Trial Outcomes & Findings for Pharmacological and Behavioral Treatment After Bariatric Surgery: Medication Change for Non-Responders (Stage 2b) (NCT NCT04599504)
NCT ID: NCT04599504
Last Updated: 2026-08-06
Results Overview
Loss-of-control eating frequency is a continuous variable of loss-of-control eating episodes assessed using the Eating Disorder Examination interview; Loss-of-control eating frequency will be based on the past 28 days and defined as loss-of-control eating episodes per month.
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
16 participants
Primary outcome timeframe
At the end of 12-week treatment
Results posted on
2026-08-06
Participant Flow
Participant milestones
| Measure |
Placebo
Participants randomized to this arm received an inactive placebo pill (taken daily) for 12 weeks.
|
Lisdexamfetamine Dimesylate
Participants randomized to this arm received Lisdexamfetamine dimesylate (one pill daily) for 12 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
7
|
9
|
|
Overall Study
COMPLETED
|
4
|
9
|
|
Overall Study
NOT COMPLETED
|
3
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pharmacological and Behavioral Treatment After Bariatric Surgery: Medication Change for Non-Responders (Stage 2b)
Baseline characteristics by cohort
| Measure |
Lisdexamfetamine Dimesylate
n=9 Participants
Participants randomized to this arm received Lisdexamfetamine dimesylate (one pill daily) for 12 weeks.
|
Placebo
n=7 Participants
Participants randomized to this arm received an inactive placebo pill (taken daily) for 12 weeks.
|
Total
n=16 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Age, Continuous
|
50.89 years
STANDARD_DEVIATION 9.33 • n=20 Participants
|
49.29 years
STANDARD_DEVIATION 9.45 • n=20 Participants
|
50.19 years
STANDARD_DEVIATION 9.10 • n=40 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=20 Participants
|
7 Participants
n=20 Participants
|
14 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
2 Participants
n=40 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
2 Participants
n=40 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=20 Participants
|
6 Participants
n=20 Participants
|
13 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
2 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=20 Participants
|
6 Participants
n=20 Participants
|
14 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
PRIMARY outcome
Timeframe: At the end of 12-week treatmentLoss-of-control eating frequency is a continuous variable of loss-of-control eating episodes assessed using the Eating Disorder Examination interview; Loss-of-control eating frequency will be based on the past 28 days and defined as loss-of-control eating episodes per month.
Outcome measures
| Measure |
Placebo
n=4 Participants
Participants randomized to this arm received an inactive placebo pill (taken daily) for 12 weeks.
|
Lisdexamfetamine Dimesylate
n=9 Participants
Participants randomized to this arm received Lisdexamfetamine dimesylate (one pill daily) for 12 weeks.
|
|---|---|---|
|
Loss-of-Control Eating Frequency
|
11.25 episodes per the past 28 days
Standard Deviation 10.31
|
6.11 episodes per the past 28 days
Standard Deviation 6.72
|
PRIMARY outcome
Timeframe: 6-month follow-up from the end of treatmentLoss-of-control eating frequency is a continuous variable of loss-of-control eating episodes assessed using the Eating Disorder Examination interview; Loss-of-control eating frequency will be based on the past 28 days and defined as loss-of-control eating episodes per month.
Outcome measures
| Measure |
Placebo
n=3 Participants
Participants randomized to this arm received an inactive placebo pill (taken daily) for 12 weeks.
|
Lisdexamfetamine Dimesylate
n=4 Participants
Participants randomized to this arm received Lisdexamfetamine dimesylate (one pill daily) for 12 weeks.
|
|---|---|---|
|
Loss-of-Control Eating Frequency
|
10.00 episodes per the past 28 days
Standard Deviation 6.00
|
10.50 episodes per the past 28 days
Standard Deviation 4.80
|
PRIMARY outcome
Timeframe: 12-month follow-up from the end of treatmentLoss-of-control eating frequency is a continuous variable of loss-of-control eating episodes assessed using the Eating Disorder Examination interview; Loss-of-control eating frequency will be based on the past 28 days and defined as loss-of-control eating episodes per month.
Outcome measures
| Measure |
Placebo
n=3 Participants
Participants randomized to this arm received an inactive placebo pill (taken daily) for 12 weeks.
|
Lisdexamfetamine Dimesylate
n=3 Participants
Participants randomized to this arm received Lisdexamfetamine dimesylate (one pill daily) for 12 weeks.
|
|---|---|---|
|
Loss-of-Control Eating Frequency
|
1.67 episodes per the past 28 days
Standard Deviation 2.08
|
7.67 episodes per the past 28 days
Standard Deviation 3.79
|
PRIMARY outcome
Timeframe: From baseline at study enrollment to after the 12-week treatmentPercent weight loss is calculated based on change from pre-treatment to post-treatment at 3 months. Negative values indicate weight loss.
