Trial Outcomes & Findings for Cognitive-Behavioral and Pharmacologic (LDX) Treatment of Binge-Eating Disorder and Obesity: Acute Treatment (NCT NCT03924193)
NCT ID: NCT03924193
Last Updated: 2024-10-17
Results Overview
Binge eating will be assessed by interview and self-report and the primary outcomes is frequency. Frequency will be defined continuously (analyzed dimensionally).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
141 participants
Primary outcome timeframe
Post-treatment (3 months)
Results posted on
2024-10-17
Participant Flow
Participant milestones
| Measure |
Lisdexamfetamine Dimesylate (LDX)
Lisdexamfetamine Dimesylate: Participants randomly assigned to this arm will receive 12 weeks of LDX medication.
|
Cognitive-Behavioral Therapy
Cognitive-Behavioral Therapy: Participants randomly assigned to this arm will receive 12 weeks of Cognitive-Behavioral Therapy
|
LDX and Cognitive Behavioral Therapy
Combination LDX and Cognitive-Behavioral Therapy: Participants randomly assigned to this arm will receive 12 weeks of LDX and Cognitive-Behavioral Therapy
|
|---|---|---|---|
|
Overall Study
STARTED
|
47
|
47
|
47
|
|
Overall Study
COMPLETED
|
32
|
37
|
35
|
|
Overall Study
NOT COMPLETED
|
15
|
10
|
12
|
Reasons for withdrawal
| Measure |
Lisdexamfetamine Dimesylate (LDX)
Lisdexamfetamine Dimesylate: Participants randomly assigned to this arm will receive 12 weeks of LDX medication.
|
Cognitive-Behavioral Therapy
Cognitive-Behavioral Therapy: Participants randomly assigned to this arm will receive 12 weeks of Cognitive-Behavioral Therapy
|
LDX and Cognitive Behavioral Therapy
Combination LDX and Cognitive-Behavioral Therapy: Participants randomly assigned to this arm will receive 12 weeks of LDX and Cognitive-Behavioral Therapy
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
10
|
0
|
10
|
|
Overall Study
Withdrawal by Subject
|
5
|
10
|
2
|
Baseline Characteristics
Cognitive-Behavioral and Pharmacologic (LDX) Treatment of Binge-Eating Disorder and Obesity: Acute Treatment
Baseline characteristics by cohort
| Measure |
Lisdexamfetamine Dimesylate (LDX)
n=47 Participants
Lisdexamfetamine Dimesylate: Participants randomly assigned to this arm will receive 12 weeks of LDX medication.
|
Cognitive-Behavioral Therapy
n=47 Participants
Cognitive-Behavioral Therapy: Participants randomly assigned to this arm will receive 12 weeks of Cognitive-Behavioral Therapy
|
LDX and Cognitive Behavioral Therapy
n=47 Participants
Combination LDX and Cognitive-Behavioral Therapy: Participants randomly assigned to this arm will receive 12 weeks of LDX and Cognitive-Behavioral Therapy
|
Total
n=141 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
44.85 Years
STANDARD_DEVIATION 11.0 • n=5 Participants
|
41.40 Years
STANDARD_DEVIATION 12.59 • n=7 Participants
|
44.0 Years
STANDARD_DEVIATION 10.80 • n=5 Participants
|
43.55 Years
STANDARD_DEVIATION 11.51 • n=4 Participants
|
|
Sex: Female, Male
Female
|
39 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
118 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
23 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
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
7 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
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
36 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
107 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
47 participants
n=5 Participants
|
47 participants
n=7 Participants
|
47 participants
n=5 Participants
|
141 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Post-treatment (3 months)Population: Any instance with a smaller N than specified in the participant flow table and footnote indicates a missing data point.
Binge eating will be assessed by interview and self-report and the primary outcomes is frequency. Frequency will be defined continuously (analyzed dimensionally).
