Trial Outcomes & Findings for Metabolic Effects of Antipsychotics in Children (NCT NCT00205699)
NCT ID: NCT00205699
Last Updated: 2018-06-15
Results Overview
This study hypothesized that antipsychotic treatment would increase percent total body fat, as measured by whole body dual energy x-ray absorptiometry (DEXA), with larger adverse effects for olanzapine.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
144 participants
Primary outcome timeframe
12 weeks
Results posted on
2018-06-15
Participant Flow
Post-enrollment screening for inclusion and exclusion criteria, e.g. for exclusionary conditions like diabetes mellitus.
Participant milestones
| Measure |
Risperidone
12 weeks of randomized treatment with flexibly dosed risperidone
|
Olanzapine
12 weeks of randomized treatment with flexibly dosed olanzapine
|
Aripiprazole
12 weeks of randomized treatment with flexibly dosed aripiprazole
|
|---|---|---|---|
|
Overall Study
STARTED
|
49
|
46
|
49
|
|
Overall Study
COMPLETED
|
46
|
40
|
43
|
|
Overall Study
NOT COMPLETED
|
3
|
6
|
6
|
Reasons for withdrawal
| Measure |
Risperidone
12 weeks of randomized treatment with flexibly dosed risperidone
|
Olanzapine
12 weeks of randomized treatment with flexibly dosed olanzapine
|
Aripiprazole
12 weeks of randomized treatment with flexibly dosed aripiprazole
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
3
|
5
|
|
Overall Study
Adverse Event
|
1
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
2
|
1
|
|
Overall Study
Lack of Efficacy
|
0
|
1
|
0
|
Baseline Characteristics
Measure Analysis Population Description: The n's reported here represent complete data only.
Baseline characteristics by cohort
| Measure |
Risperidone
n=49 Participants
12 weeks randomized, flexibly-dosed treatment with risperidone
|
Olanzapine
n=46 Participants
12 weeks randomized, flexibly-dosed treatment with olanzapine
|
Aripiprazole
n=49 Participants
12 weeks randomized, flexibly-dosed treatment with aripiprazole
|
Total
n=144 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
11.32 years
STANDARD_DEVIATION 2.95 • n=49 Participants
|
11.10 years
STANDARD_DEVIATION 2.52 • n=46 Participants
|
11.60 years
STANDARD_DEVIATION 2.92 • n=49 Participants
|
11.35 years
STANDARD_DEVIATION 2.79 • n=144 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=49 Participants
|
18 Participants
n=46 Participants
|
15 Participants
n=49 Participants
|
46 Participants
n=144 Participants
|
|
Sex: Female, Male
Male
|
36 Participants
n=49 Participants
|
28 Participants
n=46 Participants
|
34 Participants
n=49 Participants
|
98 Participants
n=144 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=49 Participants
|
1 Participants
n=46 Participants
|
1 Participants
n=49 Participants
|
4 Participants
n=144 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
47 Participants
n=49 Participants
|
45 Participants
n=46 Participants
|
48 Participants
n=49 Participants
|
140 Participants
n=144 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=49 Participants
|
0 Participants
n=46 Participants
|
0 Participants
n=49 Participants
|
0 Participants
n=144 Participants
|
|
Race/Ethnicity, Customized
White
|
24 participants
n=49 Participants
|
22 participants
n=46 Participants
|
19 participants
n=49 Participants
|
65 participants
n=144 Participants
|
|
Race/Ethnicity, Customized
Non-White
|
25 participants
n=49 Participants
|
24 participants
n=46 Participants
|
30 participants
n=49 Participants
|
79 participants
n=144 Participants
|
|
Primary Diagnosis
Attention Deficit Hyperactivity Disorder
|
28 participants
n=49 Participants
|
23 participants
n=46 Participants
|
29 participants
n=49 Participants
|
80 participants
n=144 Participants
|
|
Primary Diagnosis
Disruptive Behavior Disorder
|
8 participants
n=49 Participants
|
11 participants
n=46 Participants
|
13 participants
n=49 Participants
|
32 participants
n=144 Participants
|
|
Primary Diagnosis
Mood Disorder
|
7 participants
n=49 Participants
|
5 participants
n=46 Participants
|
4 participants
n=49 Participants
|
16 participants
n=144 Participants
|
|
Primary Diagnosis
Autism Spectrum Disorder
|
3 participants
n=49 Participants
|
4 participants
n=46 Participants
|
3 participants
n=49 Participants
|
10 participants
n=144 Participants
|
|
Primary Diagnosis
