Trial Outcomes & Findings for Characterization and Sequential Pharmacotherapy of Severe Mood Dysregulation (NCT NCT01714310)
NCT ID: NCT01714310
Last Updated: 2018-02-26
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
34 participants
Primary outcome timeframe
Baseline through week 12.
Results posted on
2018-02-26
Participant Flow
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
Participant milestones
| Measure |
Fluoxetine
All participants initially enrolled in open lisdexamfetamine treatment, followed by randomization to adjunctive fluoxetine at study week 4 and continuing to study week 12.
|
Placebo
All participants initially enrolled in open lisdexamfetamine treatment, followed by randomization to adjunctive placebo at study week 4 and continuing through study week 12.
|
Open Lisdexamfetamine
All eligible participants initially titrated to optimal dose open lisdexamfetamine beginning at baseline (week 0) and continuing to the end of study week 4.
|
|---|---|---|---|
|
Open Lisdexamfetamine Titration
STARTED
|
0
|
0
|
34
|
|
Open Lisdexamfetamine Titration
COMPLETED
|
0
|
0
|
30
|
|
Open Lisdexamfetamine Titration
NOT COMPLETED
|
0
|
0
|
4
|
|
Double Blind Adjunctive Treatment
STARTED
|
12
|
14
|
0
|
|
Double Blind Adjunctive Treatment
COMPLETED
|
10
|
11
|
0
|
|
Double Blind Adjunctive Treatment
NOT COMPLETED
|
2
|
3
|
0
|
Reasons for withdrawal
| Measure |
Fluoxetine
All participants initially enrolled in open lisdexamfetamine treatment, followed by randomization to adjunctive fluoxetine at study week 4 and continuing to study week 12.
|
Placebo
All participants initially enrolled in open lisdexamfetamine treatment, followed by randomization to adjunctive placebo at study week 4 and continuing through study week 12.
|
Open Lisdexamfetamine
All eligible participants initially titrated to optimal dose open lisdexamfetamine beginning at baseline (week 0) and continuing to the end of study week 4.
|
|---|---|---|---|
|
Open Lisdexamfetamine Titration
Protocol Violation
|
0
|
0
|
1
|
|
Open Lisdexamfetamine Titration
Adverse Event
|
0
|
0
|
3
|
|
Double Blind Adjunctive Treatment
Adverse Event
|
1
|
1
|
0
|
|
Double Blind Adjunctive Treatment
Protocol Violation
|
1
|
2
|
0
|
Baseline Characteristics
Characterization and Sequential Pharmacotherapy of Severe Mood Dysregulation
Baseline characteristics by cohort
| Measure |
Open Lisdexamfetamine
n=34 Participants
All eligible participants initially titrated to optimal dose open lisdexamfetamine from baseline through week 3.
|
Fluoxetine
n=12 Participants
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.
|
Placebo
n=14 Participants
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
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
10.24 years
STANDARD_DEVIATION 2.58 • n=5 Participants
|
9.97 years
STANDARD_DEVIATION 2.30 • n=7 Participants
|
10.22 years
STANDARD_DEVIATION 2.74 • n=5 Participants
|
NA years
STANDARD_DEVIATION NA • n=4 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
37 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
28 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
49 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
27 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
48 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Wechsler Abbreviated Scale of Intelligence
|
103.16 units on a scale
STANDARD_DEVIATION 14.30 • n=5 Participants
|
105.58 units on a scale
STANDARD_DEVIATION 15.56 • n=7 Participants
|
101.69 units on a scale
STANDARD_DEVIATION 14.34 • n=5 Participants
|
NA units on a scale
STANDARD_DEVIATION NA • n=4 Participants
|
|
Clinical Global Impression SMD Severity
|
4.82 units on a scale
STANDARD_DEVIATION .52 • n=5 Participants
|
4.75 units on a scale
STANDARD_DEVIATION .46 • n=7 Participants
|
4.83 units on a scale
STANDARD_DEVIATION .72 • n=5 Participants
|
NA units on a scale
STANDARD_DEVIATION NA • n=4 Participants
|
|
Affective Reactivity Index Parent Report
|
8.91 units on a scale
STANDARD_DEVIATION 2.47 • n=5 Participants
|
10.00 units on a scale
STANDARD_DEVIATION 1.95 • n=7 Participants
|
8.57 units on a scale
STANDARD_DEVIATION 2.17 • n=5 Participants
|
NA units on a scale
STANDARD_DEVIATION NA • n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline through week 12.Population: Compares groups lisdexamfetamine plus fluoxetine vs. lisdexamfetamine plus placebo over 12 week trial. Some participants discontinued as trial progressed.
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.
Outcome measures
| Measure |
Fluoxetine
n=12 Participants
All participants initially enrolled in open lisdexamfetamine treatment, followed by randomization to adjunctive fluoxetine at week 4 continuing to week 12.
|
Placebo
n=14 Participants
All participants initially enrolled in open lisdexamfetamine treatment, followed by randomization to adjunctive placebo at week 4 continuing through week 12.
|
Open Lisdexamfetamine
n=34 Participants
All eligible participants initially titrated to optimal dose open lisdexamfetamine starting at baseline (week 0) and continuing through study week.
|
|---|---|---|---|
|
Clinical Global Impression-Severity-Severe Mood Dysregulation
Baseline
|
4.91 units on a scale
Standard Error .53
|
3.62 units on a scale
Standard Error .48
|
4.30 units on a scale
Standard Error .32
|
|
Clinical Global Impression-Severity-Severe Mood Dysregulation
Week 4
|
4.42 units on a scale
Standard Error .34
|
4.57 units on a scale
Standard Error .31
|
4.31 units on a scale
Standard Error .19
|
|
Clinical Global Impression-Severity-Severe Mood Dysregulation
Week 5
|
4.15 units on a scale
Standard Error .36
|
3.51 units on a scale
Standard Error .32
|
—
|
|
Clinical Global Impression-Severity-Severe Mood Dysregulation
Week 6
|
3.67 units on a scale
Standard Error .34
|
3.90 units on a scale
Standard Error .33
|
—
|
|
Clinical Global Impression-Severity-Severe Mood Dysregulation
Week 7
|
3.61 units on a scale
Standard Error .37
|
3.59 units on a scale
Standard Error .34
|
—
|
|
Clinical Global Impression-Severity-Severe Mood Dysregulation
Week 8
|
3.42 units on a scale
Standard Error .39
|
3.37 units on a scale
Standard Error .34
|
—
|
|
Clinical Global Impression-Severity-Severe Mood Dysregulation
Week 10
|
3.45 units on a scale
Standard Error .42
|
3.11 units on a scale
Standard Error .35
|
—
|
|
Clinical Global Impression-Severity-Severe Mood Dysregulation
Week 12
|
3.51 units on a scale
Standard Error .38
|
3.30 units on a scale
Standard Error .36
|
—
|
SECONDARY outcome
Timeframe: Baseline through week 12.Population: Participants discontinued as trial progressed.
