Trial Outcomes & Findings for Biomarkers of Cardiometabolic Risk in Children Treated With Antipsychotics: A Preliminary Study of Direct Measures (NCT NCT00894738)
NCT ID: NCT00894738
Last Updated: 2019-06-06
Results Overview
Recruitment status
COMPLETED
Target enrollment
44 participants
Primary outcome timeframe
Week 1
Results posted on
2019-06-06
Participant Flow
Participant milestones
| Measure |
Antipsychotic-Treated
Children with psychiatric diagnoses who are currently treated with antipsychotic medications.
|
Healthy Control
Age- and gender-matched children who do not have a psychiatric diagnosis, are not taking antipsychotic medications, and are otherwise healthy.
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
19
|
|
Overall Study
COMPLETED
|
25
|
19
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
1 participant is missing a CIMT.
Baseline characteristics by cohort
| Measure |
Antipsychotic-Treated
n=25 Participants
Children with psychiatric diagnoses who are currently treated with antipsychotic medications.
|
Healthy Control
n=19 Participants
Age- and gender-matched children who do not have a psychiatric diagnosis, are not taking antipsychotic medications, and are otherwise healthy.
|
Total
n=44 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
Pre-pubertal status, ages 6-11
|
10.3 years
STANDARD_DEVIATION 1.5 • n=25 Participants
|
9.5 years
STANDARD_DEVIATION 1.6 • n=19 Participants
|
9.9 years
STANDARD_DEVIATION 1.6 • n=44 Participants
|
|
Age, Continuous
Post-pubertal status, age 12-19
|
14.7 years
STANDARD_DEVIATION 1.7 • n=25 Participants
|
15.3 years
STANDARD_DEVIATION 1.0 • n=19 Participants
|
15.0 years
STANDARD_DEVIATION 1.4 • n=44 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=25 Participants
|
4 Participants
n=19 Participants
|
10 Participants
n=44 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=25 Participants
|
15 Participants
n=19 Participants
|
34 Participants
n=44 Participants
|
|
Race/Ethnicity, Customized
White
|
9 Participants
n=25 Participants
|
13 Participants
n=19 Participants
|
22 Participants
n=44 Participants
|
|
Race/Ethnicity, Customized
Not White
|
16 Participants
n=25 Participants
|
6 Participants
n=19 Participants
|
22 Participants
n=44 Participants
|
|
Body Mass Index (BMI) Percentile
|
67.5 Percentile
STANDARD_DEVIATION 28.4 • n=25 Participants
|
58.9 Percentile
STANDARD_DEVIATION 30.2 • n=19 Participants
|
63.8 Percentile
STANDARD_DEVIATION 29.2 • n=44 Participants
|
|
Blood Pressure
Systolic
|
111 mm Hg
STANDARD_DEVIATION 9 • n=25 Participants
|
112 mm Hg
STANDARD_DEVIATION 13 • n=19 Participants
|
111 mm Hg
STANDARD_DEVIATION 11 • n=44 Participants
|
|
Blood Pressure
Diastolic
|
69 mm Hg
STANDARD_DEVIATION 6 • n=25 Participants
|
67 mm Hg
STANDARD_DEVIATION 8 • n=19 Participants
|
68 mm Hg
STANDARD_DEVIATION 7 • n=44 Participants
|
|
Dual Energy X-ray Absorptiometry (DEXA) Total Percent Fat
|
26.3 percent of total body fat
STANDARD_DEVIATION 11.1 • n=25 Participants
|
24.1 percent of total body fat
STANDARD_DEVIATION 11.4 • n=19 Participants
|
25.3 percent of total body fat
STANDARD_DEVIATION 11.2 • n=44 Participants
|
|
Carotid Intima Media Thickness (CIMT)
|
0.51 mm
STANDARD_DEVIATION 0.05 • n=24 Participants • 1 participant is missing a CIMT.