Psychosis
|
2 participants
n=49 Participants
|
2 participants
n=46 Participants
|
0 participants
n=49 Participants
|
4 participants
n=144 Participants
|
|
Primary Diagnosis
Obsessive Compulsive Disorder
|
0 participants
n=49 Participants
|
1 participants
n=46 Participants
|
0 participants
n=49 Participants
|
1 participants
n=144 Participants
|
|
Primary Diagnosis
Tourette Disorder
|
1 participants
n=49 Participants
|
0 participants
n=46 Participants
|
0 participants
n=49 Participants
|
1 participants
n=144 Participants
|
|
Clinical Global Improvement (CGI)-Severity of Illness
Moderately ill
|
18 participants
n=49 Participants
|
19 participants
n=46 Participants
|
23 participants
n=49 Participants
|
60 participants
n=144 Participants
|
|
Clinical Global Improvement (CGI)-Severity of Illness
Markedly ill
|
31 participants
n=49 Participants
|
26 participants
n=46 Participants
|
23 participants
n=49 Participants
|
80 participants
n=144 Participants
|
|
Clinical Global Improvement (CGI)-Severity of Illness
Severely ill
|
0 participants
n=49 Participants
|
1 participants
n=46 Participants
|
3 participants
n=49 Participants
|
4 participants
n=144 Participants
|
|
Aberrant Behavioral Checklist Subscales
Total
|
88.03 units on a scale
STANDARD_DEVIATION 23.96 • n=49 Participants
|
81.89 units on a scale
STANDARD_DEVIATION 21.55 • n=46 Participants
|
83.53 units on a scale
STANDARD_DEVIATION 25.70 • n=49 Participants
|
84.54 units on a scale
STANDARD_DEVIATION 23.82 • n=144 Participants
|
|
Aberrant Behavioral Checklist Subscales
Irritability/Aggression
|
28.49 units on a scale
STANDARD_DEVIATION 5.53 • n=49 Participants
|
28.17 units on a scale
STANDARD_DEVIATION 5.73 • n=46 Participants
|
28.14 units on a scale
STANDARD_DEVIATION 6.27 • n=49 Participants
|
28.27 units on a scale
STANDARD_DEVIATION 5.81 • n=144 Participants
|
|
Aberrant Behavioral Checklist Subscales
Lethargy
|
16.57 units on a scale
STANDARD_DEVIATION 10.01 • n=49 Participants
|
12.67 units on a scale
STANDARD_DEVIATION 8.15 • n=46 Participants
|
14.61 units on a scale
STANDARD_DEVIATION 8.83 • n=49 Participants
|
14.66 units on a scale
STANDARD_DEVIATION 9.12 • n=144 Participants
|
|
Aberrant Behavioral Checklist Subscales
Stereotypy
|
5.54 units on a scale
STANDARD_DEVIATION 4.95 • n=49 Participants
|
5.15 units on a scale
STANDARD_DEVIATION 4.42 • n=46 Participants
|
4.29 units on a scale
STANDARD_DEVIATION 4.61 • n=49 Participants
|
4.99 units on a scale
STANDARD_DEVIATION 4.67 • n=144 Participants
|
|
Aberrant Behavioral Checklist Subscales
Hyperactivity
|
32.83 units on a scale
STANDARD_DEVIATION 9.68 • n=49 Participants
|
32.11 units on a scale
STANDARD_DEVIATION 10.45 • n=46 Participants
|
32.80 units on a scale
STANDARD_DEVIATION 10.88 • n=49 Participants
|
32.59 units on a scale
STANDARD_DEVIATION 10.28 • n=144 Participants
|
|
Aberrant Behavioral Checklist Subscales
Inappropriate Speech
|
4.60 units on a scale
STANDARD_DEVIATION 3.02 • n=49 Participants
|
3.78 units on a scale
STANDARD_DEVIATION 2.71 • n=46 Participants
|
3.69 units on a scale
STANDARD_DEVIATION 2.76 • n=49 Participants
|
4.03 units on a scale
STANDARD_DEVIATION 2.85 • n=144 Participants
|
|
Clinical Global Assessment of Functioning
|
51.71 units on a scale
STANDARD_DEVIATION 4.44 • n=49 Participants
|
50.67 units on a scale
STANDARD_DEVIATION 5.44 • n=46 Participants
|
50.88 units on a scale
STANDARD_DEVIATION 6.00 • n=49 Participants
|
51.10 units on a scale
STANDARD_DEVIATION 5.31 • n=144 Participants
|
|
Number of Suspensions
|
2.60 number of discrete school suspensions
STANDARD_DEVIATION 4.11 • n=43 Participants • Measure Analysis Population Description: The n's reported here represent complete data only.
|
2.71 number of discrete school suspensions
STANDARD_DEVIATION 3.98 • n=38 Participants • Measure Analysis Population Description: The n's reported here represent complete data only.
|
2.85 number of discrete school suspensions
STANDARD_DEVIATION 4.18 • n=46 Participants • Measure Analysis Population Description: The n's reported here represent complete data only.
|
2.72 number of discrete school suspensions
STANDARD_DEVIATION 4.07 • n=127 Participants • Measure Analysis Population Description: The n's reported here represent complete data only.