Outcome measures
| Measure |
Lisdexamfetamine Dimesylate (LDX)
n=42 Participants
Lisdexamfetamine Dimesylate: Participants randomly assigned to this arm will receive 12 weeks of LDX medication.
|
Cognitive-Behavioral Therapy
n=36 Participants
Cognitive-Behavioral Therapy: Participants randomly assigned to this arm will receive 12 weeks of Cognitive-Behavioral Therapy
|
LDX and Cognitive Behavioral Therapy
n=45 Participants
Combination LDX and Cognitive-Behavioral Therapy: Participants randomly assigned to this arm will receive 12 weeks of LDX and Cognitive-Behavioral Therapy
|
|---|---|---|---|
|
Binge-Eating Frequency
|
2.95 Binge-eating episodes (past 28 days)
Standard Deviation 6.04
|
2.33 Binge-eating episodes (past 28 days)
Standard Deviation 5.88
|
0.96 Binge-eating episodes (past 28 days)
Standard Deviation 2.67
|
PRIMARY outcome
Timeframe: Post-treatment (3 months)Population: Any instance with a smaller N than specified in the participant flow table and footnote indicates a missing data point.
BMI is calculated using measured height and weight (e.g., percent loss). We note that % BMI change and % Weight Loss are exactly the same (when height is kept constant, which was the case with this short-term study with adults). Negative values indicate weight loss and positive values indicate weight gain.
Outcome measures
| Measure |
Lisdexamfetamine Dimesylate (LDX)
n=42 Participants
Lisdexamfetamine Dimesylate: Participants randomly assigned to this arm will receive 12 weeks of LDX medication.
|
Cognitive-Behavioral Therapy
n=36 Participants
Cognitive-Behavioral Therapy: Participants randomly assigned to this arm will receive 12 weeks of Cognitive-Behavioral Therapy
|
LDX and Cognitive Behavioral Therapy
n=45 Participants
Combination LDX and Cognitive-Behavioral Therapy: Participants randomly assigned to this arm will receive 12 weeks of LDX and Cognitive-Behavioral Therapy
|
|---|---|---|---|
|
Body Mass Index
|
-5.49 percentage of change in weight
Standard Deviation 3.47
|
-0.50 percentage of change in weight
Standard Deviation 2.70
|
-4.76 percentage of change in weight
Standard Deviation 3.57
|
SECONDARY outcome
Timeframe: Post-treatment (3 months)Categorical: zero binges/28 days
Outcome measures
| Measure |
Lisdexamfetamine Dimesylate (LDX)
n=47 Participants
Lisdexamfetamine Dimesylate: Participants randomly assigned to this arm will receive 12 weeks of LDX medication.
|
Cognitive-Behavioral Therapy
n=47 Participants
Cognitive-Behavioral Therapy: Participants randomly assigned to this arm will receive 12 weeks of Cognitive-Behavioral Therapy
|
LDX and Cognitive Behavioral Therapy
n=47 Participants
Combination LDX and Cognitive-Behavioral Therapy: Participants randomly assigned to this arm will receive 12 weeks of LDX and Cognitive-Behavioral Therapy
|
|---|---|---|---|
|
Binge-Eating Remission
|
19 Participants
|
21 Participants
|
33 Participants
|
SECONDARY outcome
Timeframe: Post-treatment (3 months)Population: Any instance with a smaller N than specified in the participant flow table and footnote indicates a missing data point.
Eating-disorder psychopathology is a continuous variable as assessed by the global score of the Eating Disorder Examination/Eating Disorder Examination-Questionnaire. Scores range from 0-6 (0=no eating-disorder psychopathology; 6=severe eating-disorder psychopathology).
