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Characterization and Sequential Pharmacotherapy of Severe Mood Dysregulation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01714310
Recruitment Status : Completed
First Posted : October 25, 2012
Results First Posted : February 26, 2018
Last Update Posted : February 26, 2018
Sponsor:
Collaborators:
National Institute of Mental Health (NIMH)
Shire
Information provided by (Responsible Party):
James McGough, University of California, Los Angeles

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Severe Mood Dysregulation
Interventions Drug: lisdexamfetamine
Drug: Placebo
Drug: fluoxetine
Enrollment 34
Recruitment Details  
Pre-assignment Details At completion of open lisdexamfetamine, participants who achieved Clinical Global Impression Severity (CGI-S) SMD score < 4 were deemed sufficiently improved, and not randomized to adjunctive treatment. N=4 participants were sufficiently improved and completed study participation at study week 4, prior to randomization
Arm/Group Title Fluoxetine Placebo Open Lisdexamfetamine
Hide Arm/Group Description All participants initially enrolled in open lisdexamfetamine treatment, followed by randomization to adjunctive fluoxetine at study week 4 and continuing to study week 12. All participants initially enrolled in open lisdexamfetamine treatment, followed by randomization to adjunctive placebo at study week 4 and continuing through study week 12. All eligible participants initially titrated to optimal dose open lisdexamfetamine beginning at baseline (week 0) and continuing to the end of study week 4.
Period Title: Open Lisdexamfetamine Titration
Started 0 0 34
Completed 0 0 30
Not Completed 0 0 4
Reason Not Completed
Protocol Violation             0             0             1
Adverse Event             0             0             3
Period Title: Double Blind Adjunctive Treatment
Started 12 [1] 14 [2] 0 [3]
Completed 10 11 0
Not Completed 2 3 0
Reason Not Completed
Adverse Event             1             1             0
Protocol Violation             1             2             0
[1]
Adjunctive fluoxetine treatment was initiated at beginning of Period 2, at study week 4.
[2]
Adjunctive placebo was initiated at beginning of Period 2, at study week 4.
[3]
No one remained on lisdexamfetamine alone in Period 2.
Arm/Group Title Open Lisdexamfetamine Fluoxetine Placebo Total
Hide Arm/Group Description All eligible participants initially titrated to optimal dose open lisdexamfetamine from baseline through week 3. Randomized participants who competed open-label lisdexamfetamine titration from baseline through week 3, who continued to meet eligibility criteria, and then proceeded to adjunctive fluoxetine therapy from week 4 through week 12. Randomized participants who competed open-label lisdexamfetamine titration from baseline through week 3, who continued to meet eligibility criteria, and then proceeded to adjunctive placebo from week 4 through week 12. Total of all reporting groups
Overall Number of Baseline Participants 34 12 14 60
Hide Baseline Analysis Population Description
See Participant Flow descriptions.
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 34 participants 12 participants 14 participants 60 participants
10.24  (2.58) 9.97  (2.30) 10.22  (2.74) NA [2]   (NA)
[1]
Measure Description: Columns for baseline measures are not additive, as fluoxetine and placebo groups are a subset of the original 34 participants entered into phase 1.
[2]
Columns are not additive, as described above.
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 34 participants 12 participants 14 participants 60 participants
Female
13
  38.2%
5
  41.7%
5
  35.7%
23
  38.3%
Male
21
  61.8%
7
  58.3%
9
  64.3%
37
  61.7%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 34 participants 12 participants 14 participants 60 participants
Hispanic or Latino
6
  17.6%
5
  41.7%
0
   0.0%
11
  18.3%
Not Hispanic or Latino
28
  82.4%
7
  58.3%
14
 100.0%
49
  81.7%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 34 participants 12 participants 14 participants 60 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
1
   2.9%
0
   0.0%
0
   0.0%
1
   1.7%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
1
   2.9%
0
   0.0%
0
   0.0%
1
   1.7%
White
27
  79.4%
8
  66.7%
13
  92.9%
48
  80.0%
More than one race
5
  14.7%
4
  33.3%
1
   7.1%
10
  16.7%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Wechsler Abbreviated Scale of Intelligence   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 34 participants 12 participants 14 participants 60 participants
103.16  (14.30) 105.58  (15.56) 101.69  (14.34) NA [2]   (NA)
[1]
Measure Description: Standard IQ measure for youth, frequently used in clinical studies, based on an administered test, with mean population score = 100.
[2]
Columns not additive as described above.
Clinical Global Impression SMD Severity   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 34 participants 12 participants 14 participants 60 participants
4.82  (.52) 4.75  (.46) 4.83  (.72) NA [2]   (NA)
[1]
Measure Description: A dimensional NIH measures used to quantify severity of severe mood dysregulation. Minimum score = 1. Maximum score = 7. Higher scores mean greater impairment.
[2]
Columns not additive as described above.
Affective Reactivity Index Parent Report   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 34 participants 12 participants 14 participants 60 participants
8.91  (2.47) 10.00  (1.95) 8.57  (2.17) NA [2]   (NA)
[1]
Measure Description: A parent completed dimensional measure of irritability on a scale of 0 to 14, with 14 being most severe.
[2]
Columns not additive as described above.
1.Primary Outcome
Title Clinical Global Impression-Severity-Severe Mood Dysregulation
Hide Description A dimensional clinician rating of overall SMD related impairment, modified by the National Institute of Mental Health to assess specific domains pertinent to Severe Mood Dysregulation. Minimum score = 1. Maximum score = 7. Higher scores means greater impairment.