Outcome measures
| Measure |
Placebo
n=3 Participants
Participants randomized to this arm received an inactive placebo pill (taken daily) for 12 weeks.
|
Lisdexamfetamine Dimesylate
n=9 Participants
Participants randomized to this arm received Lisdexamfetamine dimesylate (one pill daily) for 12 weeks.
|
|---|---|---|
|
Percent Weight Change
|
4.37 percent change
Standard Deviation 1.97
|
-3.80 percent change
Standard Deviation 3.72
|
PRIMARY outcome
Timeframe: From post-treatment to the 6-month follow-upPercent weight loss is calculated based on change from post-treatment to the 6-month follow-up. Negative values indicate weight loss.
Outcome measures
| Measure |
Placebo
n=3 Participants
Participants randomized to this arm received an inactive placebo pill (taken daily) for 12 weeks.
|
Lisdexamfetamine Dimesylate
n=4 Participants
Participants randomized to this arm received Lisdexamfetamine dimesylate (one pill daily) for 12 weeks.
|
|---|---|---|
|
Percent Weight Change
|
6.36 percent change
Standard Deviation 4.00
|
-1.13 percent change
Standard Deviation 7.63
|
PRIMARY outcome
Timeframe: From post-treatment to the 12-month follow-upPercent weight loss is calculated based on change from post-treatment to the 12-month follow-up. Negative values indicate weight loss.
Outcome measures
| Measure |
Placebo
n=3 Participants
Participants randomized to this arm received an inactive placebo pill (taken daily) for 12 weeks.
|
Lisdexamfetamine Dimesylate
n=3 Participants
Participants randomized to this arm received Lisdexamfetamine dimesylate (one pill daily) for 12 weeks.
|
|---|---|---|
|
Percent Weight Change
|
9.07 percent change
Standard Deviation 2.75
|
3.91 percent change
Standard Deviation 7.35
|
Adverse Events
Lisdexamfetamine Dimesylate
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Lisdexamfetamine Dimesylate
n=9 participants at risk
Participants randomized to this arm received Lisdexamfetamine dimesylate (one pill daily) for 12 weeks.
|
Placebo
n=7 participants at risk
Participants randomized to this arm received an inactive placebo pill (taken daily) for 12 weeks.
|
|---|---|---|
|
General disorders
Feeling Jittery
|
22.2%
2/9 • From enrollment to the end of the 12 week treatment
|
14.3%
1/7 • From enrollment to the end of the 12 week treatment
|
|
General disorders
Mouth/Throat Pain
|
11.1%
1/9 • From enrollment to the end of the 12 week treatment
|
0.00%
0/7 • From enrollment to the end of the 12 week treatment
|
|
General disorders
Nightmare
|
0.00%
0/9 • From enrollment to the end of the 12 week treatment
|
14.3%
1/7 • From enrollment to the end of the 12 week treatment
|
|
Psychiatric disorders
Racing Thoughts
|
22.2%
2/9 • From enrollment to the end of the 12 week treatment
|
0.00%
0/7 • From enrollment to the end of the 12 week treatment
|
|
General disorders
Restlessness
|
33.3%
3/9 • From enrollment to the end of the 12 week treatment
|
28.6%
2/7 • From enrollment to the end of the 12 week treatment
|
|
Gastrointestinal disorders
Upper Abdominal Pain
|
0.00%
0/9 • From enrollment to the end of the 12 week treatment
|
14.3%
1/7 • From enrollment to the end of the 12 week treatment
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/9 • From enrollment to the end of the 12 week treatment
|
14.3%
1/7 • From enrollment to the end of the 12 week treatment
|
|
Gastrointestinal disorders
Diarrhea
|
22.2%
2/9 • From enrollment to the end of the 12 week treatment
|
0.00%
0/7 • From enrollment to the end of the 12 week treatment
|
|
General disorders
Dry Mouth
|
77.8%
7/9 • From enrollment to the end of the 12 week treatment
|
14.3%
1/7 • From enrollment to the end of the 12 week treatment
|
|
General disorders
Increased Energy
|
55.6%
5/9 • From enrollment to the end of the 12 week treatment
|
14.3%
1/7 • From enrollment to the end of the 12 week treatment
|
|
Nervous system disorders
Increased Heart Rate
|
11.1%
1/9 • From enrollment to the end of the 12 week treatment
|
14.3%
1/7 • From enrollment to the end of the 12 week treatment
|
|
General disorders
Insomnia
|
33.3%
3/9 • From enrollment to the end of the 12 week treatment
|
14.3%
1/7 • From enrollment to the end of the 12 week treatment
|
|
General disorders
Itchy Skin
|
11.1%
1/9 • From enrollment to the end of the 12 week treatment
|
14.3%
1/7 • From enrollment to the end of the 12 week treatment
|
|
Psychiatric disorders
Anxiety
|
33.3%
3/9 • From enrollment to the end of the 12 week treatment
|
14.3%
1/7 • From enrollment to the end of the 12 week treatment
|
|
Gastrointestinal disorders
Constipation
|
22.2%
2/9 • From enrollment to the end of the 12 week treatment
|
0.00%
0/7 • From enrollment to the end of the 12 week treatment
|
|
Gastrointestinal disorders
Decreased Appetite
|
77.8%
7/9 • From enrollment to the end of the 12 week treatment
|
0.00%
0/7 • From enrollment to the end of the 12 week treatment
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place