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Treatment of Overweight Induced by Antipsychotic Medication in Young People With Autism Spectrum Disorders (ASD) (MET)

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ClinicalTrials.gov Identifier: NCT01825798
Recruitment Status : Completed
First Posted : April 8, 2013
Results First Posted : February 22, 2018
Last Update Posted : February 22, 2018
Sponsor:
Collaborators:
Massachusetts General Hospital
Vanderbilt University
University of Pittsburgh
Nationwide Children's Hospital
Ohio State University
Information provided by (Responsible Party):
Evdokia Anagnostou, Anagnostou, Evdokia, M.D.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Overweight
Autism Spectrum Disorder
Interventions Drug: Metformin
Drug: Placebo
Enrollment 60
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo Hydrochloride Oral Solution Metformin
Hide Arm/Group Description Placebo: The placebo hydrochloride oral solution will be prepared to match the appearance, smell and taste of the metformin as closely as possible. For children from 6-9 years of age, placebo will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if placebo is well-tolerated, the dose will be increased to 500 mg twice daily. For children from 10-17 years of age, placebo will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if placebo is well-tolerated, the dose will be increased to 500 mg twice daily. At the Week 4 visit, if placebo is well-tolerated, the dose will be increased to 850 mg twice daily. Metformin: Metformin will be dispensed in a liquid suspension of 100 mg/mL. For children 6-9 years of age, metformin will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if metformin is well-tolerated, the dose will be increased to 500 mg twice daily. For children from 10-17 years of age, metformin will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if metformin is well-tolerated, the dose will be increased to 500 mg twice daily. At the Week 4 visit, if metformin is well-tolerated, the dose will be increased to 850 mg twice daily.
Period Title: Overall Study
Started 32 28
Completed 30 23
Not Completed 2 5
Reason Not Completed
Adverse Event             1             5
Lost to Follow-up             1             0
Arm/Group Title Placebo Hydrochloride Oral Solution Metformin Total
Hide Arm/Group Description Placebo: The placebo hydrochloride oral solution will be prepared to match the appearance, smell and taste of the metformin as closely as possible. For children from 6-9 years of age, placebo will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if placebo is well-tolerated, the dose will be increased to 500 mg twice daily. For children from 10-17 years of age, placebo will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if placebo is well-tolerated, the dose will be increased to 500 mg twice daily. At the Week 4 visit, if placebo is well-tolerated, the dose will be increased to 850 mg twice daily. Metformin: Metformin will be dispensed in a liquid suspension of 100 mg/mL. For children 6-9 years of age, metformin will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if metformin is well-tolerated, the dose will be increased to 500 mg twice daily. For children from 10-17 years of age, metformin will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if metformin is well-tolerated, the dose will be increased to 500 mg twice daily. At the Week 4 visit, if metformin is well-tolerated, the dose will be increased to 850 mg twice daily. Total of all reporting groups
Overall Number of Baseline Participants 32 28 60
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 32 participants 28 participants 60 participants
<=18 years
32
 100.0%
28
 100.0%
60
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 32 participants 28 participants 60 participants
12.7  (2.64) 12.9  (2.85) 12.8  (2.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 32 participants 28 participants 60 participants
Female
8
  25.0%
7
  25.0%
15
  25.0%
Male
24
  75.0%
21
  75.0%
45
  75.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 32 participants 28 participants 60 participants
Hispanic or Latino
2
   6.3%
0
   0.0%
2
   3.3%
Not Hispanic or Latino
29
  90.6%
28
 100.0%
57
  95.0%
Unknown or Not Reported
1
   3.1%
0
   0.0%
1
   1.7%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 32 participants 28 participants 60 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
2
   6.3%
2
   7.1%
4
   6.7%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
1
   3.1%
3
  10.7%
4
   6.7%
White
28
  87.5%
22
  78.6%
50
  83.3%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
1
   3.1%
1
   3.6%
2
   3.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 32 participants 28 participants 60 participants
Canada 8 8 16
United States 24 20 44
1.Primary Outcome
Title Change in Body Mass Index Z-score
Hide Description [Not Specified]
Time Frame Baseline, 16 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Hydrochloride Oral Solution Metformin
Hide Arm/Group Description:
Placebo: The placebo hydrochloride oral solution will be prepared to match the appearance, smell and taste of the metformin as closely as possible. For children from 6-9 years of age, placebo will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if placebo is well-tolerated, the dose will be increased to 500 mg twice daily. For children from 10-17 years of age, placebo will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if placebo is well-tolerated, the dose will be increased to 500 mg twice daily. At the Week 4 visit, if placebo is well-tolerated, the dose will be increased to 850 mg twice daily.
