Olanzapine: Oral tablet, 5 mg/day to 20 mg/day, Once daily.
|
Pali/Placebo
n=147 participants at risk
Maintenance period. Placebo (Paliperidone in the acute and continuation period).
|
Pali/Pali
n=149 participants at risk
Maintenance period. Paliperidone ER: Oral tablet, 3 mg/day to 12 mg/day, Once daily (Paliperidone in the acute and continuation period)
|
Olan/Olan
n=83 participants at risk
Maintenance period. Olanzapine Oral tablet, 5 mg/day to 20 mg/day, Once daily (Olanzapine in the acute and continuation period)
|
|---|---|---|---|---|---|
|
Cardiac disorders
Myocardial infarction
|
0.33%
2/614
|
0.00%
0/148
|
0.00%
0/147
|
0.00%
0/149
|
0.00%
0/83
|
|
Eye disorders
Vision blurred
|
0.16%
1/614
|
0.00%
0/148
|
0.00%
0/147
|
0.00%
0/149
|
0.00%
0/83
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/614
|
0.68%
1/148
|
0.00%
0/147
|
0.00%
0/149
|
0.00%
0/83
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/614
|
0.00%
0/148
|
0.00%
0/147
|
0.00%
0/149
|
1.2%
1/83
|
|
General disorders
Death
|
0.16%
1/614
|
0.00%
0/148
|
0.00%
0/147
|
0.67%
1/149
|
0.00%
0/83
|
|
Infections and infestations
Abdominal infection
|
0.16%
1/614
|
0.00%
0/148
|
0.00%
0/147
|
0.00%
0/149
|
0.00%
0/83
|
|
Infections and infestations
Hepatitis viral
|
0.00%
0/614
|
0.00%
0/148
|
0.00%
0/147
|
0.67%
1/149
|
0.00%
0/83
|
|
Infections and infestations
Pneumonia
|
0.00%
0/614
|
0.00%
0/148
|
0.00%
0/147
|
0.67%
1/149
|
0.00%
0/83
|
|
Infections and infestations
Sinusitis
|
0.00%
0/614
|
0.68%
1/148
|
0.00%
0/147
|
0.00%
0/149
|
0.00%
0/83
|
|
Injury, poisoning and procedural complications
Chest injury
|
0.00%
0/614
|
0.00%
0/148
|
0.00%
0/147
|
0.00%
0/149
|
1.2%
1/83
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/614
|
0.00%
0/148
|
0.00%
0/147
|
0.00%
0/149
|
1.2%
1/83
|
|
Injury, poisoning and procedural complications
Multiple fractures
|
0.16%
1/614
|
0.00%
0/148
|
0.00%
0/147
|
0.00%
0/149
|
0.00%
0/83
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
0.16%
1/614
|
0.00%
0/148
|
0.00%
0/147
|
0.00%
0/149
|
0.00%
0/83
|
|
Investigations
Blood potassium decreased
|
0.00%
0/614
|
0.00%
0/148
|
0.00%
0/147
|
0.00%
0/149
|
1.2%
1/83
|
|
Nervous system disorders
Akathisia
|
0.33%
2/614
|
0.00%
0/148
|
0.00%
0/147
|
0.00%
0/149
|
0.00%
0/83
|
|
Nervous system disorders
Extrapyramidal disorder
|
0.33%
2/614
|
0.00%
0/148
|
0.00%
0/147
|
0.00%
0/149
|
0.00%
0/83
|
|
Nervous system disorders
Hypoxic encephalopathy
|
0.00%
0/614
|
0.00%
0/148
|
0.68%
1/147
|
0.00%
0/149
|
0.00%
0/83
|
|
Nervous system disorders
Neuroleptic malignant syndrome
|
0.16%
1/614
|
0.00%
0/148
|
0.00%
0/147
|
0.00%
0/149
|
0.00%
0/83
|
|
Nervous system disorders
Psychomotor hyperactivity
|
0.33%
2/614
|
0.00%
0/148
|
0.00%
0/147
|
0.00%
0/149
|
0.00%
0/83
|
|
Psychiatric disorders
Agitation
|
0.16%
1/614
|
0.00%
0/148
|
0.00%
0/147
|
0.00%
0/149
|
0.00%
0/83
|
|
Psychiatric disorders
Alcohol abuse
|
0.33%
2/614
|
0.68%
1/148
|
0.00%
0/147
|
0.00%
0/149
|
0.00%
0/83
|
|
Psychiatric disorders
Anger
|
0.00%
0/614
|
0.00%
0/148