|
|
On stimulant
Yes
|
29 participants
n=49 Participants
|
21 participants
n=46 Participants
|
22 participants
n=49 Participants
|
72 participants
n=144 Participants
|
|
On stimulant
No
|
20 participants
n=49 Participants
|
25 participants
n=46 Participants
|
27 participants
n=49 Participants
|
72 participants
n=144 Participants
|
|
On Selective Serotonin Reuptake Inhibitors (SSRI)
Yes
|
8 participants
n=49 Participants
|
5 participants
n=46 Participants
|
4 participants
n=49 Participants
|
17 participants
n=144 Participants
|
|
On Selective Serotonin Reuptake Inhibitors (SSRI)
No
|
41 participants
n=49 Participants
|
41 participants
n=46 Participants
|
45 participants
n=49 Participants
|
127 participants
n=144 Participants
|
|
DEXA-measured body composition (%)
DEXA Total % Fat
|
26.25 percentage of body composition
STANDARD_DEVIATION 10.64 • n=49 Participants
|
24.48 percentage of body composition
STANDARD_DEVIATION 10.19 • n=46 Participants
|
26.23 percentage of body composition
STANDARD_DEVIATION 10.83 • n=49 Participants
|
25.68 percentage of body composition
STANDARD_DEVIATION 10.52 • n=144 Participants
|
|
DEXA-measured body composition (%)
DEXA Total % Lean
|
70.30 percentage of body composition
STANDARD_DEVIATION 10.35 • n=49 Participants
|
71.96 percentage of body composition
STANDARD_DEVIATION 9.96 • n=46 Participants
|
70.32 percentage of body composition
STANDARD_DEVIATION 10.53 • n=49 Participants
|
70.84 percentage of body composition
STANDARD_DEVIATION 10.25 • n=144 Participants
|
|
DEXA-measured body composition (kg)
DEXA Total Fat kg
|
12.50 kilograms
STANDARD_DEVIATION 9.53 • n=49 Participants
|
10.46 kilograms
STANDARD_DEVIATION 6.68 • n=46 Participants
|
13.24 kilograms
STANDARD_DEVIATION 10.40 • n=49 Participants
|
12.10 kilograms
STANDARD_DEVIATION 9.07 • n=144 Participants
|
|
DEXA-measured body composition (kg)
DEXA Total Lean kg
|
30.38 kilograms
STANDARD_DEVIATION 11.01 • n=49 Participants
|
29.30 kilograms
STANDARD_DEVIATION 9.83 • n=46 Participants
|
31.98 kilograms
STANDARD_DEVIATION 14.69 • n=49 Participants
|
30.58 kilograms
STANDARD_DEVIATION 12.04 • n=144 Participants
|
|
Baseline Insulin Stimulated % Change in Isotopomer Measurement during Week 0 Clamp
% Change in Glucose Rate of Disappearance
|
166.26 % change during baseline clamp
STANDARD_DEVIATION 78.79 • n=42 Participants • Measure Analysis Population Description: Measure Analysis Population Description: The n's reported here represent complete data only.
|
168.75 % change during baseline clamp
STANDARD_DEVIATION 82.09 • n=34 Participants • Measure Analysis Population Description: Measure Analysis Population Description: The n's reported here represent complete data only.
|
156.49 % change during baseline clamp
STANDARD_DEVIATION 81.14 • n=41 Participants • Measure Analysis Population Description: Measure Analysis Population Description: The n's reported here represent complete data only.
|
163.56 % change during baseline clamp
STANDARD_DEVIATION 80.06 • n=117 Participants • Measure Analysis Population Description: Measure Analysis Population Description: The n's reported here represent complete data only.
|
|
Baseline Insulin Stimulated % Change in Isotopomer Measurement during Week 0 Clamp
% Change in Glucose Rate of Appearance
|
83.19 % change during baseline clamp
STANDARD_DEVIATION 10.94 • n=42 Participants • Measure Analysis Population Description: Measure Analysis Population Description: The n's reported here represent complete data only.
|
82.53 % change during baseline clamp
STANDARD_DEVIATION 9.90 • n=34 Participants • Measure Analysis Population Description: Measure Analysis Population Description: The n's reported here represent complete data only.
|
82.70 % change during baseline clamp
STANDARD_DEVIATION 12.15 • n=41 Participants • Measure Analysis Population Description: Measure Analysis Population Description: The n's reported here represent complete data only.
|
82.83 % change during baseline clamp
STANDARD_DEVIATION 11.01 • n=117 Participants • Measure Analysis Population Description: Measure Analysis Population Description: The n's reported here represent complete data only.
|
|
Baseline Insulin Stimulated % Change in Isotopomer Measurement during Week 0 Clamp
% Change in Glycerol Rate of Appearance
|
55.59 % change during baseline clamp
STANDARD_DEVIATION 13.42 • n=42 Participants • Measure Analysis Population Description: Measure Analysis Population Description: The n's reported here represent complete data only.
|
55.94 % change during baseline clamp
STANDARD_DEVIATION 15.08 • n=34 Participants • Measure Analysis Population Description: Measure Analysis Population Description: The n's reported here represent complete data only.
|
50.46 % change during baseline clamp
STANDARD_DEVIATION 15.04 • n=41 Participants • Measure Analysis Population Description: Measure Analysis Population Description: The n's reported here represent complete data only.
|
53.89 % change during baseline clamp
STANDARD_DEVIATION 14.59 • n=117 Participants • Measure Analysis Population Description: Measure Analysis Population Description: The n's reported here represent complete data only.