A dimensional rating of ADHD symptoms, with scores ranging from 0 - 54, and higher scores indicating greater symptom severity.
Outcome measures
| Measure |
Fluoxetine
n=12 Participants
All participants initially enrolled in open lisdexamfetamine treatment, followed by randomization to adjunctive fluoxetine at week 4 continuing to week 12.
|
Placebo
n=14 Participants
All participants initially enrolled in open lisdexamfetamine treatment, followed by randomization to adjunctive placebo at week 4 continuing through week 12.
|
Open Lisdexamfetamine
n=34 Participants
All eligible participants initially titrated to optimal dose open lisdexamfetamine starting at baseline (week 0) and continuing through study week.
|
|---|---|---|---|
|
ADHD-IV Rating Scale
Baseline
|
34.50 units on a scale
Standard Error 1.97
|
34.31 units on a scale
Standard Error 1.87
|
34.20 units on a scale
Standard Error 1.15
|
|
ADHD-IV Rating Scale
Week 4
|
14.92 units on a scale
Standard Error 1.97
|
18.64 units on a scale
Standard Error 1.82
|
16.59 units on a scale
Standard Error 1.21
|
|
ADHD-IV Rating Scale
Week 12
|
16.29 units on a scale
Standard Error 2.10
|
11.93 units on a scale
Standard Error 1.99
|
—
|
SECONDARY outcome
Timeframe: Baseline through week 3.Population: Participants were assessed on this measure only during the Open Lisdexamfetamine phase. Some participant discontinued as trial progressed.
Parent completed dimensional measure of ADHD symptoms, with score range from 0 - 30 and higher scores indicating more severe symptoms.
Outcome measures
| Measure |
Fluoxetine
All participants initially enrolled in open lisdexamfetamine treatment, followed by randomization to adjunctive fluoxetine at week 4 continuing to week 12.
|
Placebo
All participants initially enrolled in open lisdexamfetamine treatment, followed by randomization to adjunctive placebo at week 4 continuing through week 12.
|
Open Lisdexamfetamine
n=34 Participants
All eligible participants initially titrated to optimal dose open lisdexamfetamine starting at baseline (week 0) and continuing through study week.
|
|---|---|---|---|
|
Conners Parent Global Index
Baseline
|
—
|
—
|
15.91 units on a scale
Standard Error .82
|
|
Conners Parent Global Index
Week 1
|
—
|
—
|
9.54 units on a scale
Standard Error .82
|
|
Conners Parent Global Index
Week 2
|
—
|
—
|
10.60 units on a scale
Standard Error .85
|
|
Conners Parent Global Index
Week 3
|
—
|
—
|
8.60 units on a scale
Standard Error .87
|
SECONDARY outcome
Timeframe: Baseline to week 3.Population: Participants were assessed on this measure only during the Open Lisdexamfetamine phase. Some participants discontinues as trial progressed.
A sub scale of the Conners Global Index, with scores ranging from 0 - 12, with higher scores indicating more impairment.
Outcome measures
| Measure |
Fluoxetine
All participants initially enrolled in open lisdexamfetamine treatment, followed by randomization to adjunctive fluoxetine at week 4 continuing to week 12.
|
Placebo
All participants initially enrolled in open lisdexamfetamine treatment, followed by randomization to adjunctive placebo at week 4 continuing through week 12.
|
Open Lisdexamfetamine
n=34 Participants
All eligible participants initially titrated to optimal dose open lisdexamfetamine starting at baseline (week 0) and continuing through study week.
|
|---|---|---|---|
|
Conners Global Index Emotional Lability Subscale - Parent Report
Baseline
|
—
|
—
|
8.81 units on a scale
Standard Error .52
|
|
Conners Global Index Emotional Lability Subscale - Parent Report
Week 1
|
—
|
—
|
5.90 units on a scale
Standard Error .52
|
|
Conners Global Index Emotional Lability Subscale - Parent Report
Week 2
|
—
|
—
|
6.33 units on a scale
Standard Error .53
|
|
Conners Global Index Emotional Lability Subscale - Parent Report
Week 3
|
—
|
—
|
5.45 units on a scale
Standard Error .55
|
SECONDARY outcome
Timeframe: Baseline through week 3.Population: Participants were assessed on this measure only during the Open Lisdexamfetamine phase. Some participants discontinued as trial progressed.
A dimensional parent report measure of restless-impulsive symptoms, with scores ranging from 0 to 21, and higher scores indicating greater impairment.
Outcome measures
| Measure |
Fluoxetine
All participants initially enrolled in open lisdexamfetamine treatment, followed by randomization to adjunctive fluoxetine at week 4 continuing to week 12.
|
Placebo
All participants initially enrolled in open lisdexamfetamine treatment, followed by randomization to adjunctive placebo at week 4 continuing through week 12.
|
Open Lisdexamfetamine
n=34 Participants
All eligible participants initially titrated to optimal dose open lisdexamfetamine starting at baseline (week 0) and continuing through study week.
|
|---|---|---|---|
|
Conners Global Index Restless-Impulsive Subscale Parent Report
Baseline
|
—
|
—
|
15.91 units on a scale
Standard Error .82
|
|
Conners Global Index Restless-Impulsive Subscale Parent Report
Week 1
|
—
|
—
|
9.55 units on a scale
Standard Error .82
|
|
Conners Global Index Restless-Impulsive Subscale Parent Report
Week 2
|
—
|
—
|
10.60 units on a scale
Standard Error .85
|
|
Conners Global Index Restless-Impulsive Subscale Parent Report
Week 3
|
—
|
—
|
8.60 units on a scale
Standard Error .87
|
SECONDARY outcome
Timeframe: Baseline through week 3.Population: Participants were assessed on this measure only during the Open Lisdexamfetamine phase. Some participants discontinued as trial progressed.