Metformin: Metformin will be dispensed in a liquid suspension of 100 mg/mL. For children 6-9 years of age, metformin will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if metformin is well-tolerated, the dose will be increased to 500 mg twice daily. For children from 10-17 years of age, metformin will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if metformin is well-tolerated, the dose will be increased to 500 mg twice daily. At the Week 4 visit, if metformin is well-tolerated, the dose will be increased to 850 mg twice daily.
Overall Number of Participants Analyzed 32 28
Mean (95% Confidence Interval)
Unit of Measure: 16-wk change in BMI z-score
0.02
(-0.03 to 0.06)
-0.08
(-0.13 to -0.04)
2.Secondary Outcome
Title Changes in Additional Body Composition Parameters (Absolute Change in Weight)
Hide Description [Not Specified]
Time Frame Baseline, 16 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Hydrochloride Oral Solution Metformin
Hide Arm/Group Description:
Placebo: The placebo hydrochloride oral solution will be prepared to match the appearance, smell and taste of the metformin as closely as possible. For children from 6-9 years of age, placebo will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if placebo is well-tolerated, the dose will be increased to 500 mg twice daily. For children from 10-17 years of age, placebo will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if placebo is well-tolerated, the dose will be increased to 500 mg twice daily. At the Week 4 visit, if placebo is well-tolerated, the dose will be increased to 850 mg twice daily.
Metformin: Metformin will be dispensed in a liquid suspension of 100 mg/mL. For children 6-9 years of age, metformin will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if metformin is well-tolerated, the dose will be increased to 500 mg twice daily. For children from 10-17 years of age, metformin will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if metformin is well-tolerated, the dose will be increased to 500 mg twice daily. At the Week 4 visit, if metformin is well-tolerated, the dose will be increased to 850 mg twice daily.
Overall Number of Participants Analyzed 32 28
Mean (95% Confidence Interval)
Unit of Measure: 16-wk change in weight (kg)
2.80
(1.90 to 3.70)
0.07
(-0.88 to 1.02)
3.Secondary Outcome
Title Changes in Additional Body Composition Parameters (Relative Change in Weight)
Hide Description [Not Specified]
Time Frame Baseline, 16 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Hydrochloride Oral Solution Metformin
Hide Arm/Group Description:
Placebo: The placebo hydrochloride oral solution will be prepared to match the appearance, smell and taste of the metformin as closely as possible. For children from 6-9 years of age, placebo will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if placebo is well-tolerated, the dose will be increased to 500 mg twice daily. For children from 10-17 years of age, placebo will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if placebo is well-tolerated, the dose will be increased to 500 mg twice daily. At the Week 4 visit, if placebo is well-tolerated, the dose will be increased to 850 mg twice daily.
Metformin: Metformin will be dispensed in a liquid suspension of 100 mg/mL. For children 6-9 years of age, metformin will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if metformin is well-tolerated, the dose will be increased to 500 mg twice daily. For children from 10-17 years of age, metformin will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if metformin is well-tolerated, the dose will be increased to 500 mg twice daily. At the Week 4 visit, if metformin is well-tolerated, the dose will be increased to 850 mg twice daily.