|
|
Baseline Insulin Stimulated % Change in Isotopomer Measurement during Week 0 Clamp
Whole Body Sensitivity
|
12.96 % change during baseline clamp
STANDARD_DEVIATION 5.33 • n=47 Participants • Measure Analysis Population Description: Measure Analysis Population Description: The n's reported here represent complete data only.
|
12.53 % change during baseline clamp
STANDARD_DEVIATION 4.47 • n=44 Participants • Measure Analysis Population Description: Measure Analysis Population Description: The n's reported here represent complete data only.
|
12.87 % change during baseline clamp
STANDARD_DEVIATION 6.36 • n=48 Participants • Measure Analysis Population Description: Measure Analysis Population Description: The n's reported here represent complete data only.
|
12.80 % change during baseline clamp
STANDARD_DEVIATION 5.44 • n=139 Participants • Measure Analysis Population Description: Measure Analysis Population Description: The n's reported here represent complete data only.
|
|
MRI-measured abdominal fat
MRI Subcutaneous Fat
|
121.38 cm squared
STANDARD_DEVIATION 123.05 • n=34 Participants • The n's reported here represent complete data only.
|
86.17 cm squared
STANDARD_DEVIATION 65.10 • n=29 Participants • The n's reported here represent complete data only.
|
111.16 cm squared
STANDARD_DEVIATION 94.16 • n=33 Participants • The n's reported here represent complete data only.
|
107.23 cm squared
STANDARD_DEVIATION 98.53 • n=96 Participants • The n's reported here represent complete data only.
|
|
MRI-measured abdominal fat
MRI Visceral Fat
|
25.79 cm squared
STANDARD_DEVIATION 18.45 • n=34 Participants • The n's reported here represent complete data only.
|
19.37 cm squared
STANDARD_DEVIATION 19.74 • n=30 Participants • The n's reported here represent complete data only.
|
26.70 cm squared
STANDARD_DEVIATION 24.14 • n=33 Participants • The n's reported here represent complete data only.
|
24.11 cm squared
STANDARD_DEVIATION 20.96 • n=97 Participants • The n's reported here represent complete data only.
|
|
MRI-measured abdominal fat
MRI Total Fat
|
147.17 cm squared
STANDARD_DEVIATION 137.36 • n=34 Participants • The n's reported here represent complete data only.
|
106.09 cm squared
STANDARD_DEVIATION 82.28 • n=29 Participants • The n's reported here represent complete data only.
|
137.85 cm squared
STANDARD_DEVIATION 116.24 • n=33 Participants • The n's reported here represent complete data only.
|
131.56 cm squared
STANDARD_DEVIATION 115.76 • n=96 Participants • The n's reported here represent complete data only.
|
|
Body Weight
|
45.49 kilograms
STANDARD_DEVIATION 19.08 • n=49 Participants
|
42.23 kilograms
STANDARD_DEVIATION 13.81 • n=46 Participants
|
47.94 kilograms
STANDARD_DEVIATION 23.57 • n=49 Participants
|
45.28 kilograms
STANDARD_DEVIATION 19.34 • n=144 Participants
|
|
Waist Circumference
|
68.72 centimeters
STANDARD_DEVIATION 13.47 • n=49 Participants
|
65.87 centimeters
STANDARD_DEVIATION 11.03 • n=46 Participants
|
69.54 centimeters
STANDARD_DEVIATION 15.50 • n=49 Participants
|
68.09 centimeters
STANDARD_DEVIATION 13.50 • n=144 Participants
|
|
Body Mass Index Percentile
|
62.13 percentile
STANDARD_DEVIATION 29.70 • n=49 Participants
|
58.38 percentile
STANDARD_DEVIATION 31.33 • n=46 Participants
|
63.05 percentile
STANDARD_DEVIATION 30.12 • n=49 Participants
|
61.25 percentile
STANDARD_DEVIATION 30.22 • n=144 Participants
|
|
Body Mass index z-score
|
0.49 z-score
STANDARD_DEVIATION 1.12 • n=49 Participants
|
0.30 z-score
STANDARD_DEVIATION 1.11 • n=46 Participants
|
0.55 z-score
STANDARD_DEVIATION 1.13 • n=49 Participants
|
0.45 z-score
STANDARD_DEVIATION 1.12 • n=144 Participants
|
|
Baseline fasting laboratory values (mg/dL)
Fasting Glucose
|
89.14 mg/dL
STANDARD_DEVIATION 8.81 • n=49 Participants
|
87.48 mg/dL
STANDARD_DEVIATION 6.55 • n=46 Participants
|
88.98 mg/dL
STANDARD_DEVIATION 6.16 • n=49 Participants
|
88.56 mg/dL
STANDARD_DEVIATION 7.27 • n=144 Participants
|
|