Teacher completed dimensional measure of ADHD symptoms, with scores ranging from 0 - 30, and higher scores indicating more severe impairment.
Outcome measures
| Measure |
Fluoxetine
All participants initially enrolled in open lisdexamfetamine treatment, followed by randomization to adjunctive fluoxetine at week 4 continuing to week 12.
|
Placebo
All participants initially enrolled in open lisdexamfetamine treatment, followed by randomization to adjunctive placebo at week 4 continuing through week 12.
|
Open Lisdexamfetamine
n=34 Participants
All eligible participants initially titrated to optimal dose open lisdexamfetamine starting at baseline (week 0) and continuing through study week.
|
|---|---|---|---|
|
Conners Teacher Global Index
Baseline
|
—
|
—
|
18.13 units on a scale
Standard Error 1.87
|
|
Conners Teacher Global Index
Week 1
|
—
|
—
|
13.21 units on a scale
Standard Error 1.87
|
|
Conners Teacher Global Index
Week 2
|
—
|
—
|
10.18 units on a scale
Standard Error 1.93
|
|
Conners Teacher Global Index
Week 3
|
—
|
—
|
8.31 units on a scale
Standard Error 1.61
|
SECONDARY outcome
Timeframe: Baseline through week 12.Population: Some participants discontinued as trial progressed.
A parent completed dimensional measure of emotional reactivity, with scores ranging from 0-12, and higher scores indicating greater severity.
Outcome measures
| Measure |
Fluoxetine
n=12 Participants
All participants initially enrolled in open lisdexamfetamine treatment, followed by randomization to adjunctive fluoxetine at week 4 continuing to week 12.
|
Placebo
n=14 Participants
All participants initially enrolled in open lisdexamfetamine treatment, followed by randomization to adjunctive placebo at week 4 continuing through week 12.
|
Open Lisdexamfetamine
n=34 Participants
All eligible participants initially titrated to optimal dose open lisdexamfetamine starting at baseline (week 0) and continuing through study week.
|
|---|---|---|---|
|
Affective Reactivity Index - Parent Report
Baseline
|
10.00 units on a scale
Standard Error .96
|
8.57 units on a scale
Standard Error .88
|
9.29 units on a scale
Standard Error .92
|
|
Affective Reactivity Index - Parent Report
Week 4
|
7.58 units on a scale
Standard Error .96
|
7.71 units on a scale
Standard Error .88
|
6.87 units on a scale
Standard Error .59
|
|
Affective Reactivity Index - Parent Report
Week 5
|
6.58 units on a scale
Standard Error .96
|
6.21 units on a scale
Standard Error .88
|
—
|
|
Affective Reactivity Index - Parent Report
Week 6
|
6.42 units on a scale
Standard Error .96
|
5.32 units on a scale
Standard Error .90
|
—
|
|
Affective Reactivity Index - Parent Report
Week 7
|
6.69 units on a scale
Standard Error 1.00
|
6.49 units on a scale
Standard Error 1.00
|
—
|
|
Affective Reactivity Index - Parent Report
Week 8
|
6.49 units on a scale
Standard Error 1.00
|
5.62 units on a scale
Standard Error .90
|
—
|
|
Affective Reactivity Index - Parent Report
Week 10
|
6.74 units on a scale
Standard Error 1.07
|
4.89 units on a scale
Standard Error .97
|
—
|
|
Affective Reactivity Index - Parent Report
Week 12
|
6.39 units on a scale
Standard Error 1.00
|
5.30 units on a scale
Standard Error .94
|
—
|
SECONDARY outcome
Timeframe: Baseline through week 12.Population: Some participants discontinued as trial progressed.
A parent rated retrospective dimensional assessment of oppositional and aggressive behaviors, with scores ranging from 0-40, and higher scores indicating greater severity.
Outcome measures
| Measure |
Fluoxetine
n=12 Participants
All participants initially enrolled in open lisdexamfetamine treatment, followed by randomization to adjunctive fluoxetine at week 4 continuing to week 12.
|
Placebo
n=14 Participants
All participants initially enrolled in open lisdexamfetamine treatment, followed by randomization to adjunctive placebo at week 4 continuing through week 12.
|
Open Lisdexamfetamine
n=34 Participants
All eligible participants initially titrated to optimal dose open lisdexamfetamine starting at baseline (week 0) and continuing through study week.
|
|---|---|---|---|
|
Revised Modified Overt Aggression Scale - Total Score
Baseline
|
22.23 units on a scale
Standard Error 4.44
|
33.68 units on a scale
Standard Error 4.08
|
26.03 units on a scale
Standard Error 2.61
|
|
Revised Modified Overt Aggression Scale - Total Score
Week 4
|
14.44 units on a scale
Standard Error 4.30
|
25.35 units on a scale
Standard Error 3.98
|
17.93 units on a scale
Standard Error 2.67
|
|
Revised Modified Overt Aggression Scale - Total Score
Week 5
|
13.72 units on a scale
Standard Error 4.31
|
20.60 units on a scale
Standard Error 4.19
|
—
|
|
Revised Modified Overt Aggression Scale - Total Score
Week 6
|
10.00 units on a scale
Standard Error 4.20
|
20.55 units on a scale
Standard Error 3.98
|
—
|
|
Revised Modified Overt Aggression Scale - Total Score
Week 7
|
13.19 units on a scale
Standard Error 4.45
|
21.89 units on a scale
Standard Error 4.32
|
—
|
|
Revised Modified Overt Aggression Scale - Total Score
Week 8
|
14.09 units on a scale
Standard Error 4.45
|
21.33 units on a scale
Standard Error 4.08
|
—
|
|
Revised Modified Overt Aggression Scale - Total Score
Week 10
|
12.61 units on a scale
Standard Error 4.60
|
17.68 units on a scale
Standard Error 4.47
|
—
|
|
Revised Modified Overt Aggression Scale - Total Score
Week 12
|
14.29 units on a scale
Standard Error 4.45
|
18.34 units on a scale
Standard Error 4.32
|
—
|
SECONDARY outcome
Timeframe: Percentage improved at week 4 for Open Lisdexamfetamine group and at week 12 for fluoxetine and placebo groups.Population: Some participants discontinued as trial progressed.