Overall Number of Participants Analyzed 32 28
Mean (95% Confidence Interval)
Unit of Measure: 16-wk change in weight (z-score)
0.04
(-0.01 to 0.08)
-0.10
(-0.15 to -0.05)
4.Secondary Outcome
Title Changes in Additional Body Composition Parameters (Absolute BMI)
Hide Description [Not Specified]
Time Frame Baseline, 16 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Hydrochloride Oral Solution Metformin
Hide Arm/Group Description:
Placebo: The placebo hydrochloride oral solution will be prepared to match the appearance, smell and taste of the metformin as closely as possible. For children from 6-9 years of age, placebo will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if placebo is well-tolerated, the dose will be increased to 500 mg twice daily. For children from 10-17 years of age, placebo will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if placebo is well-tolerated, the dose will be increased to 500 mg twice daily. At the Week 4 visit, if placebo is well-tolerated, the dose will be increased to 850 mg twice daily.
Metformin: Metformin will be dispensed in a liquid suspension of 100 mg/mL. For children 6-9 years of age, metformin will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if metformin is well-tolerated, the dose will be increased to 500 mg twice daily. For children from 10-17 years of age, metformin will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if metformin is well-tolerated, the dose will be increased to 500 mg twice daily. At the Week 4 visit, if metformin is well-tolerated, the dose will be increased to 850 mg twice daily.
Overall Number of Participants Analyzed 32 28
Mean (95% Confidence Interval)
Unit of Measure: 16-wk change in BMI (kg/m2)
0.52
(0.18 to 0.87)
-0.43
(-0.80 to -0.06)
5.Secondary Outcome
Title Changes in Additional Body Composition Parameters (Abdominal Circumference)
Hide Description [Not Specified]
Time Frame Baseline, 16 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Hydrochloride Oral Solution Metformin
Hide Arm/Group Description:
Placebo: The placebo hydrochloride oral solution will be prepared to match the appearance, smell and taste of the metformin as closely as possible. For children from 6-9 years of age, placebo will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if placebo is well-tolerated, the dose will be increased to 500 mg twice daily. For children from 10-17 years of age, placebo will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if placebo is well-tolerated, the dose will be increased to 500 mg twice daily. At the Week 4 visit, if placebo is well-tolerated, the dose will be increased to 850 mg twice daily.
Metformin: Metformin will be dispensed in a liquid suspension of 100 mg/mL. For children 6-9 years of age, metformin will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if metformin is well-tolerated, the dose will be increased to 500 mg twice daily. For children from 10-17 years of age, metformin will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if metformin is well-tolerated, the dose will be increased to 500 mg twice daily. At the Week 4 visit, if metformin is well-tolerated, the dose will be increased to 850 mg twice daily.
Overall Number of Participants Analyzed 32 28
Mean (95% Confidence Interval)
Unit of Measure: centimetres
1.45
(0.39 to 2.51)
-0.21
(-1.32 to 0.91)
6.Secondary Outcome
Title Changes in Additional Body Composition Parameters (Hip Circumference)
Hide Description [Not Specified]
Time Frame Baseline, 16 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Hydrochloride Oral Solution Metformin
Hide Arm/Group Description:
Placebo: The placebo hydrochloride oral solution will be prepared to match the appearance, smell and taste of the metformin as closely as possible. For children from 6-9 years of age, placebo will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if placebo is well-tolerated, the dose will be increased to 500 mg twice daily. For children from 10-17 years of age, placebo will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if placebo is well-tolerated, the dose will be increased to 500 mg twice daily. At the Week 4 visit, if placebo is well-tolerated, the dose will be increased to 850 mg twice daily.
Metformin: Metformin will be dispensed in a liquid suspension of 100 mg/mL. For children 6-9 years of age, metformin will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if metformin is well-tolerated, the dose will be increased to 500 mg twice daily. For children from 10-17 years of age, metformin will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if metformin is well-tolerated, the dose will be increased to 500 mg twice daily. At the Week 4 visit, if metformin is well-tolerated, the dose will be increased to 850 mg twice daily.
