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Metabolic Effects of Antipsychotics in Children (MEAC)

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ClinicalTrials.gov Identifier: NCT00205699
Recruitment Status : Completed
First Posted : September 20, 2005
Results First Posted : June 15, 2018
Last Update Posted : June 15, 2018
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Washington University School of Medicine

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Conditions Aggression
Attention Deficit-Hyperactivity
Oppositional Defiant Disorder
Pervasive Development Disorders
Bipolar Disorder
Interventions Drug: risperidone
Drug: olanzapine
Drug: aripiprazole
Enrollment 144
Recruitment Details  
Pre-assignment Details Post-enrollment screening for inclusion and exclusion criteria, e.g. for exclusionary conditions like diabetes mellitus.
Arm/Group Title Risperidone Olanzapine Aripiprazole
Hide Arm/Group Description 12 weeks of randomized treatment with flexibly dosed risperidone 12 weeks of randomized treatment with flexibly dosed olanzapine 12 weeks of randomized treatment with flexibly dosed aripiprazole
Period Title: Overall Study
Started 49 46 49
Completed 46 40 43
Not Completed 3 6 6
Reason Not Completed
Lost to Follow-up             1             3             5
Adverse Event             1             0             0
Withdrawal by Subject             1             2             1
Lack of Efficacy             0             1             0
Arm/Group Title Risperidone Olanzapine Aripiprazole Total
Hide Arm/Group Description 12 weeks randomized, flexibly-dosed treatment with risperidone 12 weeks randomized, flexibly-dosed treatment with olanzapine 12 weeks randomized, flexibly-dosed treatment with aripiprazole Total of all reporting groups
Overall Number of Baseline Participants 49 46 49 144
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 49 participants 46 participants 49 participants 144 participants
11.32  (2.95) 11.10  (2.52) 11.60  (2.92) 11.35  (2.79)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 49 participants 46 participants 49 participants 144 participants
Female
13
  26.5%
18
  39.1%
15
  30.6%
46
  31.9%
Male
36
  73.5%
28
  60.9%
34
  69.4%
98
  68.1%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 49 participants 46 participants 49 participants 144 participants
Hispanic or Latino
2
   4.1%
1
   2.2%
1
   2.0%
4
   2.8%
Not Hispanic or Latino
47
  95.9%
45
  97.8%
48
  98.0%
140
  97.2%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
White Number Analyzed 49 participants 46 participants 49 participants 144 participants
24 22 19 65
Non-White Number Analyzed 49 participants 46 participants 49 participants 144 participants
25 24 30 79
Primary Diagnosis  
Measure Type: Number
Unit of measure:  Participants
Attention Deficit Hyperactivity Disorder Number Analyzed 49 participants 46 participants 49 participants 144 participants
28 23 29 80
Disruptive Behavior Disorder Number Analyzed 49 participants 46 participants 49 participants 144 participants
8 11 13 32
Mood Disorder Number Analyzed 49 participants 46 participants 49 participants 144 participants
7 5 4 16
Autism Spectrum Disorder Number Analyzed 49 participants 46 participants 49 participants 144 participants
3 4 3 10
Psychosis Number Analyzed 49 participants 46 participants 49 participants 144 participants
2 2 0 4
Obsessive Compulsive Disorder Number Analyzed 49 participants 46 participants 49 participants 144 participants
0 1 0 1
Tourette Disorder Number Analyzed 49 participants 46 participants 49 participants 144 participants
1 0 0 1
Clinical Global Improvement (CGI)-Severity of Illness  