Percentage improved by treatment group
Outcome measures
| Measure |
Fluoxetine
n=10 Participants
All participants initially enrolled in open lisdexamfetamine treatment, followed by randomization to adjunctive fluoxetine at week 4 continuing to week 12.
|
Placebo
n=11 Participants
All participants initially enrolled in open lisdexamfetamine treatment, followed by randomization to adjunctive placebo at week 4 continuing through week 12.
|
Open Lisdexamfetamine
n=34 Participants
All eligible participants initially titrated to optimal dose open lisdexamfetamine starting at baseline (week 0) and continuing through study week.
|
|---|---|---|---|
|
Clinical Global Impression - Improvement
|
7 Participants
|
7 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: Baseline through week 12.Population: Participants discontinued as trial progressed.
A dimensional measure assessed in cms.
Outcome measures
| Measure |
Fluoxetine
n=12 Participants
All participants initially enrolled in open lisdexamfetamine treatment, followed by randomization to adjunctive fluoxetine at week 4 continuing to week 12.
|
Placebo
n=14 Participants
All participants initially enrolled in open lisdexamfetamine treatment, followed by randomization to adjunctive placebo at week 4 continuing through week 12.
|
Open Lisdexamfetamine
n=34 Participants
All eligible participants initially titrated to optimal dose open lisdexamfetamine starting at baseline (week 0) and continuing through study week.
|
|---|---|---|---|
|
Height
Baseline
|
140.25 cm.
Standard Error 3.82
|
144.63 cm.
Standard Error 3.53
|
142.37 cm.
Standard Error 2.12
|
|
Height
Week 1
|
140.05 cm.
Standard Error 3.81
|
144.76 cm.
Standard Error 3.53
|
142.35 cm.
Standard Error 2.12
|
|
Height
Week 2
|
139.95 cm.
Standard Error 3.82
|
144.81 cm.
Standard Error 3.53
|
142.43 cm.
Standard Error 2.12
|
|
Height
Week 3
|
140.26 cm.
Standard Error 3.82
|
144.88 cm.
Standard Error 3.53
|
142.59 cm.
Standard Error 2.12
|
|
Height
Week 4
|
140.56 cm.
Standard Error 3.82
|
144.54 cm.
Standard Error 3.53
|
142.59 cm.
Standard Error 2.12
|
|
Height
Week 5
|
140.11 cm.
Standard Error 3.82
|
144.82 cm.
Standard Error 3.53
|
—
|
|
Height
Week 6
|
140.21 cm.
Standard Error 3.82
|
145.44 cm.
Standard Error 3.53
|
—
|
|
Height
Week 7
|
140.55 cm.
Standard Error 3.82
|
145.14 cm.
Standard Error 3.53
|
—
|
|
Height
Week 8
|
140.81 cm.
Standard Error 3.82
|
144.98 cm.
Standard Error 3.53
|
—
|
|
Height
Week 10
|
140.83 cm.
Standard Error 3.82
|
145.30 cm.
Standard Error 3.54
|
—
|
|
Height
Week 12
|
140.98 cm.
Standard Error 3.82
|
145.60 cm.
Standard Error 3.53
|
—
|
SECONDARY outcome
Timeframe: Baseline through week 12.Population: Some participants discontinued as trial progressed.
Weight in kg.
Outcome measures
| Measure |
Fluoxetine
n=12 Participants
All participants initially enrolled in open lisdexamfetamine treatment, followed by randomization to adjunctive fluoxetine at week 4 continuing to week 12.
|
Placebo
n=14 Participants
All participants initially enrolled in open lisdexamfetamine treatment, followed by randomization to adjunctive placebo at week 4 continuing through week 12.
|
Open Lisdexamfetamine
n=34 Participants
All eligible participants initially titrated to optimal dose open lisdexamfetamine starting at baseline (week 0) and continuing through study week.
|
|---|---|---|---|
|
Weight
Baseline
|
37.96 kg.
Standard Error 5.26
|
47.26 kg.
Standard Error 4.87
|
42.59 kg.
Standard Error 3.16
|
|
Weight
Week 1
|
37.29 kg.
Standard Error 5.26
|
46.39 kg.
Standard Error 4.87
|
41.83 kg.
Standard Error 3.16
|
|
Weight
Week 2
|
36.96 kg.
Standard Error 5.26
|
45.56 kg.
Standard Error 4.87
|
41.29 kg.
Standard Error 3.16
|
|
Weight
Week 3
|
36.55 kg.
Standard Error 5.26
|
45.06 kg.
Standard Error 4.87
|
40.73 kg.
Standard Error 3.16
|
|
Weight
Week 4
|
36.20 kg.
Standard Error 5.26
|
45.22 kg.
Standard Error 4.87
|
40.67 kg.
Standard Error 3.16
|
|
Weight
Week 5
|
36.08 kg.
Standard Error 5.26
|
44.80 kg.
Standard Error 4.87
|
—
|
|
Weight
Week 6
|
35.73 kg.
Standard Error 5.26
|
44.34 kg.
Standard Error 4.87
|
—
|
|
Weight
Week 7
|
35.30 kg.
Standard Error 5.26
|
44.72 kg.
Standard Error 4.87
|
—
|
|
Weight
Week 8
|
35.08 kg.
Standard Error 5.26
|
44.08 kg.
Standard Error 4.87
|
—
|
|
Weight
Week 10
|
34.61 kg.
Standard Error 5.26
|
44.16 kg.
Standard Error 4.87
|
—
|
|
Weight
Week 12
|
34.73 kg.
Standard Error 5.26
|
43.05 kg.
Standard Error 4.87
|
—
|
SECONDARY outcome
Timeframe: Baseline through week 12.Population: Some participants discontinued as trial progressed.
Heart rate in beats per minute.
Outcome measures
| Measure |
Fluoxetine
n=12 Participants
All participants initially enrolled in open lisdexamfetamine treatment, followed by randomization to adjunctive fluoxetine at week 4 continuing to week 12.
|
Placebo
n=14 Participants
All participants initially enrolled in open lisdexamfetamine treatment, followed by randomization to adjunctive placebo at week 4 continuing through week 12.
|
Open Lisdexamfetamine
n=34 Participants
All eligible participants initially titrated to optimal dose open lisdexamfetamine starting at baseline (week 0) and continuing through study week.
|
|---|---|---|---|
|
Pulse
Baseline
|
82.28 beats per minute.
Standard Error 3.26
|
84.64 beats per minute.