Time Frame Baseline through week 12.
Hide Outcome Measure Data
Hide Analysis Population Description
Compares groups lisdexamfetamine plus fluoxetine vs. lisdexamfetamine plus placebo over 12 week trial. Some participants discontinued as trial progressed.
Arm/Group Title Fluoxetine Placebo Open Lisdexamfetamine
Hide Arm/Group Description:
All participants initially enrolled in open lisdexamfetamine treatment, followed by randomization to adjunctive fluoxetine at week 4 continuing to week 12.
All participants initially enrolled in open lisdexamfetamine treatment, followed by randomization to adjunctive placebo at week 4 continuing through week 12.
All eligible participants initially titrated to optimal dose open lisdexamfetamine starting at baseline (week 0) and continuing through study week.
Overall Number of Participants Analyzed 12 14 34
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Baseline Number Analyzed 12 participants 14 participants 34 participants
4.91  (.53) 3.62  (.48) 4.30  (.32)
Week 4 Number Analyzed 12 participants 14 participants 30 participants
4.42  (.34) 4.57  (.31) 4.31  (.19)
Week 5 Number Analyzed 12 participants 14 participants 0 participants
4.15  (.36) 3.51  (.32)
Week 6 Number Analyzed 12 participants 14 participants 0 participants
3.67  (.34) 3.90  (.33)
Week 7 Number Analyzed 10 participants 14 participants 0 participants
3.61  (.37) 3.59  (.34)
Week 8 Number Analyzed 10 participants 13 participants 0 participants
3.42  (.39) 3.37  (.34)
Week 10 Number Analyzed 10 participants 11 participants 0 participants
3.45  (.42) 3.11  (.35)
Week 12 Number Analyzed 10 participants 11 participants 0 participants
3.51  (.38) 3.30  (.36)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fluoxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .58
Comments Group: F=.31, df=1/140
Method Mixed Models Analysis
Comments Partial linear regression using mixed model, assessing outcome variable over time (baseline to study week 12) and time2 (study weeks 4-12).
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Fluoxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .85
Comments Partial linear regression using mixed model, assessing outcome variable over time (baseline to study week 12) and time2 (study weeks 4-12).
Method Mixed Models Analysis
Comments Time: F=.03, df=1/140
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Fluoxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .26
Comments Partial linear regression using mixed model, assessing outcome variable over time (baseline to study week 12) and time2 (study weeks 4-12).
Method Mixed Models Analysis
Comments Time2: F=1.28, df=1/140
2.Secondary Outcome
Title ADHD-IV Rating Scale
Hide Description A dimensional rating of ADHD symptoms, with scores ranging from 0 - 54, and higher scores indicating greater symptom severity.
Time Frame Baseline through week 12.
Hide Outcome Measure Data
Hide Analysis Population Description
Participants discontinued as trial progressed.
Arm/Group Title Fluoxetine Placebo Open Lisdexamfetamine
Hide Arm/Group Description:
All participants initially enrolled in open lisdexamfetamine treatment, followed by randomization to adjunctive fluoxetine at end of study week 4 6 continuing through week 12.
All participants initially enrolled in open lisdexamfetamine treatment, followed by randomization to adjunctive placebo at end of study week 4 and continuing through week.
All eligible participants initially titrated to optimal dose open lisdexamfetamine at study visits 2-6.
Overall Number of Participants Analyzed 12 14 34
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Baseline Number Analyzed 12 participants 14 participants 34 participants
34.50  (1.97) 34.31  (1.87) 34.20  (1.15)
Week 4 Number Analyzed 12 participants 14 participants 30 participants
14.92  (1.97) 18.64  (1.82) 16.59  (1.21)
Week 12 Number Analyzed 10 participants 11 participants 0 participants
16.29  (2.10) 11.93  (1.99)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fluoxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .97
Comments Group: F=0.00, df=1/44
Method Mixed Models Analysis
Comments Partial linear regression using mixed model, assessing outcome variable over time (baseline through week 12) and time2 (weeks 4-12).
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Fluoxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.0002
Comments Partial linear regression using mixed model, assessing outcome variable over time (baseline to study week 12) and time2 (study weeks 4-12).
Method Mixed Models Analysis
Comments Time: F=136.22, df=1/44
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Fluoxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.0001
Comments Partial linear regression using mixed model, assessing outcome variable over time (baseline to study week 12) and time2 (study weeks 4-12).
Method Mixed Models Analysis
Comments Time2: F=64.90, df=1/44
3.Secondary Outcome
Title Conners Parent Global Index
Hide Description Parent completed dimensional measure of ADHD symptoms, with score range from 0 - 30 and higher scores indicating more severe symptoms.
Time Frame Baseline through week 3.
Hide Outcome Measure Data
Hide Analysis Population Description
Participants were assessed on this measure only during the Open Lisdexamfetamine phase. Some participant discontinued as trial progressed.
Arm/Group Title Fluoxetine Placebo Open Lisdexamfetamine
Hide Arm/Group Description:
All participants initially enrolled in open lisdexamfetamine treatment, followed by randomization to adjunctive fluoxetine at week 4 continuing tp week 12.
All participants initially enrolled in open lisdexamfetamine treatment, followed by randomization to adjunctive placebo at week 4 and continuing through week 12.
All eligible participants initially titrated to optimal dose open lisdexamfetamine beginning at baseline (week 0) and continuing through study week 4.