Measure Type: Number
Unit of measure:  Participants
Moderately ill Number Analyzed 49 participants 46 participants 49 participants 144 participants
18 19 23 60
Markedly ill Number Analyzed 49 participants 46 participants 49 participants 144 participants
31 26 23 80
Severely ill Number Analyzed 49 participants 46 participants 49 participants 144 participants
0 1 3 4
Aberrant Behavioral Checklist Subscales   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Total Number Analyzed 49 participants 46 participants 49 participants 144 participants
88.03  (23.96) 81.89  (21.55) 83.53  (25.70) 84.54  (23.82)
Irritability/Aggression Number Analyzed 49 participants 46 participants 49 participants 144 participants
28.49  (5.53) 28.17  (5.73) 28.14  (6.27) 28.27  (5.81)
Lethargy Number Analyzed 49 participants 46 participants 49 participants 144 participants
16.57  (10.01) 12.67  (8.15) 14.61  (8.83) 14.66  (9.12)
Stereotypy Number Analyzed 49 participants 46 participants 49 participants 144 participants
5.54  (4.95) 5.15  (4.42) 4.29  (4.61) 4.99  (4.67)
Hyperactivity Number Analyzed 49 participants 46 participants 49 participants 144 participants
32.83  (9.68) 32.11  (10.45) 32.80  (10.88) 32.59  (10.28)
Inappropriate Speech Number Analyzed 49 participants 46 participants 49 participants 144 participants
4.60  (3.02) 3.78  (2.71) 3.69  (2.76) 4.03  (2.85)
[1]
Measure Description: This instrument is a five-factor scale comprising 58 items in 5 sub scales. Items are scored on a scale of 0 (not a problem) to 3 (severe problem). Each sub scale score is the sum of items in the scale. The overall score is the sum of all items. Sub scales are Irritability (15 items, 0-45, clinical significance >18); Lethargy (16 items, min 0, max 48, clinical significance >9); Stereotypic Behavior; (7 items, 0 - 21, clinical significance >3) Hyperactivity, Noncompliance (16 items, 0-48, clinical significance >24); and Inappropriate Speech (4 items, 0-12, clinical significance >3).
Clinical Global Assessment of Functioning   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 49 participants 46 participants 49 participants 144 participants
51.71  (4.44) 50.67  (5.44) 50.88  (6.00) 51.10  (5.31)
[1]
Measure Description: This instrument is a global measure of severity based on psychiatric symptomatology and impairment of adaptation in family, social, school, and work areas. On this scale 0 is worst, 100 is best, and ≤ 60 is definite clinical impairment.
Number of Suspensions   [1] 
Mean (Standard Deviation)
Unit of measure:  Number of discrete school suspensions
Number Analyzed 43 participants 38 participants 46 participants 127 participants
2.60  (4.11) 2.71  (3.98) 2.85  (4.18) 2.72  (4.07)
[1]
Measure Analysis Population Description: Measure Analysis Population Description: The n's reported here represent complete data only.
On stimulant  
Measure Type: Number
Unit of measure:  Participants
Yes Number Analyzed 49 participants 46 participants 49 participants 144 participants
29 21 22 72
No Number Analyzed 49 participants 46 participants 49 participants 144 participants
20 25 27 72
On Selective Serotonin Reuptake Inhibitors (SSRI)  
Measure Type: Number
Unit of measure:  Participants
Yes Number Analyzed 49 participants 46 participants 49 participants 144 participants
8 5 4 17
No Number Analyzed 49 participants 46 participants 49 participants 144 participants
41 41 45 127
DEXA-measured body composition (%)  
Mean (Standard Deviation)
Unit of measure:  Percentage of body composition
DEXA Total % Fat Number Analyzed 49 participants 46 participants 49 participants 144 participants
