Trial Outcomes & Findings for Iloperidone Augmentation of SSRIs for Patients With Major Depressive Disorder With Residual Anger and Irritability (NCT NCT01464229)
NCT ID: NCT01464229
Last Updated: 2017-04-11
Results Overview
Of the 20 patients randomized, data was analyzed for 13 completers. Symptom Questionnaire (SQ) Anger/Hostility Scale; this is a 23-item subscale of the 92-item Symptom Questionnaire. This score ranges from 0 to 23; higher values represent higher anger and hostility.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
20 participants
Primary outcome timeframe
9 weeks
Results posted on
2017-04-11
Participant Flow
Participant milestones
| Measure |
Iloperidone, Then Placebo
Iloperidone (1-8 mg) for 4 weeks, then placebo for 4 weeks; in addition to standard SSRI antidepressant
|
Placebo, Then Iloperidone
Placebo: Placebo for 4 weeks, then iloperidone for 4 weeks; in addition to standard SSRI antidepressant
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
|
Overall Study
COMPLETED
|
5
|
8
|
|
Overall Study
NOT COMPLETED
|
5
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
20 patients randomized into the study.
Baseline characteristics by cohort
| Measure |
Iloperidone, Then Placebo
n=10 Participants
Iloperidone: Iloperidone 1-8 mg for 4 weeks then placebo for 4 weeks, in addition to SSRI antidepressant
|
Placebo, Then Iloperidone
n=10 Participants
Placebo: Placebo for 4 weeks then iloperidone for 4 weeks; addition to standard SSRI antidepressant
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=10 Participants
|
10 Participants
n=10 Participants
|
20 Participants
n=20 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
|
Sex/Gender, Customized
Females
|
6 Participants
n=6 Participants • 20 patients randomized into the study.
|
8 Participants
n=8 Participants • 20 patients randomized into the study.
|
14 Participants
n=14 Participants • 20 patients randomized into the study.
|
|
Sex/Gender, Customized
Males
|
4 Participants
n=4 Participants • 20 patients randomized into the study.
|
2 Participants
n=2 Participants • 20 patients randomized into the study.
|
6 Participants
n=6 Participants • 20 patients randomized into the study.
|
PRIMARY outcome
Timeframe: 9 weeksOf the 20 patients randomized, data was analyzed for 13 completers. Symptom Questionnaire (SQ) Anger/Hostility Scale; this is a 23-item subscale of the 92-item Symptom Questionnaire. This score ranges from 0 to 23; higher values represent higher anger and hostility.
Outcome measures
| Measure |
Iloperidone, Then Placebo
n=5 Participants
Iloperidone: Iloperidone 1-8 mg for 4 weeks then placebo for 4 weeks; addition to SSRI antidepressant
|
Placebo, Then Iloperidone
n=8 Participants
Placebo: Placebo for 4 weeks then iloperidone for 4 weeks; addition to standard SSRI antidepressant
|
|---|---|---|
|
SQ Anger/Hostility Scale
Iloperidone
|
4.8 Score on Anger/Hostility Scale
Standard Deviation 4.3
|
8 Score on Anger/Hostility Scale
Standard Deviation 6.2
|
|
SQ Anger/Hostility Scale
Placebo
|
6.7 Score on Anger/Hostility Scale
Standard Deviation 5.8
|
7.5 Score on Anger/Hostility Scale
Standard Deviation 7.2
|
Adverse Events
Iloperidone
Serious events: 2 serious events
Other events: 13 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Iloperidone
n=13 participants at risk
|
Placebo
n=13 participants at risk
|
|---|---|---|
|
Cardiac disorders
Palpitations
|
7.7%
1/13 • Number of events 1
|
0.00%
0/13
|
|
General disorders
Increased Irritability
|
7.7%
1/13 • Number of events 1
|
0.00%
0/13
|
Other adverse events
| Measure |
Iloperidone
n=13 participants at risk
|
Placebo
n=13 participants at risk
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Dry Mouth
|
46.2%
6/13
|
7.7%
1/13
|
|
Nervous system disorders
Somnolence
|
15.4%
2/13
|
15.4%
2/13
|
|
Nervous system disorders
Headaches
|
15.4%
2/13
|
7.7%
1/13
|
|
Gastrointestinal disorders
Nausea
|
15.4%
2/13
|
7.7%
1/13
|
|
Gastrointestinal disorders
Cramping
|
7.7%
1/13
|
0.00%
0/13
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place