Trial Outcomes & Findings for Assessment and Comparison of Metabolic Changes in Non-psychotic Adults Taking Iloperidone or Olanzapine or Placebo (NCT NCT01920802)
NCT ID: NCT01920802
Last Updated: 2017-03-20
Results Overview
Delineate a pathophysiological mechanism of antipsychotic induced weight gain
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
31 participants
Primary outcome timeframe
baseline and 6 week visit
Results posted on
2017-03-20
Participant Flow
There were a total of 69 consents in the study, 31 of which were randomized (started study medication). 24 subjects completed the study. The baseline characteristics reported were for the 24 subjects who completed the study.
Participant milestones
| Measure |
Olanzapine
5mg BID olanzapine for up to 4 weeks
olanzapine: 5mg BID up to 4 weeks
|
Iloperidone
6mg BID iloperidone up to 4 weeks
iloperidone: 6 mg BID up to 4 weeks
|
Placebo
BID placebo up to 4 weeks
Placebo: BID up to 4 weeks
|
|---|---|---|---|
|
Overall Study
STARTED
|
11
|
9
|
11
|
|
Overall Study
COMPLETED
|
7
|
7
|
10
|
|
Overall Study
NOT COMPLETED
|
4
|
2
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Assessment and Comparison of Metabolic Changes in Non-psychotic Adults Taking Iloperidone or Olanzapine or Placebo
Baseline characteristics by cohort
| Measure |
Olanzapine
n=7 Participants
5mg BID olanzapine for up to 4 weeks
olanzapine: 5mg BID up to 4 weeks
|
Iloperidone
n=7 Participants
6mg BID iloperidone up to 4 weeks
iloperidone: 6 mg BID up to 4 weeks
|
Placebo
n=10 Participants
BID placebo up to 4 weeks
Placebo: BID up to 4 weeks
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
24 Participants
n=7 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
18 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
14 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Region of Enrollment
United States
|
7 participants
n=99 Participants
|
7 participants
n=107 Participants
|
10 participants
n=206 Participants
|
24 participants
n=7 Participants
|
|
Starting BMI
|
22.7 kg/m^2
STANDARD_DEVIATION 0.3 • n=99 Participants
|
23.6 kg/m^2
STANDARD_DEVIATION 0.6 • n=107 Participants
|
22.7 kg/m^2
STANDARD_DEVIATION 0.5 • n=206 Participants
|
23.0 kg/m^2
STANDARD_DEVIATION 0.5 • n=7 Participants
|
|
Education (years)
|
16.4 years
n=99 Participants
|
13.6 years
n=107 Participants
|
14.9 years
n=206 Participants
|
15 years
n=7 Participants
|
PRIMARY outcome
Timeframe: baseline and 6 week visitDelineate a pathophysiological mechanism of antipsychotic induced weight gain
Outcome measures
| Measure |
Olanzapine
n=7 Participants
5mg BID olanzapine for up to 4 weeks
olanzapine: 5mg BID up to 4 weeks
|
Iloperidone
n=7 Participants
6mg BID iloperidone up to 4 weeks
iloperidone: 6 mg BID up to 4 weeks
|
Placebo
n=10 Participants
BID placebo up to 4 weeks
Placebo: BID up to 4 weeks
|
|---|---|---|---|
|
Change in Body Weight
|
3.2 kg
Standard Deviation 1.0
|
0.8 kg
Standard Deviation 0.7
|
0.4 kg
Standard Deviation 0.5
|
PRIMARY outcome
Timeframe: Baseline to Day 28Total fat mass (excluding head) from baseline to Day 28
Outcome measures
| Measure |
Olanzapine
n=7 Participants
5mg BID olanzapine for up to 4 weeks
olanzapine: 5mg BID up to 4 weeks
|
Iloperidone
n=7 Participants
6mg BID iloperidone up to 4 weeks
iloperidone: 6 mg BID up to 4 weeks
|
Placebo
n=10 Participants
BID placebo up to 4 weeks
Placebo: BID up to 4 weeks
|
|---|---|---|---|
|
Change in Adiposity
Baseline
|
11942 grams
Standard Deviation 3635
|
14741 grams
Standard Deviation 7349
|
11690 grams
Standard Deviation 5469
|
|
Change in Adiposity
Day 28
|
13312 grams
Standard Deviation 4246
|
16366 grams
Standard Deviation 6857
|
12081 grams
Standard Deviation 4649
|
SECONDARY outcome
Timeframe: change in baseline to Day 3Leptin levels measured at Day 3 compared to baseline
Outcome measures
| Measure |
Olanzapine
n=7 Participants
5mg BID olanzapine for up to 4 weeks
olanzapine: 5mg BID up to 4 weeks
|
Iloperidone
n=7 Participants
6mg BID iloperidone up to 4 weeks
iloperidone: 6 mg BID up to 4 weeks
|
Placebo
n=10 Participants
BID placebo up to 4 weeks
Placebo: BID up to 4 weeks
|
|---|---|---|---|
|
Change in Leptin
|
2.47 ng/dL
Standard Deviation 1.17
|
1.76 ng/dL
Standard Deviation 0.8
|
1.16 ng/dL
Standard Deviation 1.15
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to study termination (about 12 weeks)To quantify, prospectively, change in glucose from baseline to Day 28
Outcome measures
| Measure |
Olanzapine
n=7 Participants
5mg BID olanzapine for up to 4 weeks
olanzapine: 5mg BID up to 4 weeks
|
Iloperidone