26.25  (10.64) 24.48  (10.19) 26.23  (10.83) 25.68  (10.52)
DEXA Total % Lean Number Analyzed 49 participants 46 participants 49 participants 144 participants
70.30  (10.35) 71.96  (9.96) 70.32  (10.53) 70.84  (10.25)
DEXA-measured body composition (kg)  
Mean (Standard Deviation)
Unit of measure:  Kilograms
DEXA Total Fat kg Number Analyzed 49 participants 46 participants 49 participants 144 participants
12.50  (9.53) 10.46  (6.68) 13.24  (10.40) 12.10  (9.07)
DEXA Total Lean kg Number Analyzed 49 participants 46 participants 49 participants 144 participants
30.38  (11.01) 29.30  (9.83) 31.98  (14.69) 30.58  (12.04)
Baseline Insulin Stimulated % Change in Isotopomer Measurement during Week 0 Clamp   [1] 
Mean (Standard Deviation)
Unit of measure:  % change during baseline clamp
% Change in Glucose Rate of Disappearance Number Analyzed 42 participants 34 participants 41 participants 117 participants
166.26  (78.79) 168.75  (82.09) 156.49  (81.14) 163.56  (80.06)
% Change in Glucose Rate of Appearance Number Analyzed 42 participants 34 participants 41 participants 117 participants
83.19  (10.94) 82.53  (9.90) 82.70  (12.15) 82.83  (11.01)
% Change in Glycerol Rate of Appearance Number Analyzed 42 participants 34 participants 41 participants 117 participants
55.59  (13.42) 55.94  (15.08) 50.46  (15.04) 53.89  (14.59)
Whole Body Sensitivity Number Analyzed 47 participants 44 participants 48 participants 139 participants
12.96  (5.33) 12.53  (4.47) 12.87  (6.36) 12.80  (5.44)
[1]
Measure Analysis Population Description: Measure Analysis Population Description: Measure Analysis Population Description: The n's reported here represent complete data only.
MRI-measured abdominal fat   [1] 
Mean (Standard Deviation)
Unit of measure:  Cm squared
MRI Subcutaneous Fat Number Analyzed 34 participants 29 participants 33 participants 96 participants
121.38  (123.05) 86.17  (65.10) 111.16  (94.16) 107.23  (98.53)
MRI Visceral Fat Number Analyzed 34 participants 30 participants 33 participants 97 participants
25.79  (18.45) 19.37  (19.74) 26.70  (24.14) 24.11  (20.96)
MRI Total Fat Number Analyzed 34 participants 29 participants 33 participants 96 participants
147.17  (137.36) 106.09  (82.28) 137.85  (116.24) 131.56  (115.76)
[1]
Measure Analysis Population Description: The n's reported here represent complete data only.
Body Weight  
Mean (Standard Deviation)
Unit of measure:  Kilograms
Number Analyzed 49 participants 46 participants 49 participants 144 participants
45.49  (19.08) 42.23  (13.81) 47.94  (23.57) 45.28  (19.34)
Waist Circumference  
Mean (Standard Deviation)
Unit of measure:  Centimeters
Number Analyzed 49 participants 46 participants 49 participants 144 participants
68.72  (13.47) 65.87  (11.03) 69.54  (15.50) 68.09  (13.50)
Body Mass Index Percentile  
Mean (Standard Deviation)
Unit of measure:  Percentile
Number Analyzed 49 participants 46 participants 49 participants 144 participants
62.13  (29.70) 58.38  (31.33) 63.05  (30.12) 61.25  (30.22)
Body Mass index z-score  
Mean (Standard Deviation)
Unit of measure:  Z-score
Number Analyzed 49 participants 46 participants 49 participants 144 participants
0.49  (1.12) 0.30  (1.11) 0.55  (1.13) 0.45  (1.12)
Baseline fasting laboratory values (mg/dL)  
Mean (Standard Deviation)
Unit of measure:  mg/dL
Fasting Glucose Number Analyzed 49 participants 46 participants 49 participants 144 participants
89.14  (8.81) 87.48  (6.55) 88.98  (6.16) 88.56  (7.27)
Total Cholesterol Number Analyzed 49 participants 46 participants 49 participants 144 participants
144.74  (28.88) 137.09  (25.31) 135.45  (28.34) 139.14  (27.71)
Triglycerides Number Analyzed 49 participants 46 participants 49 participants 144 participants