Outcome measures
| Measure |
Lisdexamfetamine Dimesylate (LDX)
n=39 Participants
Lisdexamfetamine Dimesylate: Participants randomly assigned to this arm will receive 12 weeks of LDX medication.
|
Cognitive-Behavioral Therapy
n=35 Participants
Cognitive-Behavioral Therapy: Participants randomly assigned to this arm will receive 12 weeks of Cognitive-Behavioral Therapy
|
LDX and Cognitive Behavioral Therapy
n=44 Participants
Combination LDX and Cognitive-Behavioral Therapy: Participants randomly assigned to this arm will receive 12 weeks of LDX and Cognitive-Behavioral Therapy
|
|---|---|---|---|
|
Eating-Disorder Psychopathology
|
1.62 scores on a scale ranging from 0-6
Standard Deviation 0.94
|
1.89 scores on a scale ranging from 0-6
Standard Deviation 0.97
|
1.07 scores on a scale ranging from 0-6
Standard Deviation 0.68
|
SECONDARY outcome
Timeframe: Post-treatment (3 months)Population: Any instance with a smaller N than specified in the participant flow table and footnote indicates a missing data point.
Depressive symptoms is a continuous variable of depressive symptomatology as assessed by the self-report measure, the Beck Depression Inventory - Second Edition. Scores range from 0-63 (0=no depressive symptoms, 63=greater depressive symptoms).
Outcome measures
| Measure |
Lisdexamfetamine Dimesylate (LDX)
n=37 Participants
Lisdexamfetamine Dimesylate: Participants randomly assigned to this arm will receive 12 weeks of LDX medication.
|
Cognitive-Behavioral Therapy
n=35 Participants
Cognitive-Behavioral Therapy: Participants randomly assigned to this arm will receive 12 weeks of Cognitive-Behavioral Therapy
|
LDX and Cognitive Behavioral Therapy
n=43 Participants
Combination LDX and Cognitive-Behavioral Therapy: Participants randomly assigned to this arm will receive 12 weeks of LDX and Cognitive-Behavioral Therapy
|
|---|---|---|---|
|
Depressive Symptoms
|
8.24 scores on a scale ranging from 0-63
Standard Deviation 7.57
|
10.97 scores on a scale ranging from 0-63
Standard Deviation 10.26
|
7.02 scores on a scale ranging from 0-63
Standard Deviation 7.39
|
Adverse Events
Lisdexamfetamine Dimesylate (LDX)
Serious events: 1 serious events
Other events: 46 other events
Deaths: 0 deaths
Cognitive-Behavioral Therapy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
LDX and Cognitive Behavioral Therapy
Serious events: 0 serious events
Other events: 46 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Lisdexamfetamine Dimesylate (LDX)
n=47 participants at risk
Lisdexamfetamine Dimesylate: Participants randomly assigned to this arm will receive 12 weeks of LDX medication.
|
Cognitive-Behavioral Therapy
n=47 participants at risk
Cognitive-Behavioral Therapy: Participants randomly assigned to this arm will receive 12 weeks of Cognitive-Behavioral Therapy
|
LDX and Cognitive Behavioral Therapy
n=47 participants at risk
Combination LDX and Cognitive-Behavioral Therapy: Participants randomly assigned to this arm will receive 12 weeks of LDX and Cognitive-Behavioral Therapy
|
|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Bruxism
|
2.1%
1/47 • Reported adverse events were only monitored and collected for those receiving pharmacologic treatment for the first month of treatment.
Mortality and serious adverse events were assessed for all intervention groups but adverse events (e.g., side effects expected for the study medication, LDX) were assessed only for the medication groups (LDX and LDX+CBT).
|
0.00%
0/47 • Reported adverse events were only monitored and collected for those receiving pharmacologic treatment for the first month of treatment.
Mortality and serious adverse events were assessed for all intervention groups but adverse events (e.g., side effects expected for the study medication, LDX) were assessed only for the medication groups (LDX and LDX+CBT).
|
0.00%
0/47 • Reported adverse events were only monitored and collected for those receiving pharmacologic treatment for the first month of treatment.