|
0.52 mm
STANDARD_DEVIATION 0.05 • n=19 Participants • 1 participant is missing a CIMT.
|
0.51 mm
STANDARD_DEVIATION 0.05 • n=43 Participants • 1 participant is missing a CIMT.
|
|
Intrahepatic Triglyceride Content (IHTG)
|
2.5 percent of liver fat
STANDARD_DEVIATION 3.0 • n=24 Participants • 1 participant is missing a IHTG.
|
1.6 percent of liver fat
STANDARD_DEVIATION 1.4 • n=19 Participants • 1 participant is missing a IHTG.
|
2.1 percent of liver fat
STANDARD_DEVIATION 2.5 • n=43 Participants • 1 participant is missing a IHTG.
|
|
Vitamin D Level
|
18.4 ng/mL
STANDARD_DEVIATION 5.4 • n=25 Participants
|
22.1 ng/mL
STANDARD_DEVIATION 7.1 • n=19 Participants
|
20.0 ng/mL
STANDARD_DEVIATION 6.4 • n=44 Participants
|
|
Fasting Glucose
|
88.0 mg/dL
STANDARD_DEVIATION 8.1 • n=25 Participants
|
87.2 mg/dL
STANDARD_DEVIATION 7.3 • n=19 Participants
|
87.7 mg/dL
STANDARD_DEVIATION 7.7 • n=44 Participants
|
|
Fasting Insulin
|
15.5 uIU/mL
STANDARD_DEVIATION 16.8 • n=25 Participants
|
11.0 uIU/mL
STANDARD_DEVIATION 5.8 • n=19 Participants
|
13.5 uIU/mL
STANDARD_DEVIATION 13.3 • n=44 Participants
|
|
Fasting Lipids
Total Cholesterol
|
164.2 mg/dL
STANDARD_DEVIATION 24.9 • n=25 Participants
|
149.7 mg/dL
STANDARD_DEVIATION 25.5 • n=19 Participants
|
158.0 mg/dL
STANDARD_DEVIATION 25.9 • n=44 Participants
|
|
Fasting Lipids
High Density Lipoprotein (HDL) Cholesterol
|
57.1 mg/dL
STANDARD_DEVIATION 12.7 • n=25 Participants
|
54.1 mg/dL
STANDARD_DEVIATION 15.2 • n=19 Participants
|
55.8 mg/dL
STANDARD_DEVIATION 13.7 • n=44 Participants
|
|
Fasting Lipids
Triglycerides
|
68.6 mg/dL
STANDARD_DEVIATION 40.7 • n=25 Participants
|
68.8 mg/dL
STANDARD_DEVIATION 24.7 • n=19 Participants
|
68.7 mg/dL
STANDARD_DEVIATION 34.3 • n=44 Participants
|
|
Fasting Lipids
Low Density Lipoprotein (LDL) Cholesterol
|
93.4 mg/dL
STANDARD_DEVIATION 19.1 • n=25 Participants
|
81.7 mg/dL
STANDARD_DEVIATION 20.1 • n=19 Participants
|
88.3 mg/dL
STANDARD_DEVIATION 20.1 • n=44 Participants
|
|
High Sensitivity C-Reactive Protein (hsCRP)
|
1.52 mg/L
STANDARD_DEVIATION 3.20 • n=24 Participants • 1 participant is missing a hs-CRP.
|
0.77 mg/L
STANDARD_DEVIATION 1.02 • n=19 Participants • 1 participant is missing a hs-CRP.
|
1.19 mg/L
STANDARD_DEVIATION 2.49 • n=43 Participants • 1 participant is missing a hs-CRP.