60.40  (33.00) 60.98  (31.89) 52.16  (23.13) 57.78  (29.69)
LDL Cholesterol Number Analyzed 49 participants 46 participants 49 participants 144 participants
79.53  (25.41) 72.00  (24.56) 72.82  (26.00) 74.84  (25.40)
Total Bilirubin Number Analyzed 49 participants 46 participants 49 participants 144 participants
0.37  (0.25) 0.40  (0.18) 0.33  (0.18) 0.37  (0.21)
Baseline Fasting Laboratory Values (IU/L)  
Mean (Standard Deviation)
Unit of measure:  IU/L
Alanine aminotransferase (ALT) Number Analyzed 49 participants 46 participants 49 participants 144 participants
18.10  (7.74) 13.83  (4.20) 15.53  (4.49) 15.86  (5.96)
Aspartate aminostransferase (AST) Number Analyzed 49 participants 46 participants 49 participants 144 participants
25.65  (7.10) 23.26  (6.12) 23.94  (6.78) 24.31  (6.72)
Alkaline Phosphatase Number Analyzed 49 participants 46 participants 49 participants 144 participants
209.33  (88.42) 222.54  (75.69) 206.41  (85.35) 212.56  (83.19)
Baseline fasting laboratory values (g/dL)  
Mean (Standard Deviation)
Unit of measure:  g/dL
Albumin Number Analyzed 49 participants 46 participants 49 participants 144 participants
4.02  (0.25) 4.06  (0.27) 4.05  (0.25) 4.05  (0.25)
Total Protein Number Analyzed 49 participants 46 participants 49 participants 144 participants
6.95  (0.46) 6.90  (0.39) 6.95  (0.34) 6.94  (0.40)
High Sensitivity c-Reactive Protein (HS-CRP)   [1] 
Mean (Standard Deviation)
Unit of measure:  mg/L
Number Analyzed 48 participants 46 participants 48 participants 142 participants
1.61  (3.04) 1.37  (3.04) 1.12  (1.53) 1.37  (2.62)
[1]
Measure Analysis Population Description: The n's reported here represent complete data only.
Fasting Insulin   [1] 
Mean (Standard Deviation)
Unit of measure:  uU/mL
Number Analyzed 45 participants 43 participants 45 participants 133 participants
7.64  (5.85) 6.24  (3.74) 9.00  (8.68) 7.65  (6.50)
[1]
Measure Analysis Population Description: The n's reported here represent complete data only.
Hemoglobin A1c  
Mean (Standard Deviation)
Unit of measure:  %
Number Analyzed 49 participants 46 participants 49 participants 144 participants
5.46  (0.26) 5.54  (0.34) 5.54  (0.28) 5.52  (0.29)
1.Primary Outcome
Title Change in DEXA % Body Fat
Hide Description 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.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Intent to Treat (ITT) sample with week 0 and week 12 data.
Arm/Group Title Risperidone Olanzapine Aripiprazole
Hide Arm/Group Description:
12 weeks randomized, flexibly-dosed treatment with risperidone
12 weeks randomized, flexibly-dosed treatment with olanzapine
12 weeks randomized, flexibly-dosed treatment with aripiprazole
Overall Number of Participants Analyzed 46 40 42
Mean (Standard Deviation)
Unit of Measure: percent body fat
1.81  (3.11) 4.12  (3.10) 1.66  (2.65)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Risperidone, Olanzapine, Aripiprazole
Comments Primary analysis for change in DEXA % fat used a likelihood-based mixed-effects model using time (0, 6 and 12 weeks) and medication group as independent variables, with Toeplitz covariance structure specified, based on Bayesian information criteria (BIC). The null hypotheses were that there was no difference in the outcome over time (main effect of time) and that there were no differences between groups in the change over time (time by treatment condition).
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments The p value refers to the time by treatment condition interaction. The a priori threshold for statistical significance in this planned primary test was p<0.05.