Mortality and serious adverse events were assessed for all intervention groups but adverse events (e.g., side effects expected for the study medication, LDX) were assessed only for the medication groups (LDX and LDX+CBT).
|
Other adverse events
| Measure |
Lisdexamfetamine Dimesylate (LDX)
n=47 participants at risk
Lisdexamfetamine Dimesylate: Participants randomly assigned to this arm will receive 12 weeks of LDX medication.
|
Cognitive-Behavioral Therapy
n=47 participants at risk
Cognitive-Behavioral Therapy: Participants randomly assigned to this arm will receive 12 weeks of Cognitive-Behavioral Therapy
|
LDX and Cognitive Behavioral Therapy
n=47 participants at risk
Combination LDX and Cognitive-Behavioral Therapy: Participants randomly assigned to this arm will receive 12 weeks of LDX and Cognitive-Behavioral Therapy
|
|---|---|---|---|
|
Gastrointestinal disorders
Decreased appetite
|
89.4%
42/47 • Reported adverse events were only monitored and collected for those receiving pharmacologic treatment for the first month of treatment.
Mortality and serious adverse events were assessed for all intervention groups but adverse events (e.g., side effects expected for the study medication, LDX) were assessed only for the medication groups (LDX and LDX+CBT).
|
—
0/0 • Reported adverse events were only monitored and collected for those receiving pharmacologic treatment for the first month of treatment.
Mortality and serious adverse events were assessed for all intervention groups but adverse events (e.g., side effects expected for the study medication, LDX) were assessed only for the medication groups (LDX and LDX+CBT).
|
74.5%
35/47 • Reported adverse events were only monitored and collected for those receiving pharmacologic treatment for the first month of treatment.
Mortality and serious adverse events were assessed for all intervention groups but adverse events (e.g., side effects expected for the study medication, LDX) were assessed only for the medication groups (LDX and LDX+CBT).
|
|
General disorders
Dry Mouth
|
59.6%
28/47 • Reported adverse events were only monitored and collected for those receiving pharmacologic treatment for the first month of treatment.
Mortality and serious adverse events were assessed for all intervention groups but adverse events (e.g., side effects expected for the study medication, LDX) were assessed only for the medication groups (LDX and LDX+CBT).
|
—
0/0 • Reported adverse events were only monitored and collected for those receiving pharmacologic treatment for the first month of treatment.
Mortality and serious adverse events were assessed for all intervention groups but adverse events (e.g., side effects expected for the study medication, LDX) were assessed only for the medication groups (LDX and LDX+CBT).
|
55.3%
26/47 • Reported adverse events were only monitored and collected for those receiving pharmacologic treatment for the first month of treatment.
Mortality and serious adverse events were assessed for all intervention groups but adverse events (e.g., side effects expected for the study medication, LDX) were assessed only for the medication groups (LDX and LDX+CBT).
|
|
General disorders
Increased Energy
|
55.3%
26/47 • Reported adverse events were only monitored and collected for those receiving pharmacologic treatment for the first month of treatment.
Mortality and serious adverse events were assessed for all intervention groups but adverse events (e.g., side effects expected for the study medication, LDX) were assessed only for the medication groups (LDX and LDX+CBT).
|
—
0/0 • Reported adverse events were only monitored and collected for those receiving pharmacologic treatment for the first month of treatment.
Mortality and serious adverse events were assessed for all intervention groups but adverse events (e.g., side effects expected for the study medication, LDX) were assessed only for the medication groups (LDX and LDX+CBT).
|
53.2%
25/47 • Reported adverse events were only monitored and collected for those receiving pharmacologic treatment for the first month of treatment.
Mortality and serious adverse events were assessed for all intervention groups but adverse events (e.g., side effects expected for the study medication, LDX) were assessed only for the medication groups (LDX and LDX+CBT).
|
|
General disorders
Feeling Jittery
|
38.3%
18/47 • Reported adverse events were only monitored and collected for those receiving pharmacologic treatment for the first month of treatment.
Mortality and serious adverse events were assessed for all intervention groups but adverse events (e.g., side effects expected for the study medication, LDX) were assessed only for the medication groups (LDX and LDX+CBT).
|
—
0/0 • Reported adverse events were only monitored and collected for those receiving pharmacologic treatment for the first month of treatment.