Overall Number of Participants Analyzed 0 0 34
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Baseline Number Analyzed 0 participants 0 participants 34 participants
15.91  (.82)
Week 1 Number Analyzed 0 participants 0 participants 33 participants
9.54  (.82)
Week 2 Number Analyzed 0 participants 0 participants 33 participants
10.60  (.85)
Week 3 Number Analyzed 0 participants 0 participants 31 participants
8.60  (.87)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Open Lisdexamfetamine
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Time: F=41.85, df=1/89, p<.0001.
Method Mixed Models Analysis
Comments Linear regression of outcome change over time within single group.
4.Secondary Outcome
Title Conners Global Index Emotional Lability Subscale - Parent Report
Hide Description A sub scale of the Conners Global Index, with scores ranging from 0 - 12, with higher scores indicating more impairment.
Time Frame Baseline to week 3.
Hide Outcome Measure Data
Hide Analysis Population Description
Participants were assessed on this measure only during the Open Lisdexamfetamine phase. Some participants discontinues as trial progressed.
Arm/Group Title Fluoxetine Placebo Open Lisdexamfetamine
Hide Arm/Group Description:
All participants initially enrolled in open lisdexamfetamine treatment, followed by randomization to adjunctive fluoxetine at week 4 continuing to week 12.
All participants initially enrolled in open lisdexamfetamine treatment, followed by randomization to adjunctive placebo at week 4 continuing through week 12.
All eligible participants initially titrated to optimal dose open lisdexamfetamine beginning at baseline (week 0) and continuing through week 4.
Overall Number of Participants Analyzed 0 0 34
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Baseline Number Analyzed 0 participants 0 participants 34 participants
8.81  (.52)
Week 1 Number Analyzed 0 participants 0 participants 33 participants
5.90  (.52)
Week 2 Number Analyzed 0 participants 0 participants 33 participants
6.33  (.53)
Week 3 Number Analyzed 0 participants 0 participants 31 participants
5.45  (.55)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Open Lisdexamfetamine
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Time: F=26.65, df=1/92, p <.0001.
Method Mixed Models Analysis
Comments Linear regression of outcome change over time within single group.
5.Secondary Outcome
Title Conners Global Index Restless-Impulsive Subscale Parent Report
Hide Description A dimensional parent report measure of restless-impulsive symptoms, with scores ranging from 0 to 21, and higher scores indicating greater impairment.
Time Frame Baseline through week 3.
Hide Outcome Measure Data
Hide Analysis Population Description
Participants were assessed on this measure only during the Open Lisdexamfetamine phase. Some participants discontinued as trial progressed.
Arm/Group Title Fluoxetine Placebo Open Lisdexamfetamine
Hide Arm/Group Description:
All participants initially enrolled in open lisdexamfetamine treatment, followed by randomization to adjunctive fluoxetine at week 4 continuing to week 12.
All participants initially enrolled in open lisdexamfetamine treatment, followed by randomization to adjunctive placebo at week 4 though week 12.
All eligible participants initially titrated to optimal dose open lisdexamfetamine at study visits 2-6.
Overall Number of Participants Analyzed 0 0 34
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Baseline Number Analyzed 0 participants 0 participants 34 participants
15.91  (.82)
Week 1 Number Analyzed 0 participants 0 participants 33 participants
9.55  (.82)
Week 2 Number Analyzed 0 participants 0 participants 33 participants
10.60  (.85)
Week 3 Number Analyzed 0 participants 0 participants 31 participants
8.60  (.87)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Open Lisdexamfetamine
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Time: F=40.35, df=1/89, p < .0001.
Method Mixed Models Analysis
Comments Linear regression of outcome change over time within single group.
6.Secondary Outcome
Title Conners Teacher Global Index
Hide Description Teacher completed dimensional measure of ADHD symptoms, with scores ranging from 0 - 30, and higher scores indicating more severe impairment.
Time Frame Baseline through week 3.
Hide Outcome Measure Data
Hide Analysis Population Description
Participants were assessed on this measure only during the Open Lisdexamfetamine phase. Some participants discontinued as trial progressed.
Arm/Group Title Fluoxetine Placebo Open Lisdexamfetamine
Hide Arm/Group Description:
All participants initially enrolled in open lisdexamfetamine treatment, followed by randomization to adjunctive fluoxetine at week 4 continuing to week 12.
All participants initially enrolled in open lisdexamfetamine treatment, followed by randomization to adjunctive placebo at week 4 continuing through week 12.
All eligible participants initially titrated to optimal dose open lisdexamfetamine beginning at baseline (week 0) and continuing through study week 4.
Overall Number of Participants Analyzed 0 0 34
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Baseline Number Analyzed 0 participants 0 participants 34 participants
18.13  (1.87)
Week 1 Number Analyzed 0 participants 0 participants 33 participants
13.21  (1.87)
Week 2 Number Analyzed 0 participants 0 participants 33 participants
10.18  (1.93)
Week 3 Number Analyzed 0 participants 0 participants 31 participants
8.31  (1.61)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Open Lisdexamfetamine
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Time: F=26.36, df=1/29, p <.0001.
Method Mixed Models Analysis
Comments Linear regression of outcome change over time within single group.
7.Secondary Outcome
Title Affective Reactivity Index - Parent Report
Hide Description A parent completed dimensional measure of emotional reactivity, with scores ranging from 0-12, and higher scores indicating greater severity.
Time Frame Baseline through week 12.
Hide Outcome Measure Data
Hide Analysis Population Description
Some participants discontinued as trial progressed.