Method Mixed Models Analysis
Comments [Not Specified]
2.Primary Outcome
Title Change in Insulin-stimulated Glucose Rate of Disappearance (Glucose Rd)
Hide Description 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.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Children ages 6-18 with a Diagnostic and Statistical Manual Text Revision (DSM-IV-TR) diagnosis and clinically significant aggression or irritability
Arm/Group Title Risperidone Olanzapine Aripiprazole
Hide Arm/Group Description:
12 weeks randomized, flexibly-dosed treatment with risperidone
12 weeks randomized, flexibly-dosed treatment with olanzapine
12 weeks randomized, flexibly-dosed treatment with aripiprazole
Overall Number of Participants Analyzed 39 33 40
Mean (Standard Deviation)
Unit of Measure: percentage of % change
2.30  (83.91) -29.34  (85.56) -30.26  (65.46)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Risperidone, Olanzapine, Aripiprazole
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.07
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
3.Secondary Outcome
Title Change in Insulin-stimulated Glycerol Rate of Appearance (Glycerol Ra)
Hide Description 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.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Intent to Treat (ITT) sample with week 0 and week 12 data.
Arm/Group Title Risperidone Olanzapine Aripiprazole
Hide Arm/Group Description:
12 weeks of randomized treatment with flexibly dosed risperidone
12 weeks of randomized treatment with flexibly dosed olanzapine
12 weeks of randomized treatment with flexibly dosed aripiprazole
Overall Number of Participants Analyzed 38 31 39
Mean (Standard Deviation)
Unit of Measure: percentage of % change
-3.65  (17.23) -8.29  (22.39) 1.70  (16.79)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Risperidone, Olanzapine, Aripiprazole
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.27
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
4.Secondary Outcome
Title Change in Insulin-stimulated Glucose Rate of Appearance (Glucose Ra)
Hide Description 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.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Intent to Treat (ITT) sample with week 0 and week 12 data.
Arm/Group Title Risperidone Olanzapine Aripiprazole
Hide Arm/Group Description:
12 weeks of randomized treatment with flexibly dosed risperidone
12 weeks of randomized treatment with flexibly dosed olanzapine
12 weeks of randomized treatment with flexibly dosed aripiprazole
Overall Number of Participants Analyzed 39 33 40
Mean (Standard Deviation)
Unit of Measure: percentage of % change
-2.50  (7.61) -6.57  (13.16) -3.27  (9.27)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Risperidone, Olanzapine, Aripiprazole
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.17
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
5.Secondary Outcome
Title Change in MRI-measured Visceral Abdominal Fat
Hide Description 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.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Intent to Treat (ITT) sample with week 0 and week 12 data.
Arm/Group Title Risperidone Olanzapine Aripiprazole
Hide Arm/Group Description:
12 weeks of randomized treatment with flexibly dosed risperidone
12 weeks of randomized treatment with flexibly dosed olanzapine
12 weeks of randomized treatment with flexibly dosed aripiprazole
Overall Number of Participants Analyzed 30 26 30
Mean (Standard Deviation)
Unit of Measure: Change in cm-squared
6.85  (10.99) 10.73  (14.50) 12.04  (15.11)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Risperidone, Olanzapine, Aripiprazole
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.29
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
6.Secondary Outcome
Title Change in MRI-measured Subcutaneous Abdominal Fat
Hide Description 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.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Intent to Treat (ITT) sample with week 0 and week 12 data.
Arm/Group Title Risperidone Olanzapine Aripiprazole
Hide Arm/Group Description:
12 weeks of randomized treatment with flexibly dosed risperidone
12 weeks of randomized treatment with flexibly dosed olanzapine
12 weeks of randomized treatment with flexibly dosed aripiprazole
Overall Number of Participants Analyzed 30 26 30
Mean (Standard Deviation)
Unit of Measure: Change in cm-squared
18.21  (22.27) 34.27  (27.22) 15.84  (19.02)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Risperidone, Olanzapine, Aripiprazole
Comments Repeated measures ANCOVA was used to test for the main effect of time on the outcome, and to test for a time by treatment condition interaction that would indicate differences between groups in change over time in the primary outcome. The null hypotheses were that there was no difference in the outcome over time (main effect of time) and that there were no differences between groups in the change over time (time by treatment condition).
