Trial Outcomes & Findings for Iloperidone in Mixed States of Bipolar Disorder (NCT NCT02413918)
NCT ID: NCT02413918
Last Updated: 2018-02-08
Results Overview
The Bipolar Inventory of Symptoms Scale is a reliable and valid measure which assesses Depression and Mania symptoms of bipolar disorder. There are 42 items; each item is rated on a 0-4 scale. The BISS is a clinician-rated instrument. The Scale is rated as follows: 0 Not at all 1. Slight 2. Mild 3. Moderate 4. Severe Each of the 42 items is rated separately, with a score, based on the most recent 7 day period. For Depression: Items 1-21 items of the assessment are summed up and multiplied by 4 to give a cumulative score out of 84. The higher the score, the more severe the depression. For Mania: Items 22-42 are summed up and multiplied by 4 to give a cumulative score out of 84. The higher the score, the more severe the mania. The mean is calculated from the change in score between baseline and week 20.
COMPLETED
PHASE4
41 participants
Baseline and 20 weeks
2018-02-08
Participant Flow
Recruitment occurred April 2013 to April 2015 from patients in the clinic or from responders to t.v. advertisements.
Subjects who met inclusion criteria at screening visit were started on study medication at visit 2.
Participant milestones
| Measure |
Open Label Iloperidone
open label iloperidone (oral tablet, 6mg-24mg, QD, 20 weeks) as adjunct to current lithium, divalproex, or lamotrigine.
iloperidone: Qualifying subjects will take iloperidone starting at 2mg and up to a minimum of 12mg, maximum of 24mg, for 20 weeks in conjunction to the subjects current lithium, and or divalproex, and or lamotrigine.
|
|---|---|
|
Overall Study
STARTED
|
41
|
|
Overall Study
COMPLETED
|
16
|
|
Overall Study
NOT COMPLETED
|
25
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Iloperidone in Mixed States of Bipolar Disorder
Baseline characteristics by cohort
| Measure |
Open Label Iloperidone
n=31 Participants
open label iloperidone (oral tablet, 6mg-24mg, QD, 20 weeks) as adjunct to current lithium, divalproex, or lamotrigine.
iloperidone: Qualifying subjects will take iloperidone starting at 2mg and up to a minimum of 12mg, maximum of 24mg, for 20 weeks in conjunction to the subjects current lithium, and or divalproex, and or lamotrigine.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
30 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and 20 weeksPopulation: Subjects who are currently treated with mood stabilizers (Lithium, Divalproex or Lamotrigine), with a diagnosis of Bipolar Disorder I or II.
The Bipolar Inventory of Symptoms Scale is a reliable and valid measure which assesses Depression and Mania symptoms of bipolar disorder. There are 42 items; each item is rated on a 0-4 scale. The BISS is a clinician-rated instrument. The Scale is rated as follows: 0 Not at all 1. Slight 2. Mild 3. Moderate 4. Severe Each of the 42 items is rated separately, with a score, based on the most recent 7 day period. For Depression: Items 1-21 items of the assessment are summed up and multiplied by 4 to give a cumulative score out of 84. The higher the score, the more severe the depression. For Mania: Items 22-42 are summed up and multiplied by 4 to give a cumulative score out of 84. The higher the score, the more severe the mania. The mean is calculated from the change in score between baseline and week 20.
Outcome measures
| Measure |
Mean Change in Depression for Study Completers
n=16 Participants
Measurement of mean change in depression for all subjects who entered study and completed 20 weeks
|
Mean Change in Mania for Study Completers
n=16 Participants
Measurement of mean change in mania for all study participants who completed 20 weeks.
|
Mean Change in Depression for All Study Participants
n=41 Participants
Mean change in depression for all study participants, including early terminators.
|
Mean Change in Mania for All Study Participants
n=41 Participants
Mean change in mania for all study participants, including early terminators
|
|---|---|---|---|---|
|
Measure of Response by Change From Baseline to End of Study in BISS Depression and Mania Scale Scores
|
35.7 percentage change in score on BISS scale
|
61.8 percentage change in score on BISS scale
|
25 percentage change in score on BISS scale
|
48 percentage change in score on BISS scale
|
Adverse Events
Open Label Iloperidone
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Open Label Iloperidone
n=31 participants at risk
open label iloperidone (oral tablet, 6mg-24mg, QD, 20 weeks) as adjunct to current lithium, divalproex, or lamotrigine.
iloperidone: Qualifying subjects will take iloperidone starting at 2mg and up to a minimum of 12mg, maximum of 24mg, for 20 weeks in conjunction to the subjects current lithium, and or divalproex, and or lamotrigine.
|
|---|---|
|
Gastrointestinal disorders
dry mouth
|
38.7%
12/31 • Number of events 12 • 3 years
|
|
Nervous system disorders
dizzy/lightheaded
|
25.8%
8/31 • Number of events 10 • 3 years
|
|
Gastrointestinal disorders
Diarrhea/Loose stool
|
12.9%
4/31 • Number of events 4 • 3 years
|
|
Cardiac disorders
Heart palpitations
|
29.0%
9/31 • Number of events 9 • 3 years
|
|
Cardiac disorders
Atrial fibrilation
|
6.5%
2/31 • Number of events 2 • 3 years
|
|
Immune system disorders
Flu symptoms/muscle weakness/fatigue
|
19.4%
6/31 • Number of events 8 • 3 years
|
|
Psychiatric disorders
Anxiety
|
12.9%
4/31 • Number of events 4 • 3 years
|
|
Immune system disorders
Nasal Congestion
|
16.1%
5/31 • Number of events 5 • 3 years
|
|
Renal and urinary disorders
Urinary tract infection
|
6.5%
2/31 • Number of events 2 • 3 years
|
|
Vascular disorders
Hypertension(high blood pressure)
|
6.5%
2/31 • Number of events 2 • 3 years
|
|
Renal and urinary disorders
Urinary Incontinence
|
25.8%
8/31 • Number of events 8 • 3 years
|
|
Metabolism and nutrition disorders
weight gain
|
25.8%
8/31 • Number of events 8 • 3 years
|
|
Psychiatric disorders
Decreased concertration
|
16.1%
5/31 • Number of events 5 • 3 years
|
|
Endocrine disorders
Increased Thirst
|
35.5%
11/31 • Number of events 14 • 3 years
|
|
Gastrointestinal disorders
Abdominal Bloating
|
6.5%
2/31 • Number of events 2 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Tremors
|
16.1%
5/31 • Number of events 5 • 3 years
|
|
Blood and lymphatic system disorders
Edema of the legs
|
6.5%
2/31 • Number of events 2 • 3 years
|
|
General disorders
Drowsiness
|
16.1%
5/31 • Number of events 5 • 3 years
|
|
Musculoskeletal and connective tissue disorders
worsening of Fibromyalgia
|
6.5%
2/31 • Number of events 2 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of breath
|
6.5%
2/31 • Number of events 2 • 3 years
|
|
Eye disorders
Blurry vision
|
6.5%
2/31 • Number of events 2 • 3 years
|
|
Nervous system disorders
Migraine headache
|
9.7%
3/31 • Number of events 3 • 3 years
|
|
Eye disorders
Dry Eyes
|
6.5%
2/31 • Number of events 2 • 3 years
|
Additional Information
Charles Bowden, MD
University of Texas HEalth Science Center San Antonio
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place