Overall Number of Participants Analyzed 32 28
Mean (95% Confidence Interval)
Unit of Measure: centimetres
1.06
(-0.06 to 2.17)
-0.63
(-1.81 to 0.54)
7.Secondary Outcome
Title Changes in Fasting Metabolic Parameters (Total Cholesterol)
Hide Description [Not Specified]
Time Frame Baseline, 16 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Hydrochloride Oral Solution Metformin
Hide Arm/Group Description:
Placebo: The placebo hydrochloride oral solution will be prepared to match the appearance, smell and taste of the metformin as closely as possible. For children from 6-9 years of age, placebo will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if placebo is well-tolerated, the dose will be increased to 500 mg twice daily. For children from 10-17 years of age, placebo will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if placebo is well-tolerated, the dose will be increased to 500 mg twice daily. At the Week 4 visit, if placebo is well-tolerated, the dose will be increased to 850 mg twice daily.
Metformin: Metformin will be dispensed in a liquid suspension of 100 mg/mL. For children 6-9 years of age, metformin will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if metformin is well-tolerated, the dose will be increased to 500 mg twice daily. For children from 10-17 years of age, metformin will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if metformin is well-tolerated, the dose will be increased to 500 mg twice daily. At the Week 4 visit, if metformin is well-tolerated, the dose will be increased to 850 mg twice daily.
Overall Number of Participants Analyzed 32 28
Mean (95% Confidence Interval)
Unit of Measure: 16-week change total cholesterol (mg/dL)
-3.29
(-10.33 to 3.75)
-1.05
(-8.76 to 6.67)
8.Secondary Outcome
Title Changes in Fasting Metabolic Parameters (LDL)
Hide Description [Not Specified]
Time Frame Baseline, 16 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Hydrochloride Oral Solution Metformin
Hide Arm/Group Description:
Placebo: The placebo hydrochloride oral solution will be prepared to match the appearance, smell and taste of the metformin as closely as possible. For children from 6-9 years of age, placebo will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if placebo is well-tolerated, the dose will be increased to 500 mg twice daily. For children from 10-17 years of age, placebo will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if placebo is well-tolerated, the dose will be increased to 500 mg twice daily. At the Week 4 visit, if placebo is well-tolerated, the dose will be increased to 850 mg twice daily.
Metformin: Metformin will be dispensed in a liquid suspension of 100 mg/mL. For children 6-9 years of age, metformin will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if metformin is well-tolerated, the dose will be increased to 500 mg twice daily. For children from 10-17 years of age, metformin will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if metformin is well-tolerated, the dose will be increased to 500 mg twice daily. At the Week 4 visit, if metformin is well-tolerated, the dose will be increased to 850 mg twice daily.
Overall Number of Participants Analyzed 32 28
Mean (95% Confidence Interval)
Unit of Measure: 16-week change in LDL (mg/dL)
-0.41
(-6.11 to 5.29)
-4.41
(-10.47 to 1.64)
9.Secondary Outcome
Title Changes in Fasting Metabolic Parameters (HDL)
Hide Description [Not Specified]
Time Frame Baseline, 16 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Hydrochloride Oral Solution Metformin
Hide Arm/Group Description:
Placebo: The placebo hydrochloride oral solution will be prepared to match the appearance, smell and taste of the metformin as closely as possible. For children from 6-9 years of age, placebo will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if placebo is well-tolerated, the dose will be increased to 500 mg twice daily. For children from 10-17 years of age, placebo will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if placebo is well-tolerated, the dose will be increased to 500 mg twice daily. At the Week 4 visit, if placebo is well-tolerated, the dose will be increased to 850 mg twice daily.