Mortality and serious adverse events were assessed for all intervention groups but adverse events (e.g., side effects expected for the study medication, LDX) were assessed only for the medication groups (LDX and LDX+CBT).
|
34.0%
16/47 • Reported adverse events were only monitored and collected for those receiving pharmacologic treatment for the first month of treatment.
Mortality and serious adverse events were assessed for all intervention groups but adverse events (e.g., side effects expected for the study medication, LDX) were assessed only for the medication groups (LDX and LDX+CBT).
|
|
General disorders
Insomnia
|
29.8%
14/47 • Reported adverse events were only monitored and collected for those receiving pharmacologic treatment for the first month of treatment.
Mortality and serious adverse events were assessed for all intervention groups but adverse events (e.g., side effects expected for the study medication, LDX) were assessed only for the medication groups (LDX and LDX+CBT).
|
—
0/0 • Reported adverse events were only monitored and collected for those receiving pharmacologic treatment for the first month of treatment.
Mortality and serious adverse events were assessed for all intervention groups but adverse events (e.g., side effects expected for the study medication, LDX) were assessed only for the medication groups (LDX and LDX+CBT).
|
34.0%
16/47 • Reported adverse events were only monitored and collected for those receiving pharmacologic treatment for the first month of treatment.
Mortality and serious adverse events were assessed for all intervention groups but adverse events (e.g., side effects expected for the study medication, LDX) were assessed only for the medication groups (LDX and LDX+CBT).
|
|
Nervous system disorders
Increased Heart Rate
|
21.3%
10/47 • Reported adverse events were only monitored and collected for those receiving pharmacologic treatment for the first month of treatment.
Mortality and serious adverse events were assessed for all intervention groups but adverse events (e.g., side effects expected for the study medication, LDX) were assessed only for the medication groups (LDX and LDX+CBT).
|
—
0/0 • Reported adverse events were only monitored and collected for those receiving pharmacologic treatment for the first month of treatment.
Mortality and serious adverse events were assessed for all intervention groups but adverse events (e.g., side effects expected for the study medication, LDX) were assessed only for the medication groups (LDX and LDX+CBT).
|
19.1%
9/47 • Reported adverse events were only monitored and collected for those receiving pharmacologic treatment for the first month of treatment.
Mortality and serious adverse events were assessed for all intervention groups but adverse events (e.g., side effects expected for the study medication, LDX) were assessed only for the medication groups (LDX and LDX+CBT).
|
|
Gastrointestinal disorders
Diarrhea
|
12.8%
6/47 • Reported adverse events were only monitored and collected for those receiving pharmacologic treatment for the first month of treatment.
Mortality and serious adverse events were assessed for all intervention groups but adverse events (e.g., side effects expected for the study medication, LDX) were assessed only for the medication groups (LDX and LDX+CBT).
|
—
0/0 • Reported adverse events were only monitored and collected for those receiving pharmacologic treatment for the first month of treatment.
Mortality and serious adverse events were assessed for all intervention groups but adverse events (e.g., side effects expected for the study medication, LDX) were assessed only for the medication groups (LDX and LDX+CBT).
|
12.8%
6/47 • Reported adverse events were only monitored and collected for those receiving pharmacologic treatment for the first month of treatment.
Mortality and serious adverse events were assessed for all intervention groups but adverse events (e.g., side effects expected for the study medication, LDX) were assessed only for the medication groups (LDX and LDX+CBT).
|
|
Gastrointestinal disorders
Constipation
|
10.6%
5/47 • Reported adverse events were only monitored and collected for those receiving pharmacologic treatment for the first month of treatment.
Mortality and serious adverse events were assessed for all intervention groups but adverse events (e.g., side effects expected for the study medication, LDX) were assessed only for the medication groups (LDX and LDX+CBT).
|
—
0/0 • Reported adverse events were only monitored and collected for those receiving pharmacologic treatment for the first month of treatment.
Mortality and serious adverse events were assessed for all intervention groups but adverse events (e.g., side effects expected for the study medication, LDX) were assessed only for the medication groups (LDX and LDX+CBT).
|
8.5%
4/47 • Reported adverse events were only monitored and collected for those receiving pharmacologic treatment for the first month of treatment.