Arm/Group Title Fluoxetine Placebo Open Lisdexamfetamine
Hide Arm/Group Description:
All participants initially enrolled in open lisdexamfetamine treatment, followed by randomization to adjunctive fluoxetine at week 4 continuing to week 12.
All participants initially enrolled in open lisdexamfetamine treatment, followed by randomization to adjunctive placebo at week 4 continuing through week 12.
All eligible participants initially titrated to optimal dose open lisdexamfetamine beginning at baseline (week 0) and continuing through study week 4.
Overall Number of Participants Analyzed 12 14 34
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Baseline Number Analyzed 12 participants 14 participants 34 participants
10.00  (.96) 8.57  (.88) 9.29  (.92)
Week 4 Number Analyzed 12 participants 14 participants 30 participants
7.58  (.96) 7.71  (.88) 6.87  (.59)
Week 5 Number Analyzed 12 participants 14 participants 0 participants
6.58  (.96) 6.21  (.88)
Week 6 Number Analyzed 12 participants 14 participants 0 participants
6.42  (.96) 5.32  (.90)
Week 7 Number Analyzed 10 participants 14 participants 0 participants
6.69  (1.00) 6.49  (1.00)
Week 8 Number Analyzed 10 participants 13 participants 0 participants
6.49  (1.00) 5.62  (.90)
Week 10 Number Analyzed 10 participants 11 participants 0 participants
6.74  (1.07) 4.89  (.97)
Week 12 Number Analyzed 10 participants 11 participants 0 participants
6.39  (1.00) 5.30  (.94)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fluoxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .44
Comments Group: F=.60, df=1/157
Method Mixed Models Analysis
Comments Partial linear regression using mixed model, assessing outcome variable over time (baseline to study week 12) and time2 (study weeks 4-12).
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Fluoxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.0001
Comments Partial linear regression using mixed model, assessing outcome variable over time (baseline to study week 12) and time2 (study weeks 4-12).
Method Mixed Models Analysis
Comments Time: F=22.39, df=1/157
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Fluoxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .04
Comments Partial linear regression using mixed model, assessing outcome variable over time (baseline to study week 12) and time2 (study weeks 4-12).
Method Mixed Models Analysis
Comments Time2: F=4.40, df=1/157
8.Secondary Outcome
Title Revised Modified Overt Aggression Scale - Total Score
Hide Description A parent rated retrospective dimensional assessment of oppositional and aggressive behaviors, with scores ranging from 0-40, and higher scores indicating greater severity.
Time Frame Baseline through week 12.
Hide Outcome Measure Data
Hide Analysis Population Description
Some participants discontinued as trial progressed.
Arm/Group Title Fluoxetine Placebo Open Lisdexamfetamine
Hide Arm/Group Description:
All participants initially enrolled in open lisdexamfetamine treatment, followed by randomization to adjunctive fluoxetine at week 4 continuing to week 12.
All participants initially enrolled in open lisdexamfetamine treatment, followed by randomization to adjunctive placebo at week 4 continuing through week 12.
All eligible participants initially titrated to optimal dose open lisdexamfetamine beginning at baseline (week 0) and continuing through study week 4.
Overall Number of Participants Analyzed 12 14 34
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Baseline Number Analyzed 12 participants 14 participants 34 participants
22.23  (4.44) 33.68  (4.08) 26.03  (2.61)
Week 4 Number Analyzed 12 participants 14 participants 30 participants
14.44  (4.30) 25.35  (3.98) 17.93  (2.67)
Week 5 Number Analyzed 12 participants 14 participants 0 participants
13.72  (4.31) 20.60  (4.19)
Week 6 Number Analyzed 12 participants 14 participants 0 participants
10.00  (4.20) 20.55  (3.98)
Week 7 Number Analyzed 10 participants 14 participants 0 participants
13.19  (4.45) 21.89  (4.32)
Week 8 Number Analyzed 10 participants 13 participants 0 participants
14.09  (4.45) 21.33  (4.08)
Week 10 Number Analyzed 10 participants 11 participants 0 participants
12.61  (4.60) 17.68  (4.47)
Week 12 Number Analyzed 10 participants 11 participants 0 participants
14.29  (4.45) 18.34  (4.32)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fluoxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .05
Comments Group: F=3.81, df=1/145
Method Mixed Models Analysis
Comments Partial linear regression using mixed model, assessing outcome variable over time (baseline to study week 12) and time2 (study weeks 4-12).
Other Statistical Analysis No significant group*time interactions. Group trend likely due to baseline differences.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Fluoxetine
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .0001
Comments Partial linear regression using mixed model, assessing outcome variable over time (baseline to study week 12) and time2 (study weeks 4-12).
Method Mixed Models Analysis
Comments Tie: F=15.28, df=1/145
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Fluoxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .02
Comments Partial linear regression using mixed model, assessing outcome variable over time (baseline to study week 12) and time2 (study weeks 4-12).
Method Mixed Models Analysis
Comments Time2: F=5.42, df=1/145
9.Secondary Outcome
Title Clinical Global Impression - Improvement
Hide Description Percentage improved by treatment group
Time Frame Percentage improved at week 4 for Open Lisdexamfetamine group and at week 12 for fluoxetine and placebo groups.
Hide Outcome Measure Data
Hide Analysis Population Description
Some participants discontinued as trial progressed.
Arm/Group Title Fluoxetine Placebo Open Lisdexamfetamine
Hide Arm/Group Description:
All participants initially enrolled in open lisdexamfetamine treatment, followed by randomization to adjunctive fluoxetine at study week 4 and continuing to study week 12.