Standard Error 3.22
|
80.84 beats per minute.
Standard Error 2.30
|
|
Pulse
Week 1
|
95.08 beats per minute.
Standard Error 3.16
|
85.21 beats per minute.
Standard Error 2.91
|
88.15 beats per minute.
Standard Error 2.13
|
|
Pulse
Week 2
|
88.25 beats per minute.
Standard Error 3.15
|
81.64 beats per minute.
Standard Error 2.91
|
84.33 beats per minute.
Standard Error 2.13
|
|
Pulse
Week 3
|
96.32 beats per minute.
Standard Error 3.26
|
85.79 beats per minute.
Standard Error 3.01
|
90.71 beats per minute.
Standard Error 2.26
|
|
Pulse
Week 4
|
93.08 beats per minute.
Standard Error 3.15
|
83.21 beats per minute.
Standard Error 2.91
|
88.45 beats per minute.
Standard Error 2.23
|
|
Pulse
Week 5
|
94.16 beats per minute.
Standard Error 3.26
|
83.00 beats per minute.
Standard Error 3.23
|
—
|
|
Pulse
Week 6
|
87.33 beats per minute.
Standard Error 3.15
|
90.55 beats per minute.
Standard Error 3.12
|
—
|
|
Pulse
Week 7
|
91.94 beats per minute.
Standard Error 3.55
|
90.00 beats per minute.
Standard Error 3.22
|
—
|
|
Pulse
Week 8
|
87.17 beats per minute.
Standard Error 3.40
|
85.10 beats per minute.
Standard Error 3.00
|
—
|
|
Pulse
Week 10
|
95.83 beats per minute.
Standard Error 3.55
|
82.90 beats per minute.
Standard Error 3.52
|
—
|
|
Pulse
Week 12
|
92.75 beats per minute.
Standard Error 3.55
|
90.62 beats per minute.
Standard Error 3.23
|
—
|
SECONDARY outcome
Timeframe: Baseline through week 12.Population: Some participants discontinued as trial progressed.
Systolic Blood Pressure measured in mmHG
Outcome measures
| Measure |
Fluoxetine
n=12 Participants
All participants initially enrolled in open lisdexamfetamine treatment, followed by randomization to adjunctive fluoxetine at week 4 continuing to week 12.
|
Placebo
n=14 Participants
All participants initially enrolled in open lisdexamfetamine treatment, followed by randomization to adjunctive placebo at week 4 continuing through week 12.
|
Open Lisdexamfetamine
n=34 Participants
All eligible participants initially titrated to optimal dose open lisdexamfetamine starting at baseline (week 0) and continuing through study week.
|
|---|---|---|---|
|
Systolic Blood Pressure
Baseline
|
107.85 mm Hg.
Standard Error 4.01
|
106.68 mm Hg.
Standard Error 3.92
|
107.40 mm Hg.
Standard Error 2.69
|
|
Systolic Blood Pressure
Week 1
|
99.42 mm Hg.
Standard Error 3.89
|
111.71 mm Hg.
Standard Error 3.60
|
106.03 mm Hg.
Standard Error 2.53
|
|
Systolic Blood Pressure
Week 2
|
104.83 mm Hg.
Standard Error 3.89
|
110.36 mm Hg.
Standard Error 3.60
|
107.48 mm Hg.
Standard Error 2.53
|
|
Systolic Blood Pressure
Week 3
|
109.20 mm Hg.
Standard Error 4.01
|
109.89 mm Hg.
Standard Error 3.70
|
110.73 mm Hg.
Standard Error 2.67
|
|
Systolic Blood Pressure
Week 4
|
112.00 mm Hg.
Standard Error 3.89
|
110.07 mm Hg.
Standard Error 3.60
|
111.77 mm Hg.
Standard Error 2.65
|
|
Systolic Blood Pressure
Week 5
|
109.57 mm Hg.
Standard Error 4.01
|
104.20 mm Hg.
Standard Error 3.93
|
—
|
|
Systolic Blood Pressure
Week 6
|
111.58 mm Hg.
Standard Error 3.89
|
108.98 mm Hg.
Standard Error 3.80
|
—
|
|
Systolic Blood Pressure
Week 7
|
112.04 mm Hg.
Standard Error 4.31
|
112.80 mm Hg.
Standard Error 3.92
|
—
|
|
Systolic Blood Pressure
Week 8
|
111.20 mm Hg.
Standard Error 4.31
|
110.94 mm Hg.
Standard Error 3.96
|
—
|
|
Systolic Blood Pressure
Week 10
|
112.25 mm Hg.
Standard Error 4.31
|
105.67 mm Hg.
Standard Error 4.23
|
—
|
|
Systolic Blood Pressure
Week 12
|
116.15 mm Hg.
Standard Error 4.31
|
113.90 mm Hg.
Standard Error 3.93
|
—
|
SECONDARY outcome
Timeframe: Baseline through week 12.Population: Some participants discontinued as trial progressed.
Diastolic Blood pressure measured in mmHG.
Outcome measures
| Measure |
Fluoxetine
n=12 Participants
All participants initially enrolled in open lisdexamfetamine treatment, followed by randomization to adjunctive fluoxetine at week 4 continuing to week 12.
|
Placebo
n=14 Participants
All participants initially enrolled in open lisdexamfetamine treatment, followed by randomization to adjunctive placebo at week 4 continuing through week 12.
|
Open Lisdexamfetamine
n=34 Participants
All eligible participants initially titrated to optimal dose open lisdexamfetamine starting at baseline (week 0) and continuing through study week.
|
|---|---|---|---|
|
Diastolic Blood Pressure
Baseline
|
68.86 mm Hg.
Standard Error 2.36
|
66.40 mm Hg.
Standard Error 2.34
|
67.39 mm Hg.
Standard Error 1.56
|
|
Diastolic Blood Pressure
Week 1
|
71.33 mm Hg.
Standard Error 2.27
|
69.50 mm Hg.
Standard Error 2.10
|
69.15 mm Hg.
Standard Error 1.45
|
|
Diastolic Blood Pressure
Week 2
|
66.00 mm Hg.
Standard Error 2.27
|
66.79 mm Hg.
Standard Error 2.10
|
66.63 mm Hg.
Standard Error 1.45
|
|
Diastolic Blood Pressure
Week 3
|
68.74 mm Hg.