Mortality and serious adverse events were assessed for all intervention groups but adverse events (e.g., side effects expected for the study medication, LDX) were assessed only for the medication groups (LDX and LDX+CBT).
|
|
Psychiatric disorders
Anxiety
|
4.3%
2/47 • Reported adverse events were only monitored and collected for those receiving pharmacologic treatment for the first month of treatment.
Mortality and serious adverse events were assessed for all intervention groups but adverse events (e.g., side effects expected for the study medication, LDX) were assessed only for the medication groups (LDX and LDX+CBT).
|
—
0/0 • Reported adverse events were only monitored and collected for those receiving pharmacologic treatment for the first month of treatment.
Mortality and serious adverse events were assessed for all intervention groups but adverse events (e.g., side effects expected for the study medication, LDX) were assessed only for the medication groups (LDX and LDX+CBT).
|
21.3%
10/47 • Reported adverse events were only monitored and collected for those receiving pharmacologic treatment for the first month of treatment.
Mortality and serious adverse events were assessed for all intervention groups but adverse events (e.g., side effects expected for the study medication, LDX) were assessed only for the medication groups (LDX and LDX+CBT).
|
|
General disorders
Itchy Skin
|
4.3%
2/47 • Reported adverse events were only monitored and collected for those receiving pharmacologic treatment for the first month of treatment.
Mortality and serious adverse events were assessed for all intervention groups but adverse events (e.g., side effects expected for the study medication, LDX) were assessed only for the medication groups (LDX and LDX+CBT).
|
—
0/0 • Reported adverse events were only monitored and collected for those receiving pharmacologic treatment for the first month of treatment.
Mortality and serious adverse events were assessed for all intervention groups but adverse events (e.g., side effects expected for the study medication, LDX) were assessed only for the medication groups (LDX and LDX+CBT).
|
12.8%
6/47 • Reported adverse events were only monitored and collected for those receiving pharmacologic treatment for the first month of treatment.
Mortality and serious adverse events were assessed for all intervention groups but adverse events (e.g., side effects expected for the study medication, LDX) were assessed only for the medication groups (LDX and LDX+CBT).
|
|
Nervous system disorders
Excessive Sweating
|
2.1%
1/47 • Reported adverse events were only monitored and collected for those receiving pharmacologic treatment for the first month of treatment.
Mortality and serious adverse events were assessed for all intervention groups but adverse events (e.g., side effects expected for the study medication, LDX) were assessed only for the medication groups (LDX and LDX+CBT).
|
—
0/0 • Reported adverse events were only monitored and collected for those receiving pharmacologic treatment for the first month of treatment.
Mortality and serious adverse events were assessed for all intervention groups but adverse events (e.g., side effects expected for the study medication, LDX) were assessed only for the medication groups (LDX and LDX+CBT).
|
12.8%
6/47 • Reported adverse events were only monitored and collected for those receiving pharmacologic treatment for the first month of treatment.
Mortality and serious adverse events were assessed for all intervention groups but adverse events (e.g., side effects expected for the study medication, LDX) were assessed only for the medication groups (LDX and LDX+CBT).
|
|
Nervous system disorders
Tingling Sensation
|
2.1%
1/47 • Reported adverse events were only monitored and collected for those receiving pharmacologic treatment for the first month of treatment.
Mortality and serious adverse events were assessed for all intervention groups but adverse events (e.g., side effects expected for the study medication, LDX) were assessed only for the medication groups (LDX and LDX+CBT).
|
—
0/0 • Reported adverse events were only monitored and collected for those receiving pharmacologic treatment for the first month of treatment.
Mortality and serious adverse events were assessed for all intervention groups but adverse events (e.g., side effects expected for the study medication, LDX) were assessed only for the medication groups (LDX and LDX+CBT).
|
8.5%
4/47 • Reported adverse events were only monitored and collected for those receiving pharmacologic treatment for the first month of treatment.