All participants initially enrolled in open lisdexamfetamine treatment, followed by randomization to adjunctive placebo at study week 4 and continuing through study week 12.
All eligible participants initially titrated to optimal dose open lisdexamfetamine beginning at baseline (week 0) and continuing through study week 4.
Overall Number of Participants Analyzed 10 11 34
Measure Type: Count of Participants
Unit of Measure: Participants
7
  70.0%
7
  63.6%
8
  23.5%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fluoxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .76
Comments [Not Specified]
Method Chi-squared
Comments Chi Square = .10, df=1, p=.76
10.Secondary Outcome
Title Height
Hide Description A dimensional measure assessed in cms.
Time Frame Baseline through week 12.
Hide Outcome Measure Data
Hide Analysis Population Description
Participants discontinued as trial progressed.
Arm/Group Title Fluoxetine Placebo Open Lisdexamfetamine
Hide Arm/Group Description:
All participants initially enrolled in open lisdexamfetamine treatment, followed by randomization to adjunctive fluoxetine at week 4 continuing to week 12.
All participants initially enrolled in open lisdexamfetamine treatment, followed by randomization to adjunctive placebo at week 4 continuing through week 12.
All eligible participants initially titrated to optimal dose open lisdexamfetamine beginning at baseline (week 0) and continuing through study week 4.
Overall Number of Participants Analyzed 12 14 34
Least Squares Mean (Standard Error)
Unit of Measure: cm.
Baseline Number Analyzed 12 participants 14 participants 34 participants
140.25  (3.82) 144.63  (3.53) 142.37  (2.12)
Week 1 Number Analyzed 12 participants 14 participants 32 participants
140.05  (3.81) 144.76  (3.53) 142.35  (2.12)
Week 2 Number Analyzed 12 participants 14 participants 32 participants
139.95  (3.82) 144.81  (3.53) 142.43  (2.12)
Week 3 Number Analyzed 12 participants 14 participants 30 participants
140.26  (3.82) 144.88  (3.53) 142.59  (2.12)
Week 4 Number Analyzed 12 participants 14 participants 30 participants
140.56  (3.82) 144.54  (3.53) 142.59  (2.12)
Week 5 Number Analyzed 12 participants 14 participants 0 participants
140.11  (3.82) 144.82  (3.53)
Week 6 Number Analyzed 12 participants 14 participants 0 participants
140.21  (3.82) 145.44  (3.53)
Week 7 Number Analyzed 10 participants 14 participants 0 participants
140.55  (3.82) 145.14  (3.53)
Week 8 Number Analyzed 10 participants 13 participants 0 participants
140.81  (3.82) 144.98  (3.53)
Week 10 Number Analyzed 10 participants 11 participants 0 participants
140.83  (3.82) 145.30  (3.54)
Week 12 Number Analyzed 10 participants 11 participants 0 participants
140.98  (3.82) 145.60  (3.53)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fluoxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .38
Comments Group: F=.78, df=1/220
Method Mixed Models Analysis
Comments Partial linear regression using mixed model, assessing outcome variable over time (baseline through week 12) and time2 (weeks 4-12).
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Fluoxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .42
Comments Partial linear regression using mixed model, assessing outcome variable over time (baseline to study week 12) and time2 (study weeks 4-12).
Method Mixed Models Analysis
Comments Time: F=.66, df=1/220
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Fluoxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .13
Comments Partial linear regression using mixed model, assessing outcome variable over time (baseline to study week 12) and time2 (study weeks 4-12).
Method Mixed Models Analysis
Comments Time2: F=.66, df=1/220
11.Secondary Outcome
Title Weight
Hide Description Weight in kg.
Time Frame Baseline through week 12.
Hide Outcome Measure Data
Hide Analysis Population Description
Some participants discontinued as trial progressed.
Arm/Group Title Fluoxetine Placebo Open Lisdexamfetamine
Hide Arm/Group Description:
All participants initially enrolled in open lisdexamfetamine treatment, followed by randomization to adjunctive fluoxetine at week 4 continuing to week 12.
All participants initially enrolled in open lisdexamfetamine treatment, followed by randomization to adjunctive placebo at week 4 continuing through week 12.
All eligible participants initially titrated to optimal dose open lisdexamfetamine beginning at baseline (week 0) and continuing through study week 4.
Overall Number of Participants Analyzed 12 14 34
Least Squares Mean (Standard Error)
Unit of Measure: kg.
Baseline Number Analyzed 12 participants 14 participants 34 participants
37.96  (5.26) 47.26  (4.87) 42.59  (3.16)
Week 1 Number Analyzed 12 participants 14 participants 32 participants
37.29  (5.26) 46.39  (4.87) 41.83  (3.16)
Week 2 Number Analyzed 12 participants 14 participants 32 participants
36.96  (5.26) 45.56  (4.87) 41.29  (3.16)
Week 3 Number Analyzed 12 participants 14 participants 30 participants
36.55  (5.26) 45.06  (4.87) 40.73  (3.16)
Week 4 Number Analyzed 12 participants 14 participants 30 participants
36.20  (5.26) 45.22  (4.87) 40.67  (3.16)
Week 5 Number Analyzed 12 participants 14 participants 0 participants
36.08  (5.26) 44.80  (4.87)
Week 6 Number Analyzed 12 participants 14 participants 0 participants
35.73  (5.26) 44.34  (4.87)
Week 7 Number Analyzed 10 participants 14 participants 0 participants
35.30  (5.26) 44.72  (4.87)
Week 8 Number Analyzed 10 participants 13 participants 0 participants
35.08  (5.26) 44.08  (4.87)
Week 10 Number Analyzed 10 participants 11 participants 0 participants
34.61  (5.26) 44.16  (4.87)
Week 12 Number Analyzed 10 participants 11 participants 0 participants
34.73  (5.26) 43.05  (4.87)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fluoxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .21
Comments Group: F=1.56, df=1/222
Method Mixed Models Analysis
Comments Partial linear regression using mixed model, assessing outcome variable over time (baseline to study week 12) and time2 (study weeks 4-12).