Metformin: Metformin will be dispensed in a liquid suspension of 100 mg/mL. For children 6-9 years of age, metformin will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if metformin is well-tolerated, the dose will be increased to 500 mg twice daily. For children from 10-17 years of age, metformin will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if metformin is well-tolerated, the dose will be increased to 500 mg twice daily. At the Week 4 visit, if metformin is well-tolerated, the dose will be increased to 850 mg twice daily.
Overall Number of Participants Analyzed 32 28
Mean (95% Confidence Interval)
Unit of Measure: 16-week change in HDL (mg/dL)
-0.98
(-5.26 to 3.29)
3.27
(-1.41 to 7.94)
10.Secondary Outcome
Title Changes in Fasting Metabolic Parameters (Triglycerides)
Hide Description [Not Specified]
Time Frame Baseline, 16 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Hydrochloride Oral Solution Metformin
Hide Arm/Group Description:
Placebo: The placebo hydrochloride oral solution will be prepared to match the appearance, smell and taste of the metformin as closely as possible. For children from 6-9 years of age, placebo will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if placebo is well-tolerated, the dose will be increased to 500 mg twice daily. For children from 10-17 years of age, placebo will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if placebo is well-tolerated, the dose will be increased to 500 mg twice daily. At the Week 4 visit, if placebo is well-tolerated, the dose will be increased to 850 mg twice daily.
Metformin: Metformin will be dispensed in a liquid suspension of 100 mg/mL. For children 6-9 years of age, metformin will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if metformin is well-tolerated, the dose will be increased to 500 mg twice daily. For children from 10-17 years of age, metformin will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if metformin is well-tolerated, the dose will be increased to 500 mg twice daily. At the Week 4 visit, if metformin is well-tolerated, the dose will be increased to 850 mg twice daily.
Overall Number of Participants Analyzed 32 28
Mean (95% Confidence Interval)
Unit of Measure: 16-week change in triglycerides (mg/dL)
6.18
(-19.62 to 31.98)
5.74
(-22.34 to 33.81)
11.Secondary Outcome
Title Changes in Fasting Metabolic Parameters (Glucose)
Hide Description [Not Specified]
Time Frame Baseline, 16 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Hydrochloride Oral Solution Metformin
Hide Arm/Group Description:
Placebo: The placebo hydrochloride oral solution will be prepared to match the appearance, smell and taste of the metformin as closely as possible. For children from 6-9 years of age, placebo will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if placebo is well-tolerated, the dose will be increased to 500 mg twice daily. For children from 10-17 years of age, placebo will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if placebo is well-tolerated, the dose will be increased to 500 mg twice daily. At the Week 4 visit, if placebo is well-tolerated, the dose will be increased to 850 mg twice daily.
Metformin: Metformin will be dispensed in a liquid suspension of 100 mg/mL. For children 6-9 years of age, metformin will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if metformin is well-tolerated, the dose will be increased to 500 mg twice daily. For children from 10-17 years of age, metformin will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if metformin is well-tolerated, the dose will be increased to 500 mg twice daily. At the Week 4 visit, if metformin is well-tolerated, the dose will be increased to 850 mg twice daily.
Overall Number of Participants Analyzed 32 28
Mean (95% Confidence Interval)
Unit of Measure: 16-week change in gluclose (mg/dL)
-2.41
(-5.76 to 0.94)
-3.06
(-6.68 to 0.56)
12.Secondary Outcome
Title Changes in Fasting Metabolic Parameters (Insulin)
Hide Description [Not Specified]
Time Frame Baseline, 16 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Hydrochloride Oral Solution Metformin
Hide Arm/Group Description:
Placebo: The placebo hydrochloride oral solution will be prepared to match the appearance, smell and taste of the metformin as closely as possible. For children from 6-9 years of age, placebo will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if placebo is well-tolerated, the dose will be increased to 500 mg twice daily. For children from 10-17 years of age, placebo will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if placebo is well-tolerated, the dose will be increased to 500 mg twice daily. At the Week 4 visit, if placebo is well-tolerated, the dose will be increased to 850 mg twice daily.