Standard Error 2.36
|
62.82 mm Hg.
Standard Error 2.18
|
67.21 mm Hg.
Standard Error 1.56
|
|
Diastolic Blood Pressure
Week 4
|
71.17 mm Hg.
Standard Error 2.27
|
66.21 mm Hg.
Standard Error 2.10
|
69.31 mm Hg.
Standard Error 1.53
|
|
Diastolic Blood Pressure
Week 5
|
71.17 mm Hg.
Standard Error 2.36
|
65.17 mm Hg.
Standard Error 2.34
|
—
|
|
Diastolic Blood Pressure
Week 6
|
69.58 mm Hg.
Standard Error 2.27
|
70.61 mm Hg.
Standard Error 2.25
|
—
|
|
Diastolic Blood Pressure
Week 7
|
68.14 mm Hg.
Standard Error 2.58
|
70.64 mm Hg.
Standard Error 2.34
|
—
|
|
Diastolic Blood Pressure
Week 8
|
68.06 mm Hg.
Standard Error 2.46
|
68.40 mm Hg.
Standard Error 2.17
|
—
|
|
Diastolic Blood Pressure
Week 10
|
70.81 mm Hg.
Standard Error 2.58
|
67.06 mm Hg.
Standard Error 2.56
|
—
|
|
Diastolic Blood Pressure
Week 12
|
77.11 mm Hg.
Standard Error 2.58
|
70.05 mm Hg.
Standard Error 2.34
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline through week 12.Clinician completed dimensional assessment of anxiety symptoms.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline through week 12.Clinician completed dimensional rating of depressive symptoms.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline through week 12.Dimensional self-report of irritability, with total score 1-12, and higher scores indicating greater severity.
Outcome measures
Outcome data not reported
Adverse Events
Fluoxetine
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Open Lisdexamfetamine
Serious events: 0 serious events
Other events: 30 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Fluoxetine
n=12 participants at risk
All participants initially enrolled in open lisdexamfetamine treatment, followed by randomization to adjunctive fluoxetine at week 4 and continuing though week 12.
|
Placebo
n=14 participants at risk
All participants initially enrolled in open lisdexamfetamine treatment, followed by randomization to adjunctive placebo at study week 4 and continuing through week 12.
|
Open Lisdexamfetamine
n=34 participants at risk
All eligible participants initially titrated to optimal dose open lisdexamfetamine from baseline through week 4.
|
|---|---|---|---|
|
Gastrointestinal disorders
Stomach pain/ache
|
0.00%
0/12 • Baseline through study week 12.
Adverse events were collected via structured ratings, including the Columbia Suicide Severity Rating Scale and the Side Effects Rating Scale.
|
7.1%
1/14 • Number of events 1 • Baseline through study week 12.
Adverse events were collected via structured ratings, including the Columbia Suicide Severity Rating Scale and the Side Effects Rating Scale.
|
11.8%
4/34 • Number of events 5 • Baseline through study week 12.
Adverse events were collected via structured ratings, including the Columbia Suicide Severity Rating Scale and the Side Effects Rating Scale.
|
|
Gastrointestinal disorders
Nausea/vomiting
|
8.3%
1/12 • Number of events 1 • Baseline through study week 12.
Adverse events were collected via structured ratings, including the Columbia Suicide Severity Rating Scale and the Side Effects Rating Scale.
|
7.1%
1/14 • Number of events 1 • Baseline through study week 12.
Adverse events were collected via structured ratings, including the Columbia Suicide Severity Rating Scale and the Side Effects Rating Scale.
|
5.9%
2/34 • Number of events 3 • Baseline through study week 12.
Adverse events were collected via structured ratings, including the Columbia Suicide Severity Rating Scale and the Side Effects Rating Scale.
|
|
Gastrointestinal disorders
Diarrhea
|
16.7%
2/12 • Number of events 2 • Baseline through study week 12.
Adverse events were collected via structured ratings, including the Columbia Suicide Severity Rating Scale and the Side Effects Rating Scale.
|
7.1%
1/14 • Number of events 1 • Baseline through study week 12.
Adverse events were collected via structured ratings, including the Columbia Suicide Severity Rating Scale and the Side Effects Rating Scale.
|
8.8%
3/34 • Number of events 3 • Baseline through study week 12.
Adverse events were collected via structured ratings, including the Columbia Suicide Severity Rating Scale and the Side Effects Rating Scale.
|
|
Psychiatric disorders
Wish to be dead
|
8.3%
1/12 • Number of events 3 • Baseline through study week 12.
Adverse events were collected via structured ratings, including the Columbia Suicide Severity Rating Scale and the Side Effects Rating Scale.
|
14.3%
2/14 • Number of events 2 • Baseline through study week 12.
Adverse events were collected via structured ratings, including the Columbia Suicide Severity Rating Scale and the Side Effects Rating Scale.
|
0.00%
0/34 • Baseline through study week 12.
Adverse events were collected via structured ratings, including the Columbia Suicide Severity Rating Scale and the Side Effects Rating Scale.
|
|
Psychiatric disorders
Suicidal ideation without intent
|
8.3%
1/12 • Number of events 1 • Baseline through study week 12.
Adverse events were collected via structured ratings, including the Columbia Suicide Severity Rating Scale and the Side Effects Rating Scale.
|
0.00%
0/14 • Baseline through study week 12.
Adverse events were collected via structured ratings, including the Columbia Suicide Severity Rating Scale and the Side Effects Rating Scale.
|
0.00%
0/34 • Baseline through study week 12.
Adverse events were collected via structured ratings, including the Columbia Suicide Severity Rating Scale and the Side Effects Rating Scale.
|
|
Nervous system disorders
Headache
|
8.3%
1/12 • Number of events 1 • Baseline through study week 12.
Adverse events were collected via structured ratings, including the Columbia Suicide Severity Rating Scale and the Side Effects Rating Scale.
|
7.1%
1/14 • Number of events 1 • Baseline through study week 12.
Adverse events were collected via structured ratings, including the Columbia Suicide Severity Rating Scale and the Side Effects Rating Scale.
|
14.7%
5/34 • Number of events 8 • Baseline through study week 12.
Adverse events were collected via structured ratings, including the Columbia Suicide Severity Rating Scale and the Side Effects Rating Scale.
|
|
General disorders
Feeling drowsy/sleep
|
8.3%
1/12 • Number of events 2 • Baseline through study week 12.