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Fluoxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.0001
Comments Partial linear regression using mixed model, assessing outcome variable over time (baseline to study week 12) and time2 (study weeks 4-12).
Method Mixed Models Analysis
Comments Time: F=63.11, df=1/222
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Fluoxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .0004
Comments Partial linear regression using mixed model, assessing outcome variable over time (baseline to study week 12) and time2 (study weeks 4-12).
Method Mixed Models Analysis
Comments Time2: F=12.86, df=1/222
12.Secondary Outcome
Title Pulse
Hide Description Heart rate in beats per minute.
Time Frame Baseline through week 12.
Hide Outcome Measure Data
Hide Analysis Population Description
Some participants discontinued as trial progressed.
Arm/Group Title Fluoxetine Placebo Open Lisdexamfetamine
Hide Arm/Group Description:
All participants initially enrolled in open lisdexamfetamine treatment, followed by randomization to adjunctive fluoxetine at week 4 continuing to week 12.
All participants initially enrolled in open lisdexamfetamine treatment, followed by randomization to adjunctive placebo at week 4 continuing through week 12.
All eligible participants initially titrated to optimal dose open lisdexamfetamine beginning at baseline (week 0) and continuing through study week 4.
Overall Number of Participants Analyzed 12 14 34
Least Squares Mean (Standard Error)
Unit of Measure: beats per minute.
Baseline Number Analyzed 12 participants 14 participants 34 participants
82.28  (3.26) 84.64  (3.22) 80.84  (2.30)
Week 1 Number Analyzed 12 participants 14 participants 32 participants
95.08  (3.16) 85.21  (2.91) 88.15  (2.13)
Week 2 Number Analyzed 12 participants 14 participants 32 participants
88.25  (3.15) 81.64  (2.91) 84.33  (2.13)
Week 3 Number Analyzed 12 participants 14 participants 30 participants
96.32  (3.26) 85.79  (3.01) 90.71  (2.26)
Week 4 Number Analyzed 12 participants 14 participants 30 participants
93.08  (3.15) 83.21  (2.91) 88.45  (2.23)
Week 5 Number Analyzed 12 participants 14 participants 0 participants
94.16  (3.26) 83.00  (3.23)
Week 6 Number Analyzed 12 participants 14 participants 0 participants
87.33  (3.15) 90.55  (3.12)
Week 7 Number Analyzed 10 participants 14 participants 0 participants
91.94  (3.55) 90.00  (3.22)
Week 8 Number Analyzed 10 participants 13 participants 0 participants
87.17  (3.40) 85.10  (3.00)
Week 10 Number Analyzed 10 participants 11 participants 0 participants
95.83  (3.55) 82.90  (3.52)
Week 12 Number Analyzed 10 participants 11 participants 0 participants
92.75  (3.55) 90.62  (3.23)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fluoxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .02
Comments Group: F=5.42, df=1/223
Method Mixed Models Analysis
Comments Partial linear regression using mixed model, assessing outcome variable over time (baseline to study week 12) and time2 (study weeks 4-12).
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Fluoxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .18
Comments Partial linear regression using mixed model, assessing outcome variable over time (baseline to study week 12) and time2 (study weeks 4-12).
Method Mixed Models Analysis
Comments Time: F=1.77, df=1/223
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Fluoxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .49
Comments Partial linear regression using mixed model, assessing outcome variable over time (baseline to study week 12) and time2 (study weeks 4-12).
Method Mixed Models Analysis
Comments Time2: F=.47, df=1/223
13.Secondary Outcome
Title Systolic Blood Pressure
Hide Description Systolic Blood Pressure measured in mmHG
Time Frame Baseline through week 12.
Hide Outcome Measure Data
Hide Analysis Population Description
Some participants discontinued as trial progressed.
Arm/Group Title Fluoxetine Placebo Open Lisdexamfetamine
Hide Arm/Group Description:
All participants initially enrolled in open lisdexamfetamine treatment, followed by randomization to adjunctive fluoxetine at week 4 continuing to week 12.
All participants initially enrolled in open lisdexamfetamine treatment, followed by randomization to adjunctive placebo at week 4 continuing through week 12.
All eligible participants initially titrated to optimal dose open lisdexamfetamine beginning at baseline (week 0) and continuing through study week 4.
Overall Number of Participants Analyzed 12 14 34
Least Squares Mean (Standard Error)
Unit of Measure: mm Hg.