Baseline fasting laboratory values (mg/dL)
Total Cholesterol
|
144.74 mg/dL
STANDARD_DEVIATION 28.88 • n=49 Participants
|
137.09 mg/dL
STANDARD_DEVIATION 25.31 • n=46 Participants
|
135.45 mg/dL
STANDARD_DEVIATION 28.34 • n=49 Participants
|
139.14 mg/dL
STANDARD_DEVIATION 27.71 • n=144 Participants
|
|
Baseline fasting laboratory values (mg/dL)
Triglycerides
|
60.40 mg/dL
STANDARD_DEVIATION 33.00 • n=49 Participants
|
60.98 mg/dL
STANDARD_DEVIATION 31.89 • n=46 Participants
|
52.16 mg/dL
STANDARD_DEVIATION 23.13 • n=49 Participants
|
57.78 mg/dL
STANDARD_DEVIATION 29.69 • n=144 Participants
|
|
Baseline fasting laboratory values (mg/dL)
LDL Cholesterol
|
79.53 mg/dL
STANDARD_DEVIATION 25.41 • n=49 Participants
|
72.00 mg/dL
STANDARD_DEVIATION 24.56 • n=46 Participants
|
72.82 mg/dL
STANDARD_DEVIATION 26.00 • n=49 Participants
|
74.84 mg/dL
STANDARD_DEVIATION 25.40 • n=144 Participants
|
|
Baseline fasting laboratory values (mg/dL)
Total Bilirubin
|
0.37 mg/dL
STANDARD_DEVIATION 0.25 • n=49 Participants
|
0.40 mg/dL
STANDARD_DEVIATION 0.18 • n=46 Participants
|
0.33 mg/dL
STANDARD_DEVIATION 0.18 • n=49 Participants
|
0.37 mg/dL
STANDARD_DEVIATION 0.21 • n=144 Participants
|
|
Baseline Fasting Laboratory Values (IU/L)
Alanine aminotransferase (ALT)
|
18.10 IU/L
STANDARD_DEVIATION 7.74 • n=49 Participants
|
13.83 IU/L
STANDARD_DEVIATION 4.20 • n=46 Participants
|
15.53 IU/L
STANDARD_DEVIATION 4.49 • n=49 Participants
|
15.86 IU/L
STANDARD_DEVIATION 5.96 • n=144 Participants
|
|
Baseline Fasting Laboratory Values (IU/L)
Aspartate aminostransferase (AST)
|
25.65 IU/L
STANDARD_DEVIATION 7.10 • n=49 Participants
|
23.26 IU/L
STANDARD_DEVIATION 6.12 • n=46 Participants
|
23.94 IU/L
STANDARD_DEVIATION 6.78 • n=49 Participants
|
24.31 IU/L
STANDARD_DEVIATION 6.72 • n=144 Participants
|
|
Baseline Fasting Laboratory Values (IU/L)
Alkaline Phosphatase
|
209.33 IU/L
STANDARD_DEVIATION 88.42 • n=49 Participants
|
222.54 IU/L
STANDARD_DEVIATION 75.69 • n=46 Participants
|
206.41 IU/L
STANDARD_DEVIATION 85.35 • n=49 Participants
|
212.56 IU/L
STANDARD_DEVIATION 83.19 • n=144 Participants
|
|
Baseline fasting laboratory values (g/dL)
Albumin
|
4.02 g/dL
STANDARD_DEVIATION 0.25 • n=49 Participants
|
4.06 g/dL
STANDARD_DEVIATION 0.27 • n=46 Participants
|
4.05 g/dL
STANDARD_DEVIATION 0.25 • n=49 Participants
|
4.05 g/dL
STANDARD_DEVIATION 0.25 • n=144 Participants
|
|
Baseline fasting laboratory values (g/dL)
Total Protein
|
6.95 g/dL
STANDARD_DEVIATION 0.46 • n=49 Participants
|
6.90 g/dL
STANDARD_DEVIATION 0.39 • n=46 Participants
|
6.95 g/dL
STANDARD_DEVIATION 0.34 • n=49 Participants
|
6.94 g/dL
STANDARD_DEVIATION 0.40 • n=144 Participants
|
|
High Sensitivity c-Reactive Protein (HS-CRP)
|
1.61 mg/L
STANDARD_DEVIATION 3.04 • n=48 Participants • The n's reported here represent complete data only.
|
1.37 mg/L
STANDARD_DEVIATION 3.04 • n=46 Participants • The n's reported here represent complete data only.
|
1.12 mg/L
STANDARD_DEVIATION 1.53 • n=48 Participants • The n's reported here represent complete data only.
|
1.37 mg/L
STANDARD_DEVIATION 2.62 • n=142 Participants • The n's reported here represent complete data only.
|
|
Fasting Insulin
|
7.64 uU/mL
STANDARD_DEVIATION 5.85 • n=45 Participants • The n's reported here represent complete data only.
|
6.24 uU/mL
STANDARD_DEVIATION 3.74 • n=43 Participants • The n's reported here represent complete data only.
|
9.00 uU/mL
STANDARD_DEVIATION 8.68 • n=45 Participants • The n's reported here represent complete data only.
|
7.65 uU/mL
STANDARD_DEVIATION 6.50 • n=133 Participants • The n's reported here represent complete data only.
|
|
Hemoglobin A1c
|
5.46 %
STANDARD_DEVIATION 0.26 • n=49 Participants
|
5.54 %
STANDARD_DEVIATION 0.34 • n=46 Participants
|
5.54 %
STANDARD_DEVIATION 0.28 • n=49 Participants
|
5.52 %
STANDARD_DEVIATION 0.29 • n=144 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: Modified Intent to Treat (ITT) sample with week 0 and week 12 data.