Adverse events were collected via structured ratings, including the Columbia Suicide Severity Rating Scale and the Side Effects Rating Scale.
|
7.1%
1/14 • Number of events 1 • Baseline through study week 12.
Adverse events were collected via structured ratings, including the Columbia Suicide Severity Rating Scale and the Side Effects Rating Scale.
|
11.8%
4/34 • Number of events 5 • Baseline through study week 12.
Adverse events were collected via structured ratings, including the Columbia Suicide Severity Rating Scale and the Side Effects Rating Scale.
|
|
General disorders
Dry mouth
|
0.00%
0/12 • Baseline through study week 12.
Adverse events were collected via structured ratings, including the Columbia Suicide Severity Rating Scale and the Side Effects Rating Scale.
|
21.4%
3/14 • Number of events 3 • Baseline through study week 12.
Adverse events were collected via structured ratings, including the Columbia Suicide Severity Rating Scale and the Side Effects Rating Scale.
|
11.8%
4/34 • Number of events 6 • Baseline through study week 12.
Adverse events were collected via structured ratings, including the Columbia Suicide Severity Rating Scale and the Side Effects Rating Scale.
|
|
Gastrointestinal disorders
Constipation
|
25.0%
3/12 • Number of events 3 • Baseline through study week 12.
Adverse events were collected via structured ratings, including the Columbia Suicide Severity Rating Scale and the Side Effects Rating Scale.
|
0.00%
0/14 • Baseline through study week 12.
Adverse events were collected via structured ratings, including the Columbia Suicide Severity Rating Scale and the Side Effects Rating Scale.
|
0.00%
0/34 • Baseline through study week 12.
Adverse events were collected via structured ratings, including the Columbia Suicide Severity Rating Scale and the Side Effects Rating Scale.
|
|
Renal and urinary disorders
Frequent urination
|
0.00%
0/12 • Baseline through study week 12.
Adverse events were collected via structured ratings, including the Columbia Suicide Severity Rating Scale and the Side Effects Rating Scale.
|
0.00%
0/14 • Baseline through study week 12.
Adverse events were collected via structured ratings, including the Columbia Suicide Severity Rating Scale and the Side Effects Rating Scale.
|
2.9%
1/34 • Number of events 2 • Baseline through study week 12.
Adverse events were collected via structured ratings, including the Columbia Suicide Severity Rating Scale and the Side Effects Rating Scale.
|
|
General disorders
Restless/uncomfortable urge to move
|
8.3%
1/12 • Number of events 1 • Baseline through study week 12.
Adverse events were collected via structured ratings, including the Columbia Suicide Severity Rating Scale and the Side Effects Rating Scale.
|
14.3%
2/14 • Number of events 4 • Baseline through study week 12.
Adverse events were collected via structured ratings, including the Columbia Suicide Severity Rating Scale and the Side Effects Rating Scale.
|
2.9%
1/34 • Number of events 2 • Baseline through study week 12.
Adverse events were collected via structured ratings, including the Columbia Suicide Severity Rating Scale and the Side Effects Rating Scale.
|
|
Cardiac disorders
Heart skips beats
|
0.00%
0/12 • Baseline through study week 12.
Adverse events were collected via structured ratings, including the Columbia Suicide Severity Rating Scale and the Side Effects Rating Scale.
|
14.3%
2/14 • Number of events 2 • Baseline through study week 12.
Adverse events were collected via structured ratings, including the Columbia Suicide Severity Rating Scale and the Side Effects Rating Scale.
|
0.00%
0/34 • Baseline through study week 12.
Adverse events were collected via structured ratings, including the Columbia Suicide Severity Rating Scale and the Side Effects Rating Scale.
|
|
Cardiac disorders
Racing heart
|
0.00%
0/12 • Baseline through study week 12.
Adverse events were collected via structured ratings, including the Columbia Suicide Severity Rating Scale and the Side Effects Rating Scale.
|
14.3%
2/14 • Number of events 2 • Baseline through study week 12.
Adverse events were collected via structured ratings, including the Columbia Suicide Severity Rating Scale and the Side Effects Rating Scale.
|
5.9%
2/34 • Number of events 2 • Baseline through study week 12.
Adverse events were collected via structured ratings, including the Columbia Suicide Severity Rating Scale and the Side Effects Rating Scale.
|
|
Cardiac disorders
Chest pain
|
8.3%
1/12 • Number of events 1 • Baseline through study week 12.
Adverse events were collected via structured ratings, including the Columbia Suicide Severity Rating Scale and the Side Effects Rating Scale.
|
0.00%
0/14 • Baseline through study week 12.
Adverse events were collected via structured ratings, including the Columbia Suicide Severity Rating Scale and the Side Effects Rating Scale.
|
5.9%
2/34 • Number of events 2 • Baseline through study week 12.
Adverse events were collected via structured ratings, including the Columbia Suicide Severity Rating Scale and the Side Effects Rating Scale.
|
|
Gastrointestinal disorders
Heartburn
|
8.3%
1/12 • Number of events 1 • Baseline through study week 12.
Adverse events were collected via structured ratings, including the Columbia Suicide Severity Rating Scale and the Side Effects Rating Scale.
|
0.00%
0/14 • Baseline through study week 12.
Adverse events were collected via structured ratings, including the Columbia Suicide Severity Rating Scale and the Side Effects Rating Scale.
|
0.00%
0/34 • Baseline through study week 12.
Adverse events were collected via structured ratings, including the Columbia Suicide Severity Rating Scale and the Side Effects Rating Scale.
|
|
Psychiatric disorders
Trouble sleeping
|
8.3%
1/12 • Number of events 1 • Baseline through study week 12.
Adverse events were collected via structured ratings, including the Columbia Suicide Severity Rating Scale and the Side Effects Rating Scale.
|
28.6%
4/14 • Number of events 6 • Baseline through study week 12.
Adverse events were collected via structured ratings, including the Columbia Suicide Severity Rating Scale and the Side Effects Rating Scale.
|
26.5%
9/34 • Number of events 15 • Baseline through study week 12.
Adverse events were collected via structured ratings, including the Columbia Suicide Severity Rating Scale and the Side Effects Rating Scale.
|
|
Psychiatric disorders
Sleeplessness
|
8.3%
1/12 • Number of events 6 • Baseline through study week 12.