Metformin: Metformin will be dispensed in a liquid suspension of 100 mg/mL. For children 6-9 years of age, metformin will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if metformin is well-tolerated, the dose will be increased to 500 mg twice daily. For children from 10-17 years of age, metformin will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if metformin is well-tolerated, the dose will be increased to 500 mg twice daily. At the Week 4 visit, if metformin is well-tolerated, the dose will be increased to 850 mg twice daily.
Overall Number of Participants Analyzed 32 28
Mean (95% Confidence Interval)
Unit of Measure: 16-week change insulin fasting (µIU/mL)
2.95
(-8.44 to 14.35)
1.97
(-10.44 to 14.38)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Hydrochloride Oral Solution Metformin
Hide Arm/Group Description Placebo: The placebo hydrochloride oral solution will be prepared to match the appearance, smell and taste of the metformin as closely as possible. For children from 6-9 years of age, placebo will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if placebo is well-tolerated, the dose will be increased to 500 mg twice daily. For children from 10-17 years of age, placebo will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if placebo is well-tolerated, the dose will be increased to 500 mg twice daily. At the Week 4 visit, if placebo is well-tolerated, the dose will be increased to 850 mg twice daily. Metformin: Metformin will be dispensed in a liquid suspension of 100 mg/mL. For children 6-9 years of age, metformin will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if metformin is well-tolerated, the dose will be increased to 500 mg twice daily. For children from 10-17 years of age, metformin will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if metformin is well-tolerated, the dose will be increased to 500 mg twice daily. At the Week 4 visit, if metformin is well-tolerated, the dose will be increased to 850 mg twice daily.
All-Cause Mortality
Placebo Hydrochloride Oral Solution Metformin
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Hydrochloride Oral Solution Metformin
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/32 (3.13%)      0/28 (0.00%)    
Psychiatric disorders     
Aggression * [1]  1/32 (3.13%)  1 0/28 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
[1]
history of hospital admission for aggression
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Hydrochloride Oral Solution Metformin
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   32/32 (100.00%)      28/28 (100.00%)    
Ear and labyrinth disorders     
Overall *  3/32 (9.38%)  4 0/28 (0.00%)  0
Gastrointestinal disorders     
Abdominal Discomfort *  3/32 (9.38%)  4 2/28 (7.14%)  3
Abdominal Pain *  3/32 (9.38%)  3 3/28 (10.71%)  3
Abdominal Pain, upper *  4/32 (12.50%)  4 3/28 (10.71%)  3
Abnormal Feces *  0/32 (0.00%)  0 3/28 (10.71%)  3
Chapped lips *  2/32 (6.25%)  2 1/28 (3.57%)  1
Constipation *  3/32 (9.38%)  4 2/28 (7.14%)  2
Diarrhea *  13/32 (40.63%)  19 17/28 (60.71%)  26
Flatulence *  3/32 (9.38%)  4 3/28 (10.71%)  3
Nausea *  3/32 (9.38%)  3 2/28 (7.14%)  3
Vomiting *  4/32 (12.50%)  8 8/28 (28.57%)  9
Overall *  19/32 (59.38%)  55 24/28 (85.71%)  64