This study hypothesized that antipsychotic treatment would increase percent total body fat, as measured by whole body dual energy x-ray absorptiometry (DEXA), with larger adverse effects for olanzapine.
Outcome measures
| Measure |
Risperidone
n=46 Participants
12 weeks randomized, flexibly-dosed treatment with risperidone
|
Olanzapine
n=40 Participants
12 weeks randomized, flexibly-dosed treatment with olanzapine
|
Aripiprazole
n=42 Participants
12 weeks randomized, flexibly-dosed treatment with aripiprazole
|
|---|---|---|---|
|
Change in DEXA % Body Fat
|
1.81 percent body fat
Standard Deviation 3.11
|
4.12 percent body fat
Standard Deviation 3.10
|
1.66 percent body fat
Standard Deviation 2.65
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: Children ages 6-18 with a Diagnostic and Statistical Manual Text Revision (DSM-IV-TR) diagnosis and clinically significant aggression or irritability
This study hypothesized that antipsychotic treatment would decrease insulin sensitivity at muscle, as measured by the insulin-stimulated rate of disappearance of glucose (glucose Rd), with larger adverse effects for olanzapine.
Outcome measures
| Measure |
Risperidone
n=39 Participants
12 weeks randomized, flexibly-dosed treatment with risperidone
|
Olanzapine
n=33 Participants
12 weeks randomized, flexibly-dosed treatment with olanzapine
|
Aripiprazole
n=40 Participants
12 weeks randomized, flexibly-dosed treatment with aripiprazole
|
|---|---|---|---|
|
Change in Insulin-stimulated Glucose Rate of Disappearance (Glucose Rd)
|
2.30 percentage of % change
Standard Deviation 83.91
|
-29.34 percentage of % change
Standard Deviation 85.56
|
-30.26 percentage of % change
Standard Deviation 65.46
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Modified Intent to Treat (ITT) sample with week 0 and week 12 data.
This study hypothesized that antipsychotic treatment would decrease insulin sensitivity at adipose tissue, as measured by the insulin-stimulated rate of disappearance of glycerol (glycerol Ra), with larger adverse effects for olanzapine.
Outcome measures
| Measure |
Risperidone
n=38 Participants
12 weeks randomized, flexibly-dosed treatment with risperidone
|
Olanzapine
n=31 Participants
12 weeks randomized, flexibly-dosed treatment with olanzapine
|
Aripiprazole
n=39 Participants
12 weeks randomized, flexibly-dosed treatment with aripiprazole
|
|---|---|---|---|
|
Change in Insulin-stimulated Glycerol Rate of Appearance (Glycerol Ra)
|
-3.65 percentage of % change
Standard Deviation 17.23
|
-8.29 percentage of % change
Standard Deviation 22.39
|
1.70 percentage of % change
Standard Deviation 16.79
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Modified Intent to Treat (ITT) sample with week 0 and week 12 data.
This study hypothesized that antipsychotic treatment would decrease hepatic insulin sensitivity, as measured by the rate of appearance of glucose (glucose Ra), with larger adverse effects for olanzapine.
Outcome measures
| Measure |
Risperidone
n=39 Participants
12 weeks randomized, flexibly-dosed treatment with risperidone
|
Olanzapine
n=33 Participants
12 weeks randomized, flexibly-dosed treatment with olanzapine
|
Aripiprazole
n=40 Participants
12 weeks randomized, flexibly-dosed treatment with aripiprazole
|
|---|---|---|---|
|
Change in Insulin-stimulated Glucose Rate of Appearance (Glucose Ra)
|
-2.50 percentage of % change
Standard Deviation 7.61
|
-6.57 percentage of % change
Standard Deviation 13.16
|
-3.27 percentage of % change
Standard Deviation 9.27
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Modified Intent to Treat (ITT) sample with week 0 and week 12 data.
This study hypothesized that antipsychotic treatment would increase visceral abdominal fat, as measured by abdominal magnetic resonance imaging (MRI), with larger adverse effects for olanzapine.
Outcome measures
| Measure |
Risperidone
n=30 Participants
12 weeks randomized, flexibly-dosed treatment with risperidone
|
Olanzapine
n=26 Participants
12 weeks randomized, flexibly-dosed treatment with olanzapine
|
Aripiprazole
n=30 Participants
12 weeks randomized, flexibly-dosed treatment with aripiprazole
|
|---|---|---|---|
|
Change in MRI-measured Visceral Abdominal Fat
|
6.85 Change in cm-squared
Standard Deviation 10.99
|
10.73 Change in cm-squared
Standard Deviation 14.50
|
12.04 Change in cm-squared
Standard Deviation 15.11
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Modified Intent to Treat (ITT) sample with week 0 and week 12 data.