|
0.68%
1/147
|
0.00%
0/149
|
0.00%
0/83
|
|
Psychiatric disorders
Anxiety
|
0.16%
1/614
|
0.00%
0/148
|
0.00%
0/147
|
0.00%
0/149
|
0.00%
0/83
|
|
Psychiatric disorders
Bipolar I disorder
|
0.16%
1/614
|
0.00%
0/148
|
0.00%
0/147
|
0.00%
0/149
|
0.00%
0/83
|
|
Psychiatric disorders
Catatonia
|
0.00%
0/614
|
0.68%
1/148
|
0.00%
0/147
|
0.00%
0/149
|
0.00%
0/83
|
|
Psychiatric disorders
Completed suicide
|
0.16%
1/614
|
0.00%
0/148
|
0.00%
0/147
|
0.00%
0/149
|
0.00%
0/83
|
|
Psychiatric disorders
Depression
|
0.65%
4/614
|
0.68%
1/148
|
5.4%
8/147
|
2.7%
4/149
|
1.2%
1/83
|
|
Psychiatric disorders
Depressive symptom
|
0.00%
0/614
|
0.00%
0/148
|
0.00%
0/147
|
0.67%
1/149
|
0.00%
0/83
|
|
Psychiatric disorders
Hypomania
|
0.16%
1/614
|
0.00%
0/148
|
0.00%
0/147
|
0.67%
1/149
|
0.00%
0/83
|
|
Psychiatric disorders
Insomnia
|
0.16%
1/614
|
0.00%
0/148
|
0.00%
0/147
|
0.00%
0/149
|
0.00%
0/83
|
|
Psychiatric disorders
Major depression
|
0.00%
0/614
|
0.00%
0/148
|
0.68%
1/147
|
0.67%
1/149
|
0.00%
0/83
|
|
Psychiatric disorders
Mania
|
1.6%
10/614
|
4.1%
6/148
|
15.0%
22/147
|
2.0%
3/149
|
4.8%
4/83
|
|
Psychiatric disorders
Pressure of speech
|
0.00%
0/614
|
0.00%
0/148
|
0.00%
0/147
|
0.67%
1/149
|
0.00%
0/83
|
|
Psychiatric disorders
Psychotic disorder
|
0.00%
0/614
|
0.68%
1/148
|
0.68%
1/147
|
0.00%
0/149
|
0.00%
0/83
|
|
Psychiatric disorders
Self-injurious ideation
|
0.00%
0/614
|
0.00%
0/148
|
0.00%
0/147
|
0.67%
1/149
|
0.00%
0/83
|
|
Psychiatric disorders
Suicidal behaviour
|
0.16%
1/614
|
0.00%
0/148
|
0.00%
0/147
|
0.00%
0/149
|
0.00%
0/83
|
|
Psychiatric disorders
Suicidal ideation
|
0.98%
6/614
|
0.00%
0/148
|
0.00%
0/147
|
0.00%
0/149
|
0.00%
0/83
|
|
Psychiatric disorders
Suicide attempt
|
0.16%
1/614
|
0.00%
0/148
|
0.00%
0/147
|
0.00%
0/149
|
0.00%
0/83
|
|
Psychiatric disorders
Tachyphrenia
|
0.00%
0/614
|
0.00%
0/148
|
0.00%
0/147
|
0.67%
1/149
|
0.00%
0/83
|
|
Skin and subcutaneous tissue disorders
Leukoplakia
|
0.16%
1/614
|
0.00%
0/148
|
0.00%
0/147
|
0.00%
0/149
|
0.00%
0/83
|
|
Surgical and medical procedures
Breast operation
|
0.16%
1/614
|
0.00%
0/148
|
0.00%
0/147
|
0.00%
0/149
|
0.00%
0/83
|
|
Surgical and medical procedures
Mastectomy
|
0.00%
0/614
|
0.00%
0/148
|
0.00%
0/147
|
0.67%
1/149
|
0.00%
0/83
|
|
Surgical and medical procedures
Nasal operation
|
0.00%
0/614
|
0.00%
0/148
|
0.00%
0/147
|
0.67%
1/149
|
0.00%
0/83
|
|
Surgical and medical procedures
Sinus operation
|
0.16%
1/614
|
0.00%
0/148
|
0.00%
0/147
|
0.00%
0/149
|
0.00%
0/83
|
|
Vascular disorders
Hypertension
|
0.33%
2/614
|
0.00%
0/148
|
0.00%
0/147
|
0.00%
0/149
|
0.00%
0/83
|
|
Vascular disorders
Orthostatic hypotension
|
0.16%
1/614
|
0.00%
0/148
|
0.00%
0/147
|
0.00%
0/149
|
0.00%
0/83
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer stage III
|
0.16%
1/614
|
0.00%
0/148
|
0.00%
0/147
|
0.00%
0/149
|
0.00%
0/83
|
Other adverse events
| Measure |
Paliperidone ER
n=614 participants at risk
Acute and continuation period. Paliperidone ER: Oral tablet, 3 mg/day to 12 mg/day, Once daily.