n=7 Participants
6mg BID iloperidone up to 4 weeks
iloperidone: 6 mg BID up to 4 weeks
|
Placebo
n=10 Participants
BID placebo up to 4 weeks
Placebo: BID up to 4 weeks
|
|---|---|---|---|
|
Change Glucose in People Taking Olanzapine or Iloperidone
Baseline
|
11500.71 mg/dL
Standard Deviation 2721.448
|
14430 mg/dL
Standard Deviation 2148.776
|
10925.5 mg/dL
Standard Deviation 1134.236
|
|
Change Glucose in People Taking Olanzapine or Iloperidone
Day 28
|
11276.43 mg/dL
Standard Deviation 1231.773
|
13975 mg/dL
Standard Deviation 3813.754
|
12179.5 mg/dL
Standard Deviation 1252.944
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to Day 28Change in Insulin levels from baseline to Day 28
Outcome measures
| Measure |
Olanzapine
n=7 Participants
5mg BID olanzapine for up to 4 weeks
olanzapine: 5mg BID up to 4 weeks
|
Iloperidone
n=7 Participants
6mg BID iloperidone up to 4 weeks
iloperidone: 6 mg BID up to 4 weeks
|
Placebo
n=10 Participants
BID placebo up to 4 weeks
Placebo: BID up to 4 weeks
|
|---|---|---|---|
|
Change in Insulin
Baseline
|
9.7749 mlU/L
Standard Deviation 3.42727
|
9.9316 mlU/L
Standard Deviation 2.29266
|
10.9619 mlU/L
Standard Deviation 2.66812
|
|
Change in Insulin
Day 28
|
12.0862 mlU/L
Standard Deviation 7.39234
|
10.873 mlU/L
Standard Deviation 5.9051
|
10.785 mlU/L
Standard Deviation 2.62637
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to Day 28Homeostatic model assessment for Insulin Resistance (HOMA-IR) is a method for assessing β-cell function and insulin resistance (IR) from basal (fasting) glucose and insulin.
Outcome measures
| Measure |
Olanzapine
n=7 Participants
5mg BID olanzapine for up to 4 weeks
olanzapine: 5mg BID up to 4 weeks
|
Iloperidone
n=7 Participants
6mg BID iloperidone up to 4 weeks
iloperidone: 6 mg BID up to 4 weeks
|
Placebo
n=10 Participants
BID placebo up to 4 weeks
Placebo: BID up to 4 weeks
|
|---|---|---|---|
|
Insulin Resistance
Baseline
|
2.0477 HOMA-IR score
Standard Deviation 0.70188
|
2.0661 HOMA-IR score
Standard Deviation 0.56517
|
2.2988 HOMA-IR score
Standard Deviation 0.52346
|
|
Insulin Resistance
Day 28
|
2.6147 HOMA-IR score
Standard Deviation 1.78901
|
2.4733 HOMA-IR score
Standard Deviation 1.60855
|
2.3362 HOMA-IR score
Standard Deviation 0.68093
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to Day 28Total grams of food consumed
Outcome measures
| Measure |
Olanzapine
n=7 Participants
5mg BID olanzapine for up to 4 weeks
olanzapine: 5mg BID up to 4 weeks
|
Iloperidone
n=7 Participants
6mg BID iloperidone up to 4 weeks
iloperidone: 6 mg BID up to 4 weeks
|
Placebo
n=10 Participants
BID placebo up to 4 weeks
Placebo: BID up to 4 weeks
|
|---|---|---|---|
|
Change in Food Intake
Baseline
|
1101.7715 grams
Standard Deviation 288.60787
|
1196.6557 grams
Standard Deviation 527.22574
|
1567.526 grams
Standard Deviation 608.53519
|
|
Change in Food Intake
Day 28
|
1198.4071 grams
Standard Deviation 303.15123
|
1154.1286 grams
Standard Deviation 686.19597
|
1458.108 grams
Standard Deviation 731.06392
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to Day 28Change in lipid metabolism as measured by cholesterol/HDL ratio
Outcome measures
| Measure |
Olanzapine
n=7 Participants
5mg BID olanzapine for up to 4 weeks
olanzapine: 5mg BID up to 4 weeks
|
Iloperidone
n=7 Participants
6mg BID iloperidone up to 4 weeks
iloperidone: 6 mg BID up to 4 weeks
|
Placebo
n=10 Participants
BID placebo up to 4 weeks
Placebo: BID up to 4 weeks
|
|---|---|---|---|
|
Change in Lipid Metabolism
Baseline
|
2.71 ratio
Standard Deviation 0.756
|
2.57 ratio
Standard Deviation 0.787
|
2.7 ratio
Standard Deviation 0.483
|
|
Change in Lipid Metabolism
Day 28
|
3.14 ratio
Standard Deviation 1.069
|
2.57 ratio
Standard Deviation 0.787
|
2.5 ratio
Standard Deviation 0.527
|
Adverse Events
Olanzapine
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Iloperidone
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Olanzapine
n=7 participants at risk
5mg BID olanzapine for up to 4 weeks
olanzapine: 5mg BID up to 4 weeks
|
Iloperidone
n=7 participants at risk
6mg BID iloperidone up to 4 weeks
iloperidone: 6 mg BID up to 4 weeks
|
Placebo
n=10 participants at risk
BID placebo up to 4 weeks
Placebo: BID up to 4 weeks
|
|---|---|---|---|
|
General disorders
Drowsiness
|
85.7%
6/7 • Number of events 6 • 4 weeks
|
85.7%
6/7 • Number of events 6 • 4 weeks
|
20.0%
2/10 • Number of events 2 • 4 weeks
|
Additional Information
Jeffrey A. Lieberman, MD
New York State Psychiatric Institute
Phone: 646-774-8436
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place