This study hypothesized that antipsychotic treatment would increase subcutaneous abdominal fat, as measured by abdominal magnetic resonance imaging (MRI), with larger adverse effects for olanzapine.
Outcome measures
| Measure |
Risperidone
n=30 Participants
12 weeks randomized, flexibly-dosed treatment with risperidone
|
Olanzapine
n=26 Participants
12 weeks randomized, flexibly-dosed treatment with olanzapine
|
Aripiprazole
n=30 Participants
12 weeks randomized, flexibly-dosed treatment with aripiprazole
|
|---|---|---|---|
|
Change in MRI-measured Subcutaneous Abdominal Fat
|
18.21 Change in cm-squared
Standard Deviation 22.27
|
34.27 Change in cm-squared
Standard Deviation 27.22
|
15.84 Change in cm-squared
Standard Deviation 19.02
|
Adverse Events
Aripiprazole
Serious events: 0 serious events
Other events: 38 other events
Deaths: 0 deaths
Olanzapine
Serious events: 0 serious events
Other events: 38 other events
Deaths: 0 deaths
Risperidone
Serious events: 1 serious events
Other events: 39 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Aripiprazole
n=49 participants at risk
Participants in this group were randomized to treatment with aripiprazole.
|
Olanzapine
n=46 participants at risk
Participants in this group were randomized to treatment with olanzapine.
|
Risperidone
n=49 participants at risk
Participants in this group were randomized to treatment with risperidone.
|
|---|---|---|---|
|
Nervous system disorders
Seizure
|
0.00%
0/49 • Adverse events were collected throughout the entire course of the study, April 2006 to July 2011 or 6 years and 3 months
|
0.00%
0/46 • Adverse events were collected throughout the entire course of the study, April 2006 to July 2011 or 6 years and 3 months
|
2.0%
1/49 • Number of events 1 • Adverse events were collected throughout the entire course of the study, April 2006 to July 2011 or 6 years and 3 months
|
Other adverse events
| Measure |
Aripiprazole
n=49 participants at risk
Participants in this group were randomized to treatment with aripiprazole.
|
Olanzapine
n=46 participants at risk
Participants in this group were randomized to treatment with olanzapine.
|
Risperidone
n=49 participants at risk
Participants in this group were randomized to treatment with risperidone.
|
|---|---|---|---|
|
Psychiatric disorders
Accidental Injury
|
6.1%
3/49 • Adverse events were collected throughout the entire course of the study, April 2006 to July 2011 or 6 years and 3 months
|
6.5%
3/46 • Adverse events were collected throughout the entire course of the study, April 2006 to July 2011 or 6 years and 3 months
|
10.2%
5/49 • Adverse events were collected throughout the entire course of the study, April 2006 to July 2011 or 6 years and 3 months
|
|
Psychiatric disorders
Agitation
|
30.6%
15/49 • Adverse events were collected throughout the entire course of the study, April 2006 to July 2011 or 6 years and 3 months
|
45.7%
21/46 • Adverse events were collected throughout the entire course of the study, April 2006 to July 2011 or 6 years and 3 months
|
32.7%
16/49 • Adverse events were collected throughout the entire course of the study, April 2006 to July 2011 or 6 years and 3 months
|
|
Psychiatric disorders
Anxiety
|
18.4%
9/49 • Adverse events were collected throughout the entire course of the study, April 2006 to July 2011 or 6 years and 3 months
|
21.7%
10/46 • Adverse events were collected throughout the entire course of the study, April 2006 to July 2011 or 6 years and 3 months
|
26.5%
13/49 • Adverse events were collected throughout the entire course of the study, April 2006 to July 2011 or 6 years and 3 months
|
|
Psychiatric disorders
Constipation
|
2.0%
1/49 • Adverse events were collected throughout the entire course of the study, April 2006 to July 2011 or 6 years and 3 months
|
4.3%
2/46 • Adverse events were collected throughout the entire course of the study, April 2006 to July 2011 or 6 years and 3 months
|
14.3%
7/49 • Adverse events were collected throughout the entire course of the study, April 2006 to July 2011 or 6 years and 3 months
|
|
Psychiatric disorders
Depression
|
2.0%
1/49 • Adverse events were collected throughout the entire course of the study, April 2006 to July 2011 or 6 years and 3 months
|
10.9%
5/46 • Adverse events were collected throughout the entire course of the study, April 2006 to July 2011 or 6 years and 3 months
|
8.2%
4/49 • Adverse events were collected throughout the entire course of the study, April 2006 to July 2011 or 6 years and 3 months
|
|
Psychiatric disorders
Difficulty Concentrating
|
20.4%
10/49 • Adverse events were collected throughout the entire course of the study, April 2006 to July 2011 or 6 years and 3 months
|
26.1%
12/46 • Adverse events were collected throughout the entire course of the study, April 2006 to July 2011 or 6 years and 3 months
|
32.7%
16/49 • Adverse events were collected throughout the entire course of the study, April 2006 to July 2011 or 6 years and 3 months
|
|