|
|
Total Protein
|
7.4 g/dL
STANDARD_DEVIATION 0.5 • n=25 Participants
|
7.1 g/dL
STANDARD_DEVIATION 0.5 • n=19 Participants
|
7.2 g/dL
STANDARD_DEVIATION 0.5 • n=44 Participants
|
|
Albumin
|
4.4 g/dL
STANDARD_DEVIATION 0.3 • n=25 Participants
|
4.4 g/dL
STANDARD_DEVIATION 0.2 • n=19 Participants
|
4.4 g/dL
STANDARD_DEVIATION 0.3 • n=44 Participants
|
|
Alkaline Phosphatase
|
220.3 IU/L
STANDARD_DEVIATION 67.8 • n=24 Participants • 1 participant is missing a Alkaline Phosphatase measure.
|
234.1 IU/L
STANDARD_DEVIATION 106.5 • n=19 Participants • 1 participant is missing a Alkaline Phosphatase measure.
|
226.3 IU/L
STANDARD_DEVIATION 86.2 • n=43 Participants • 1 participant is missing a Alkaline Phosphatase measure.
|
|
Alanine Aminotransferase (ALT)
|
20.5 IU/L
STANDARD_DEVIATION 7.1 • n=24 Participants • 1 participant is missing an ALT.
|
18.9 IU/L
STANDARD_DEVIATION 6.6 • n=19 Participants • 1 participant is missing an ALT.
|
19.8 IU/L
STANDARD_DEVIATION 6.8 • n=43 Participants • 1 participant is missing an ALT.
|
|
Aspartate Aminotransferase (AST)
|
29.0 IU/L
STANDARD_DEVIATION 6.0 • n=24 Participants • 1 participant is missing an AST value.
|
31.4 IU/L
STANDARD_DEVIATION 10.5 • n=19 Participants • 1 participant is missing an AST value.
|
30.0 IU/L
STANDARD_DEVIATION 8.3 • n=43 Participants • 1 participant is missing an AST value.
|
|
Total Bilirubin
|
0.35 mg/dL
STANDARD_DEVIATION 0.16 • n=25 Participants
|
0.50 mg/dL
STANDARD_DEVIATION 0.52 • n=19 Participants
|
0.41 mg/dL
STANDARD_DEVIATION 0.37 • n=44 Participants
|
|
Fibrinogen
|
301.3 mg/dL
STANDARD_DEVIATION 72.7 • n=25 Participants • 1 participant is missing a Fibrinogen.
|
269.0 mg/dL
STANDARD_DEVIATION 45.0 • n=18 Participants • 1 participant is missing a Fibrinogen.
|
287.8 mg/dL
STANDARD_DEVIATION 64.0 • n=43 Participants • 1 participant is missing a Fibrinogen.
|
PRIMARY outcome
Timeframe: Week 1Outcome measures
| Measure |
Antipsychotic-Treated
n=24 Participants
Children with psychiatric diagnoses who are currently treated with antipsychotic medications.
|
Healthy Control
n=19 Participants
Age- and gender-matched children who do not have a psychiatric diagnosis, are not taking antipsychotic medications, and are otherwise healthy.
|
|---|---|---|
|
Carotid Artery Intima-media Thickness Measured by Ultrasonography.
|
0.508 millimeters
Standard Deviation 0.053
|
0.519 millimeters
Standard Deviation 0.048
|
PRIMARY outcome
Timeframe: Week 1Outcome measures
| Measure |
Antipsychotic-Treated
n=24 Participants
Children with psychiatric diagnoses who are currently treated with antipsychotic medications.
|
Healthy Control
n=19 Participants
Age- and gender-matched children who do not have a psychiatric diagnosis, are not taking antipsychotic medications, and are otherwise healthy.
|
|---|---|---|
|
Intrahepatic Triglyceride Content (IHTG) Measure by Liver Magnetic Resonance Spectroscopy.
|
2.48 percent
Standard Deviation 3.03
|
1.57 percent
Standard Deviation 1.37
|
Adverse Events
Antipsychotic-Treated
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Healthy Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Ginger Nicol
Washington University School of Medicine
Phone: (314) 362-2461
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place