Adverse events were collected via structured ratings, including the Columbia Suicide Severity Rating Scale and the Side Effects Rating Scale.
|
14.3%
2/14 • Number of events 4 • Baseline through study week 12.
Adverse events were collected via structured ratings, including the Columbia Suicide Severity Rating Scale and the Side Effects Rating Scale.
|
11.8%
4/34 • Number of events 9 • Baseline through study week 12.
Adverse events were collected via structured ratings, including the Columbia Suicide Severity Rating Scale and the Side Effects Rating Scale.
|
|
Psychiatric disorders
Nightmares
|
0.00%
0/12 • Baseline through study week 12.
Adverse events were collected via structured ratings, including the Columbia Suicide Severity Rating Scale and the Side Effects Rating Scale.
|
14.3%
2/14 • Number of events 3 • Baseline through study week 12.
Adverse events were collected via structured ratings, including the Columbia Suicide Severity Rating Scale and the Side Effects Rating Scale.
|
2.9%
1/34 • Number of events 1 • Baseline through study week 12.
Adverse events were collected via structured ratings, including the Columbia Suicide Severity Rating Scale and the Side Effects Rating Scale.
|
|
Nervous system disorders
Excessive sweating
|
0.00%
0/12 • Baseline through study week 12.
Adverse events were collected via structured ratings, including the Columbia Suicide Severity Rating Scale and the Side Effects Rating Scale.
|
7.1%
1/14 • Number of events 1 • Baseline through study week 12.
Adverse events were collected via structured ratings, including the Columbia Suicide Severity Rating Scale and the Side Effects Rating Scale.
|
8.8%
3/34 • Number of events 3 • Baseline through study week 12.
Adverse events were collected via structured ratings, including the Columbia Suicide Severity Rating Scale and the Side Effects Rating Scale.
|
|
Nervous system disorders
Tremor/shakiness
|
0.00%
0/12 • Baseline through study week 12.
Adverse events were collected via structured ratings, including the Columbia Suicide Severity Rating Scale and the Side Effects Rating Scale.
|
0.00%
0/14 • Baseline through study week 12.
Adverse events were collected via structured ratings, including the Columbia Suicide Severity Rating Scale and the Side Effects Rating Scale.
|
2.9%
1/34 • Number of events 2 • Baseline through study week 12.
Adverse events were collected via structured ratings, including the Columbia Suicide Severity Rating Scale and the Side Effects Rating Scale.
|
|
General disorders
Decreased appetite
|
58.3%
7/12 • Number of events 24 • Baseline through study week 12.
Adverse events were collected via structured ratings, including the Columbia Suicide Severity Rating Scale and the Side Effects Rating Scale.
|
42.9%
6/14 • Number of events 11 • Baseline through study week 12.
Adverse events were collected via structured ratings, including the Columbia Suicide Severity Rating Scale and the Side Effects Rating Scale.
|
61.8%
21/34 • Number of events 51 • Baseline through study week 12.
Adverse events were collected via structured ratings, including the Columbia Suicide Severity Rating Scale and the Side Effects Rating Scale.
|
|
Nervous system disorders
Tics
|
16.7%
2/12 • Number of events 2 • Baseline through study week 12.
Adverse events were collected via structured ratings, including the Columbia Suicide Severity Rating Scale and the Side Effects Rating Scale.
|
21.4%
3/14 • Number of events 3 • Baseline through study week 12.
Adverse events were collected via structured ratings, including the Columbia Suicide Severity Rating Scale and the Side Effects Rating Scale.
|
11.8%
4/34 • Number of events 7 • Baseline through study week 12.
Adverse events were collected via structured ratings, including the Columbia Suicide Severity Rating Scale and the Side Effects Rating Scale.
|
|
Psychiatric disorders
Euphoria
|
8.3%
1/12 • Number of events 1 • Baseline through study week 12.
Adverse events were collected via structured ratings, including the Columbia Suicide Severity Rating Scale and the Side Effects Rating Scale.
|
7.1%
1/14 • Number of events 1 • Baseline through study week 12.
Adverse events were collected via structured ratings, including the Columbia Suicide Severity Rating Scale and the Side Effects Rating Scale.
|
2.9%
1/34 • Number of events 1 • Baseline through study week 12.
Adverse events were collected via structured ratings, including the Columbia Suicide Severity Rating Scale and the Side Effects Rating Scale.
|
|
Psychiatric disorders
Talks less with others
|
8.3%
1/12 • Number of events 1 • Baseline through study week 12.
Adverse events were collected via structured ratings, including the Columbia Suicide Severity Rating Scale and the Side Effects Rating Scale.
|
14.3%
2/14 • Number of events 2 • Baseline through study week 12.
Adverse events were collected via structured ratings, including the Columbia Suicide Severity Rating Scale and the Side Effects Rating Scale.
|
2.9%
1/34 • Number of events 1 • Baseline through study week 12.
Adverse events were collected via structured ratings, including the Columbia Suicide Severity Rating Scale and the Side Effects Rating Scale.
|
|
Nervous system disorders
Bites fingernails
|
25.0%
3/12 • Number of events 5 • Baseline through study week 12.
Adverse events were collected via structured ratings, including the Columbia Suicide Severity Rating Scale and the Side Effects Rating Scale.
|
14.3%
2/14 • Number of events 6 • Baseline through study week 12.
Adverse events were collected via structured ratings, including the Columbia Suicide Severity Rating Scale and the Side Effects Rating Scale.
|
14.7%
5/34 • Number of events 7 • Baseline through study week 12.
Adverse events were collected via structured ratings, including the Columbia Suicide Severity Rating Scale and the Side Effects Rating Scale.
|
|
Psychiatric disorders
Prone to crying
|
0.00%
0/12 • Baseline through study week 12.
Adverse events were collected via structured ratings, including the Columbia Suicide Severity Rating Scale and the Side Effects Rating Scale.
|
21.4%
3/14 • Number of events 3 • Baseline through study week 12.
Adverse events were collected via structured ratings, including the Columbia Suicide Severity Rating Scale and the Side Effects Rating Scale.
|
17.6%
6/34 • Number of events 9 • Baseline through study week 12.
Adverse events were collected via structured ratings, including the Columbia Suicide Severity Rating Scale and the Side Effects Rating Scale.
|
Additional Information
James J. McGough, M.D.
University of California, Los Angeles
Phone: 310-794-7841
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place