Baseline Number Analyzed 12 participants 14 participants 34 participants
107.85  (4.01) 106.68  (3.92) 107.40  (2.69)
Week 1 Number Analyzed 12 participants 14 participants 32 participants
99.42  (3.89) 111.71  (3.60) 106.03  (2.53)
Week 2 Number Analyzed 12 participants 14 participants 32 participants
104.83  (3.89) 110.36  (3.60) 107.48  (2.53)
Week 3 Number Analyzed 12 participants 14 participants 30 participants
109.20  (4.01) 109.89  (3.70) 110.73  (2.67)
Week 4 Number Analyzed 12 participants 14 participants 30 participants
112.00  (3.89) 110.07  (3.60) 111.77  (2.65)
Week 5 Number Analyzed 12 participants 14 participants 0 participants
109.57  (4.01) 104.20  (3.93)
Week 6 Number Analyzed 12 participants 14 participants 0 participants
111.58  (3.89) 108.98  (3.80)
Week 7 Number Analyzed 10 participants 14 participants 0 participants
112.04  (4.31) 112.80  (3.92)
Week 8 Number Analyzed 10 participants 13 participants 0 participants
111.20  (4.31) 110.94  (3.96)
Week 10 Number Analyzed 10 participants 11 participants 0 participants
112.25  (4.31) 105.67  (4.23)
Week 12 Number Analyzed 10 participants 11 participants 0 participants
116.15  (4.31) 113.90  (3.93)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fluoxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .90
Comments Group: F=.02, df=1/223
Method Mixed Models Analysis
Comments Partial linear regression using mixed model, assessing outcome variable over time (baseline to study week 12) and time2 (study weeks 4-12).
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Fluoxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .21
Comments Partial linear regression using mixed model, assessing outcome variable over time (baseline to study week 12) and time2 (study weeks 4-12).
Method Mixed Models Analysis
Comments Time: F=1.60, df=1/223
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Fluoxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .73
Comments Partial linear regression using mixed model, assessing outcome variable over time (baseline to study week 12) and time2 (study weeks 4-12).
Method Mixed Models Analysis
Comments Time2: F=.12, df=1/223
14.Secondary Outcome
Title Diastolic Blood Pressure
Hide Description Diastolic Blood pressure measured in mmHG.
Time Frame Baseline through week 12.
Hide Outcome Measure Data
Hide Analysis Population Description
Some participants discontinued as trial progressed.
Arm/Group Title Fluoxetine Placebo Open Lisdexamfetamine
Hide Arm/Group Description:
All participants initially enrolled in open lisdexamfetamine treatment, followed by randomization to adjunctive fluoxetine at week 4 continuing to week 12.
All participants initially enrolled in open lisdexamfetamine treatment, followed by randomization to adjunctive placebo at week 4 continuing through week 12.
All eligible participants initially titrated to optimal dose open lisdexamfetamine beginning at baseline (week 0) and continuing through study week 4.
Overall Number of Participants Analyzed 12 14 34
Least Squares Mean (Standard Error)
Unit of Measure: mm Hg.
Baseline Number Analyzed 12 participants 14 participants 34 participants
68.86  (2.36) 66.40  (2.34) 67.39  (1.56)
Week 1 Number Analyzed 12 participants 14 participants 32 participants
71.33  (2.27) 69.50  (2.10) 69.15  (1.45)
Week 2 Number Analyzed 12 participants 14 participants 32 participants
66.00  (2.27) 66.79  (2.10) 66.63  (1.45)
Week 3 Number Analyzed 12 participants 14 participants 30 participants
68.74  (2.36) 62.82  (2.18) 67.21  (1.56)
Week 4 Number Analyzed 12 participants 14 participants 30 participants
71.17  (2.27) 66.21  (2.10) 69.31  (1.53)
Week 5 Number Analyzed 12 participants 14 participants 0 participants
71.17  (2.36) 65.17  (2.34)
Week 6 Number Analyzed 12 participants 14 participants 0 participants
69.58  (2.27) 70.61  (2.25)
Week 7 Number Analyzed 10 participants 14 participants 0 participants
68.14  (2.58) 70.64  (2.34)
Week 8 Number Analyzed 10 participants 13 participants 0 participants
68.06  (2.46) 68.40  (2.17)
Week 10 Number Analyzed 10 participants 11 participants 0 participants
70.81  (2.58) 67.06  (2.56)
Week 12 Number Analyzed 10 participants 11 participants 0 participants
77.11  (2.58) 70.05  (2.34)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fluoxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .15
Comments Group: F=2.05, df=1/223
Method Mixed Models Analysis
Comments Partial linear regression using mixed model, assessing outcome variable over time (baseline to study week 12) and time2 (study weeks 4-12).
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Fluoxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .59
Comments Partial linear regression using mixed model, assessing outcome variable over time (baseline to study week 12) and time2 (study weeks 4-12).
Method Mixed Models Analysis
Comments Time: F=.29, df=1/223
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Fluoxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .14
Comments Partial linear regression using mixed model, assessing outcome variable over time (baseline to study week 12) and time2 (study weeks 4-12).
Method Mixed Models Analysis
Comments Time2: F=2.15, df=1/223
15.Other Pre-specified Outcome
Title Pediatric Anxiety Rating Scale
Hide Description Clinician completed dimensional assessment of anxiety symptoms.
Time Frame Baseline through week 12.
Outcome Measure Data Not Reported
16.Other Pre-specified Outcome
Title Children's Depression Rating Scale
Hide Description Clinician completed dimensional rating of depressive symptoms.
Time Frame Baseline through week 12.
Outcome Measure Data Not Reported
17.Other Pre-specified Outcome
Title Affective Reactivity Index Child Report
Hide Description Dimensional self-report of irritability, with total score 1-12, and higher scores indicating greater severity.
Time Frame Baseline through week 12.
Outcome Measure Data Not Reported
Time Frame Baseline through study week 12.