Psychiatric disorders
Drowsiness/Somnolence
|
22.4%
11/49 • Adverse events were collected throughout the entire course of the study, April 2006 to July 2011 or 6 years and 3 months
|
21.7%
10/46 • Adverse events were collected throughout the entire course of the study, April 2006 to July 2011 or 6 years and 3 months
|
16.3%
8/49 • Adverse events were collected throughout the entire course of the study, April 2006 to July 2011 or 6 years and 3 months
|
|
Psychiatric disorders
Headache
|
8.2%
4/49 • Adverse events were collected throughout the entire course of the study, April 2006 to July 2011 or 6 years and 3 months
|
8.7%
4/46 • Adverse events were collected throughout the entire course of the study, April 2006 to July 2011 or 6 years and 3 months
|
10.2%
5/49 • Adverse events were collected throughout the entire course of the study, April 2006 to July 2011 or 6 years and 3 months
|
|
Psychiatric disorders
Increased Appetite
|
36.7%
18/49 • Adverse events were collected throughout the entire course of the study, April 2006 to July 2011 or 6 years and 3 months
|
67.4%
31/46 • Adverse events were collected throughout the entire course of the study, April 2006 to July 2011 or 6 years and 3 months
|
30.6%
15/49 • Adverse events were collected throughout the entire course of the study, April 2006 to July 2011 or 6 years and 3 months
|
|
Psychiatric disorders
Involuntary Movements
|
0.00%
0/49 • Adverse events were collected throughout the entire course of the study, April 2006 to July 2011 or 6 years and 3 months
|
2.2%
1/46 • Adverse events were collected throughout the entire course of the study, April 2006 to July 2011 or 6 years and 3 months
|
8.2%
4/49 • Adverse events were collected throughout the entire course of the study, April 2006 to July 2011 or 6 years and 3 months
|
|
Psychiatric disorders
Restlessness
|
24.5%
12/49 • Adverse events were collected throughout the entire course of the study, April 2006 to July 2011 or 6 years and 3 months
|
26.1%
12/46 • Adverse events were collected throughout the entire course of the study, April 2006 to July 2011 or 6 years and 3 months
|
28.6%
14/49 • Adverse events were collected throughout the entire course of the study, April 2006 to July 2011 or 6 years and 3 months
|
|
Psychiatric disorders
Runny Nose
|
12.2%
6/49 • Adverse events were collected throughout the entire course of the study, April 2006 to July 2011 or 6 years and 3 months
|
2.2%
1/46 • Adverse events were collected throughout the entire course of the study, April 2006 to July 2011 or 6 years and 3 months
|
2.0%
1/49 • Adverse events were collected throughout the entire course of the study, April 2006 to July 2011 or 6 years and 3 months
|
|
Psychiatric disorders
Sleepiness
|
10.2%
5/49 • Adverse events were collected throughout the entire course of the study, April 2006 to July 2011 or 6 years and 3 months
|
19.6%
9/46 • Adverse events were collected throughout the entire course of the study, April 2006 to July 2011 or 6 years and 3 months
|
8.2%
4/49 • Adverse events were collected throughout the entire course of the study, April 2006 to July 2011 or 6 years and 3 months
|
|
Psychiatric disorders
Thirst
|
2.0%
1/49 • Adverse events were collected throughout the entire course of the study, April 2006 to July 2011 or 6 years and 3 months
|
6.5%
3/46 • Adverse events were collected throughout the entire course of the study, April 2006 to July 2011 or 6 years and 3 months
|
2.0%
1/49 • Adverse events were collected throughout the entire course of the study, April 2006 to July 2011 or 6 years and 3 months
|
|
Psychiatric disorders
Tiredness/Fatigue
|
12.2%
6/49 • Adverse events were collected throughout the entire course of the study, April 2006 to July 2011 or 6 years and 3 months
|
13.0%
6/46 • Adverse events were collected throughout the entire course of the study, April 2006 to July 2011 or 6 years and 3 months
|
4.1%
2/49 • Adverse events were collected throughout the entire course of the study, April 2006 to July 2011 or 6 years and 3 months
|
|
Psychiatric disorders
Trouble Sleeping
|
8.2%
4/49 • Adverse events were collected throughout the entire course of the study, April 2006 to July 2011 or 6 years and 3 months
|
6.5%
3/46 • Adverse events were collected throughout the entire course of the study, April 2006 to July 2011 or 6 years and 3 months
|
16.3%
8/49 • Adverse events were collected throughout the entire course of the study, April 2006 to July 2011 or 6 years and 3 months
|
|
Psychiatric disorders
Weight Gain
|
22.4%
11/49 • Adverse events were collected throughout the entire course of the study, April 2006 to July 2011 or 6 years and 3 months
|
50.0%
23/46 • Adverse events were collected throughout the entire course of the study, April 2006 to July 2011 or 6 years and 3 months
|
40.8%
20/49 • Adverse events were collected throughout the entire course of the study, April 2006 to July 2011 or 6 years and 3 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place