|
Olanzapine
n=148 participants at risk
Acute and continuation period. Olanzapine: Oral tablet, 5 mg/day to 20 mg/day, Once daily.
|
Pali/Placebo
n=147 participants at risk
Maintenance period. Placebo (Paliperidone in the acute and continuation period).
|
Pali/Pali
n=149 participants at risk
Maintenance period. Paliperidone ER: Oral tablet, 3 mg/day to 12 mg/day, Once daily (Paliperidone in the acute and continuation period)
|
Olan/Olan
n=83 participants at risk
Maintenance period. Olanzapine Oral tablet, 5 mg/day to 20 mg/day, Once daily (Olanzapine in the acute and continuation period)
|
|---|---|---|---|---|---|
|
Nervous system disorders
Extrapyramidal disorder
|
8.8%
54/614
|
2.7%
4/148
|
0.68%
1/147
|
1.3%
2/149
|
1.2%
1/83
|
|
Nervous system disorders
Headache
|
12.7%
78/614
|
9.5%
14/148
|
4.8%
7/147
|
2.7%
4/149
|
8.4%
7/83
|
|
Nervous system disorders
Sedation
|
6.2%
38/614
|
16.9%
25/148
|
0.00%
0/147
|
0.00%
0/149
|
2.4%
2/83
|
|
Nervous system disorders
Somnolence
|
12.4%
76/614
|
15.5%
23/148
|
0.00%
0/147
|
3.4%
5/149
|
1.2%
1/83
|
|
Gastrointestinal disorders
Dry mouth
|
4.6%
28/614
|
9.5%
14/148
|
1.4%
2/147
|
0.67%
1/149
|
1.2%
1/83
|
|
Gastrointestinal disorders
Nausea
|
5.4%
33/614
|
1.4%
2/148
|
1.4%
2/147
|
0.67%
1/149
|
0.00%
0/83
|
|
Investigations
Weight decreased
|
1.1%
7/614
|
0.00%
0/148
|
6.1%
9/147
|
2.7%
4/149
|
1.2%
1/83
|
|
Investigations
Weight increased
|
8.3%
51/614
|
12.2%
18/148
|
6.8%
10/147
|
8.1%
12/149
|
8.4%
7/83
|
|
Metabolism and nutrition disorders
Increased appetite
|
3.7%
23/614
|
8.8%
13/148
|
0.00%
0/147
|
0.67%
1/149
|
0.00%
0/83
|
|
Nervous system disorders
Akathisia
|
13.5%
83/614
|
7.4%
11/148
|
0.68%
1/147
|
0.67%
1/149
|
2.4%
2/83
|
|
Nervous system disorders
Dizziness
|
6.7%
41/614
|
2.7%
4/148
|
0.68%
1/147
|
2.7%
4/149
|
0.00%
0/83
|
|
Nervous system disorders
Tremor
|
5.5%
34/614
|
2.7%
4/148
|
0.00%
0/147
|
0.67%
1/149
|
3.6%
3/83
|
|
Psychiatric disorders
Insomnia
|
13.5%
83/614
|
10.1%
15/148
|
9.5%
14/147
|
8.7%
13/149
|
8.4%
7/83
|
Additional Information
Clinical Leader
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Phone: 609-730-2436
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60