Adverse Event Reporting Description Adverse events were collected via structured ratings, including the Columbia Suicide Severity Rating Scale and the Side Effects Rating Scale.
 
Arm/Group Title Fluoxetine Placebo Open Lisdexamfetamine
Hide Arm/Group Description All participants initially enrolled in open lisdexamfetamine treatment, followed by randomization to adjunctive fluoxetine at week 4 and continuing though week 12. All participants initially enrolled in open lisdexamfetamine treatment, followed by randomization to adjunctive placebo at study week 4 and continuing through week 12. All eligible participants initially titrated to optimal dose open lisdexamfetamine from baseline through week 4.
All-Cause Mortality
Fluoxetine Placebo Open Lisdexamfetamine
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/12 (0.00%)      0/14 (0.00%)      0/34 (0.00%)    
Hide Serious Adverse Events
Fluoxetine Placebo Open Lisdexamfetamine
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/12 (0.00%)      0/14 (0.00%)      0/34 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Fluoxetine Placebo Open Lisdexamfetamine
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   8/12 (66.67%)      10/14 (71.43%)      30/34 (88.24%)    
Cardiac disorders       
Heart skips beats  [1]  0/12 (0.00%)  0 2/14 (14.29%)  2 0/34 (0.00%)  0
Racing heart  [1]  0/12 (0.00%)  0 2/14 (14.29%)  2 2/34 (5.88%)  2
Chest pain  [1]  1/12 (8.33%)  1 0/14 (0.00%)  0 2/34 (5.88%)  2
Gastrointestinal disorders       
Stomach pain/ache  [1]  0/12 (0.00%)  0 1/14 (7.14%)  1 4/34 (11.76%)  5
Nausea/vomiting  [1]  1/12 (8.33%)  1 1/14 (7.14%)  1 2/34 (5.88%)  3
Diarrhea  [1]  2/12 (16.67%)  2 1/14 (7.14%)  1 3/34 (8.82%)  3
Constipation  [1]  3/12 (25.00%)  3 0/14 (0.00%)  0 0/34 (0.00%)  0
Heartburn  [1]  1/12 (8.33%)  1 0/14 (0.00%)  0 0/34 (0.00%)  0
General disorders       
Feeling drowsy/sleep  [1]  1/12 (8.33%)  2 1/14 (7.14%)  1 4/34 (11.76%)  5
Dry mouth  [1]  0/12 (0.00%)  0 3/14 (21.43%)  3 4/34 (11.76%)  6
Restless/uncomfortable urge to move  [1]  1/12 (8.33%)  1 2/14 (14.29%)  4 1/34 (2.94%)  2
Decreased appetite  [1]  7/12 (58.33%)  24 6/14 (42.86%)  11 21/34 (61.76%)  51
Nervous system disorders       
Headache  [1]  1/12 (8.33%)  1 1/14 (7.14%)  1 5/34 (14.71%)  8
Excessive sweating  [1]  0/12 (0.00%)  0 1/14 (7.14%)  1 3/34 (8.82%)  3
Tremor/shakiness  [1]  0/12 (0.00%)  0 0/14 (0.00%)  0 1/34 (2.94%)  2
Tics  [1]  2/12 (16.67%)  2 3/14 (21.43%)  3 4/34 (11.76%)  7
Bites fingernails  [1]  3/12 (25.00%)  5 2/14 (14.29%)  6 5/34 (14.71%)  7
Psychiatric disorders       
Wish to be dead  [2]  1/12 (8.33%)  3 2/14 (14.29%)  2 0/34 (0.00%)  0
Suicidal ideation without intent  [2]  1/12 (8.33%)  1 0/14 (0.00%)  0 0/34 (0.00%)  0
Trouble sleeping  [1]  1/12 (8.33%)  1 4/14 (28.57%)  6 9/34 (26.47%)  15
Sleeplessness  [1]  1/12 (8.33%)  6 2/14 (14.29%)  4 4/34 (11.76%)  9
Nightmares  [1]  0/12 (0.00%)  0 2/14 (14.29%)  3 1/34 (2.94%)  1
Euphoria  [1]  1/12 (8.33%)  1 1/14 (7.14%)  1 1/34 (2.94%)  1
Talks less with others  [1]  1/12 (8.33%)  1 2/14 (14.29%)  2 1/34 (2.94%)  1
Prone to crying  [1]  0/12 (0.00%)  0 3/14 (21.43%)  3 6/34 (17.65%)  9
Renal and urinary disorders       
Frequent urination  [1]  0/12 (0.00%)  0 0/14 (0.00%)  0 1/34 (2.94%)  2
Indicates events were collected by systematic assessment
[1]
Clinically significant symptom with post baseline onset based on parent completed Physical Symptoms Checklist.
[2]
Endorsed on Columbia Suicide Severity Rating Scale
Study was designed as an initial feasibility and proof of concept trial. Initial power analysis suggested need to randomize N=50 participants. Recruitment was much more difficult than expected, leading to small sample size.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: James J. McGough, M.D.
Organization: University of California, Los Angeles
Phone: 310-794-7841
EMail: jmcgough@mednet.ucla.edu
Layout table for additonal information
Responsible Party: James McGough, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT01714310    
Other Study ID Numbers: U01MH093582 ( U.S. NIH Grant/Contract )
U01MH093582 ( U.S. NIH Grant/Contract )
First Submitted: October 20, 2012
First Posted: October 25, 2012
Results First Submitted: December 7, 2017
Results First Posted: February 26, 2018
Last Update Posted: February 26, 2018