Trial Outcomes & Findings for Evaluation of Efficacy and Safety of Iloperidone in the Acute Treatment of Manic or Mixed Episodes Associated With Bipolar I Disorder (NCT NCT04819776)
NCT ID: NCT04819776
Last Updated: 2024-04-18
Results Overview
The Young Mania Rating Scale (YMRS) is an 11-item scale. Individual item scores are summed for a total possible score of 0 (best) to 60 (worst).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
417 participants
Primary outcome timeframe
Week 4
Results posted on
2024-04-18
Participant Flow
Safety analyses included patients who received 1 or more doses of study medication. Of the 417 randomized, 414 received at least one dose of study medication.
Participant milestones
| Measure |
Iloperidone
Iloperidone: Oral iloperidone
|
Placebo
Iloperidone Placebo: Oral placebo
|
|---|---|---|
|
Overall Study
STARTED
|
206
|
208
|
|
Overall Study
COMPLETED
|
139
|
153
|
|
Overall Study
NOT COMPLETED
|
67
|
55
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluation of Efficacy and Safety of Iloperidone in the Acute Treatment of Manic or Mixed Episodes Associated With Bipolar I Disorder
Baseline characteristics by cohort
| Measure |
Iloperidone
n=206 Participants
Iloperidone: Oral iloperidone
|
Placebo
n=208 Participants
Iloperidone Placebo: Oral placebo
|
Total
n=414 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
42.9 years
STANDARD_DEVIATION 12.76 • n=93 Participants
|
43.9 years
STANDARD_DEVIATION 12.55 • n=4 Participants
|
43.4 years
STANDARD_DEVIATION 12.65 • n=27 Participants
|
|
Sex: Female, Male
Female
|
90 Participants
n=93 Participants
|
96 Participants
n=4 Participants
|
186 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
116 Participants
n=93 Participants
|
112 Participants
n=4 Participants
|
228 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
White
|
133 Participants
n=93 Participants
|
132 Participants
n=4 Participants
|
265 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
62 Participants
n=93 Participants
|
55 Participants
n=4 Participants
|
117 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
1 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Other
|
9 Participants
n=93 Participants
|
15 Participants
n=4 Participants
|
24 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Week 4Population: Efficacy analyses were based on the Intent-To-Treat (ITT) population, which included all randomized patients who received a dose of study drug and had at least one valid post-baseline efficacy measurement while on study medication. Of the 417 randomized, 392 received at least one dose of study medication and had at least one valid post-baseline efficacy measurement.
The Young Mania Rating Scale (YMRS) is an 11-item scale. Individual item scores are summed for a total possible score of 0 (best) to 60 (worst).
Outcome measures
| Measure |
Iloperidone
n=198 Participants
Iloperidone: Oral iloperidone
|
Placebo
n=194 Participants
Iloperidone Placebo: Oral placebo
|
|---|---|---|
|
Change From Baseline to Week 4 in Young Mania Rating Scale (YMRS) Total Score
|
-14.0 Change from Baseline in YMRS Total Score
Standard Error 0.64
|
-10.0 Change from Baseline in YMRS Total Score
Standard Error 0.63
|
Adverse Events
Iloperidone
Serious events: 4 serious events
Other events: 88 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 25 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Iloperidone
n=206 participants at risk
Iloperidone: Oral iloperidone
|
Placebo
n=208 participants at risk
Iloperidone Placebo: Oral placebo
|
|---|---|---|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.49%
1/206 • AE data was collected during the 28 day study period plus a 7 day follow up period.
|
0.00%
0/208 • AE data was collected during the 28 day study period plus a 7 day follow up period.
|
|
Nervous system disorders
Sedation
|
0.49%
1/206 • AE data was collected during the 28 day study period plus a 7 day follow up period.
|
0.00%
0/208 • AE data was collected during the 28 day study period plus a 7 day follow up period.
|
|
Reproductive system and breast disorders
Spontaneous penile erection
|
0.49%
1/206 • AE data was collected during the 28 day study period plus a 7 day follow up period.
|
0.00%
0/208 • AE data was collected during the 28 day study period plus a 7 day follow up period.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.49%
1/206 • AE data was collected during the 28 day study period plus a 7 day follow up period.
|
0.00%
0/208 • AE data was collected during the 28 day study period plus a 7 day follow up period.
|
|
Psychiatric disorders
Bipolar disorder (depression)
|
0.00%
0/206 • AE data was collected during the 28 day study period plus a 7 day follow up period.
|
0.48%
1/208 • AE data was collected during the 28 day study period plus a 7 day follow up period.
|
Other adverse events
| Measure |
Iloperidone
n=206 participants at risk
Iloperidone: Oral iloperidone
|
Placebo
n=208 participants at risk
Iloperidone Placebo: Oral placebo
|
|---|---|---|
|
Cardiac disorders
Tachycardia
|
17.5%
36/206 • AE data was collected during the 28 day study period plus a 7 day follow up period.
|
5.3%
11/208 • AE data was collected during the 28 day study period plus a 7 day follow up period.
|
|
Nervous system disorders
Dizziness
|
11.2%
23/206 • AE data was collected during the 28 day study period plus a 7 day follow up period.
|
0.96%
2/208 • AE data was collected during the 28 day study period plus a 7 day follow up period.
|
|
Gastrointestinal disorders
Dry mouth
|
9.2%
19/206 • AE data was collected during the 28 day study period plus a 7 day follow up period.
|
1.9%
4/208 • AE data was collected during the 28 day study period plus a 7 day follow up period.
|
|
Investigations
Alanine aminotransferase increased
|
7.3%
15/206 • AE data was collected during the 28 day study period plus a 7 day follow up period.
|
0.48%
1/208 • AE data was collected during the 28 day study period plus a 7 day follow up period.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
6.3%
13/206 • AE data was collected during the 28 day study period plus a 7 day follow up period.
|
1.4%
3/208 • AE data was collected during the 28 day study period plus a 7 day follow up period.
|
|
Investigations
Weight increased
|
5.8%
12/206 • AE data was collected during the 28 day study period plus a 7 day follow up period.
|
1.4%
3/208 • AE data was collected during the 28 day study period plus a 7 day follow up period.
|
|
Nervous system disorders
Somnolence
|
5.3%
11/206 • AE data was collected during the 28 day study period plus a 7 day follow up period.
|
1.9%
4/208 • AE data was collected during the 28 day study period plus a 7 day follow up period.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place