General disorders     
Fatigue *  6/32 (18.75%)  6 6/28 (21.43%)  8
Irritability *  7/32 (21.88%)  7 7/28 (25.00%)  9
Product taste abnormal *  0/32 (0.00%)  0 3/28 (10.71%)  3
Pyrexia *  1/32 (3.13%)  2 3/28 (10.71%)  4
Overall *  14/32 (43.75%)  18 13/28 (46.43%)  27
Infections and infestations     
Ear Infection *  1/32 (3.13%)  1 2/28 (7.14%)  4
Gastroenteritis *  1/32 (3.13%)  1 3/28 (10.71%)  4
Otitis media *  1/32 (3.13%)  1 2/28 (7.14%)  2
Sinusitis *  2/32 (6.25%)  2 1/28 (3.57%)  1
Upper respiratory tract infection *  11/32 (34.38%)  11 6/28 (21.43%)  6
Overall *  19/32 (59.38%)  25 14/28 (50.00%)  24
Injury, poisoning and procedural complications     
Overall *  5/32 (15.63%)  5 4/28 (14.29%)  4
Investigations     
Blood insulin level increased *  2/32 (6.25%)  2 2/28 (7.14%)  2
Blood triglyceride level increased *  2/32 (6.25%)  2 1/28 (3.57%)  1
Overall *  5/32 (15.63%)  7 4/28 (14.29%)  4
Metabolism and nutrition disorders     
Decreased Appetite *  4/32 (12.50%)  4 8/28 (28.57%)  8
Increased Appetite *  4/32 (12.50%)  4 0/28 (0.00%)  0
Overall *  8/32 (25.00%)  8 8/28 (28.57%)  8
Musculoskeletal and connective tissue disorders     
Back pain *  2/32 (6.25%)  2 0/28 (0.00%)  0
Pain in Extremity *  1/32 (3.13%)  1 2/28 (7.14%)  2
Overall *  7/32 (21.88%)  9 4/28 (14.29%)  5
Nervous system disorders     
Dizziness *  1/32 (3.13%)  1 2/28 (7.14%)  2
Headache *  6/32 (18.75%)  9 5/28 (17.86%)  8
Somnolence *  3/32 (9.38%)  3 2/28 (7.14%)  2
Overall *  10/32 (31.25%)  16 12/28 (42.86%)  20
Psychiatric disorders     
Affect Lability *  4/32 (12.50%)  4 0/28 (0.00%)  0
Aggression *  2/32 (6.25%)  3 5/28 (17.86%)  6
Anger *  1/32 (3.13%)  1 4/28 (14.29%)  4
Anxiety *  3/32 (9.38%)  3 1/28 (3.57%)  1
Depressed Mood *  2/32 (6.25%)  2 0/28 (0.00%)  0
Initial Insomnia *  2/32 (6.25%)  3 3/28 (10.71%)  3
Middle Insomnia *  1/32 (3.13%)  1 2/28 (7.14%)  2
Overall *  13/32 (40.63%)  27 14/28 (50.00%)  27
Reproductive system and breast disorders     
Overall *  2/32 (6.25%)  2 1/28 (3.57%)  1
Respiratory, thoracic and mediastinal disorders     
Cough *  3/32 (9.38%)  3 2/28 (7.14%)  2
Nasal Congestion *  2/32 (6.25%)  2 3/28 (10.71%)  4
Rhinorrhea *  4/32 (12.50%)  4 2/28 (7.14%)  3
Sneezing *  3/32 (9.38%)  4 2/28 (7.14%)  2
Overall *  12/32 (37.50%)  19 8/28 (28.57%)  16
Skin and subcutaneous tissue disorders     
Rash *  2/32 (6.25%)  2 4/28 (14.29%)  4
Overall *  8/32 (25.00%)  8 6/28 (21.43%)  7
*
Indicates events were collected by non-systematic assessment
Treatment length doesn't capture metabolic benefits. Unable to evaluate maintenance of initial improvements. Limited information on length of overall exposure to antipsychotic medications. No evaluation on benefit of lifestyle.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. Evdokia Anagnostou
Organization: Holland Bloorview Kids Rehabilition Hospital
Phone: 416-753-6005
Responsible Party: Evdokia Anagnostou, Anagnostou, Evdokia, M.D.
ClinicalTrials.gov Identifier: NCT01825798     History of Changes
Other Study ID Numbers: MET-10-2012
First Submitted: February 7, 2013
First Posted: April 8, 2013
Results First Submitted: March 17, 2017
Results First Posted: February 22, 2018
Last Update Posted: February 22, 2018