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.003
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Risperidone, Olanzapine
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.003
Comments Bonferroni correction for multiple comparisons was applied (p<0.05/4 = 0.0125).
Method Contrast
Comments Contrasts based on the ANCOVA-derived time by treatment condition interaction.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Olanzapine, Aripiprazole
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments Bonferroni correction for multiple comparisons was applied (p<0.05/4 = 0.0125).
Method ANCOVA
Comments Contrasts based on the ANCOVA-derived time by treatment condition interaction.
Time Frame Adverse events were collected throughout the entire course of the study, April 2006 to July 2011 or 6 years and 3 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Aripiprazole Olanzapine Risperidone
Hide Arm/Group Description Participants in this group were randomized to treatment with aripiprazole. Participants in this group were randomized to treatment with olanzapine. Participants in this group were randomized to treatment with risperidone.
All-Cause Mortality
Aripiprazole Olanzapine Risperidone
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/49 (0.00%)      0/46 (0.00%)      0/49 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Aripiprazole Olanzapine Risperidone
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/49 (0.00%)      0/46 (0.00%)      1/49 (2.04%)    
Nervous system disorders       
Seizure * [1]  0/49 (0.00%)  0 0/46 (0.00%)  0 1/49 (2.04%)  1
*
Indicates events were collected by non-systematic assessment
[1]
About 2 months after starting Risperidone, participant had a complex partial seizure, later determined by a neurologist to be unrelated to study medication. Participant was restarted on the Risperidone.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Aripiprazole Olanzapine Risperidone
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   38/49 (77.55%)      38/46 (82.61%)      39/49 (79.59%)    
Psychiatric disorders       
Accidental Injury   3/49 (6.12%)  3/46 (6.52%)  5/49 (10.20%) 
Agitation   15/49 (30.61%)  21/46 (45.65%)  16/49 (32.65%) 
Anxiety   9/49 (18.37%)  10/46 (21.74%)  13/49 (26.53%) 
Constipation   1/49 (2.04%)  2/46 (4.35%)  7/49 (14.29%) 
Depression   1/49 (2.04%)  5/46 (10.87%)  4/49 (8.16%) 
Difficulty Concentrating   10/49 (20.41%)  12/46 (26.09%)  16/49 (32.65%) 
Drowsiness/Somnolence   11/49 (22.45%)  10/46 (21.74%)  8/49 (16.33%) 
Headache   4/49 (8.16%)  4/46 (8.70%)  5/49 (10.20%) 
Increased Appetite   18/49 (36.73%)  31/46 (67.39%)  15/49 (30.61%) 
Involuntary Movements   0/49 (0.00%)  1/46 (2.17%)  4/49 (8.16%) 
Restlessness   12/49 (24.49%)  12/46 (26.09%)  14/49 (28.57%) 
Runny Nose   6/49 (12.24%)  1/46 (2.17%)  1/49 (2.04%) 
Sleepiness   5/49 (10.20%)  9/46 (19.57%)  4/49 (8.16%) 
Thirst   1/49 (2.04%)  3/46 (6.52%)  1/49 (2.04%) 
Tiredness/Fatigue   6/49 (12.24%)  6/46 (13.04%)  2/49 (4.08%) 
Trouble Sleeping   4/49 (8.16%)  3/46 (6.52%)  8/49 (16.33%) 
Weight Gain   11/49 (22.45%)  23/46 (50.00%)  20/49 (40.82%) 
Indicates events were collected by systematic assessment
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
Layout table for Results Point of Contact information
Name/Title: John W. Newcomer
Organization: Florida Atlantic University
Phone: (561) 297-0252
EMail: jnewcomer@health.fau.edu
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Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00205699     History of Changes
Other Study ID Numbers: NIMH
R01MH072912 ( U.S. NIH Grant/Contract )
First Submitted: September 13, 2005
First Posted: September 20, 2005
Results First Submitted: June 21, 2017
Results First Posted: June 15, 2018
Last Update Posted: June 15, 2018