Mortality and serious adverse events were assessed for all intervention groups but adverse events (e.g., side effects expected for the study medication, LDX) were assessed only for the medication groups (LDX and LDX+CBT).
|
|
Psychiatric disorders
Racing Thoughts
|
2.1%
1/47 • Reported adverse events were only monitored and collected for those receiving pharmacologic treatment for the first month of treatment.
Mortality and serious adverse events were assessed for all intervention groups but adverse events (e.g., side effects expected for the study medication, LDX) were assessed only for the medication groups (LDX and LDX+CBT).
|
—
0/0 • Reported adverse events were only monitored and collected for those receiving pharmacologic treatment for the first month of treatment.
Mortality and serious adverse events were assessed for all intervention groups but adverse events (e.g., side effects expected for the study medication, LDX) were assessed only for the medication groups (LDX and LDX+CBT).
|
10.6%
5/47 • Reported adverse events were only monitored and collected for those receiving pharmacologic treatment for the first month of treatment.
Mortality and serious adverse events were assessed for all intervention groups but adverse events (e.g., side effects expected for the study medication, LDX) were assessed only for the medication groups (LDX and LDX+CBT).
|
|
General disorders
Nightmare
|
2.1%
1/47 • Reported adverse events were only monitored and collected for those receiving pharmacologic treatment for the first month of treatment.
Mortality and serious adverse events were assessed for all intervention groups but adverse events (e.g., side effects expected for the study medication, LDX) were assessed only for the medication groups (LDX and LDX+CBT).
|
—
0/0 • Reported adverse events were only monitored and collected for those receiving pharmacologic treatment for the first month of treatment.
Mortality and serious adverse events were assessed for all intervention groups but adverse events (e.g., side effects expected for the study medication, LDX) were assessed only for the medication groups (LDX and LDX+CBT).
|
6.4%
3/47 • Reported adverse events were only monitored and collected for those receiving pharmacologic treatment for the first month of treatment.
Mortality and serious adverse events were assessed for all intervention groups but adverse events (e.g., side effects expected for the study medication, LDX) were assessed only for the medication groups (LDX and LDX+CBT).
|
|
General disorders
Mouth/throat Pain
|
2.1%
1/47 • Reported adverse events were only monitored and collected for those receiving pharmacologic treatment for the first month of treatment.
Mortality and serious adverse events were assessed for all intervention groups but adverse events (e.g., side effects expected for the study medication, LDX) were assessed only for the medication groups (LDX and LDX+CBT).
|
—
0/0 • Reported adverse events were only monitored and collected for those receiving pharmacologic treatment for the first month of treatment.
Mortality and serious adverse events were assessed for all intervention groups but adverse events (e.g., side effects expected for the study medication, LDX) were assessed only for the medication groups (LDX and LDX+CBT).
|
6.4%
3/47 • Reported adverse events were only monitored and collected for those receiving pharmacologic treatment for the first month of treatment.
Mortality and serious adverse events were assessed for all intervention groups but adverse events (e.g., side effects expected for the study medication, LDX) were assessed only for the medication groups (LDX and LDX+CBT).
|
|
Psychiatric disorders
Changes to Thought Patterns
|
2.1%
1/47 • Reported adverse events were only monitored and collected for those receiving pharmacologic treatment for the first month of treatment.
Mortality and serious adverse events were assessed for all intervention groups but adverse events (e.g., side effects expected for the study medication, LDX) were assessed only for the medication groups (LDX and LDX+CBT).
|
—
0/0 • Reported adverse events were only monitored and collected for those receiving pharmacologic treatment for the first month of treatment.
Mortality and serious adverse events were assessed for all intervention groups but adverse events (e.g., side effects expected for the study medication, LDX) were assessed only for the medication groups (LDX and LDX+CBT).
|
6.4%
3/47 • Reported adverse events were only monitored and collected for those receiving pharmacologic treatment for the first month of treatment.
Mortality and serious adverse events were assessed for all intervention groups but adverse events (e.g., side effects expected for the study medication, LDX) were assessed only for the medication groups (LDX and LDX+CBT).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place