Trial · NCT03397446
Lisdexamfetamine for Adults With Bulimia Nervosa
NCT03397446, Phase 2, Terminated, Aaron Keshen
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Lisdexamfetamine for Adults With Bulimia Nervosa. Trials, record NCT03397446. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03397446
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Lisdexamfetamine for Adults With Bulimia Nervosa
- NCT number
- NCT03397446
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 23 participants, actual
- Lead sponsor
- Aaron Keshen
- Conditions
- Bulimia Nervosa
- Interventions
- Lisdexamfetamine dimesylate
- First posted
- 2018-01-12
- Last updated
- 2020-11-27
Source ClinicalTrials.gov
Registered outcomes27
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Enrolment rate | 2 years | Enrolment rate will be defined as the total number of participants enrolled divided by the total enrolment period in months. |
| Primary | Dropout rates | 2 years | Dropout rate will be defined as the number of patients whose participation was terminated prior to completion of the post-treatment assessment divided by the total number of participants enrolled. |
| Primary | The applicability of eligibility criteria | 2 years | The applicability of eligibility criteria will be determined by the ratio of participants screened to participants enrolled. |
| Secondary | Incidence of serious or other treatment-emergent adverse events (TEAEs) | Up to 9 weeks | Subjects will be asked to report TEAEs to the research team and PI. |
| Secondary | Change from baseline in weight/body mass index | Up to 9 weeks | Subjects will be weighed using a calibrated hospital scale while wearing a hospital gown and no footwear. |
| Secondary | Change from baseline in systolic/diastolic blood pressure (mmHg) | Up to 9 weeks | Systolic and diastolic blood pressure will be collected by a study investigator at weekly/biweekly visits. |
| Secondary | Change from baseline in heart rate (bpm) | Up to 9 weeks | Heart rate will be collected by a study investigator at weekly/biweekly visits. |
| Secondary | Incidence of abnormal adherence rates | 2 months | Adherence will be calculated as the number of pills not returned divided by the number of days since the last visit, multiplied by 100 to yield a percentage. Subjects with an adherence rate between 80% and 120% will be considered adherent to treatment. |
| Secondary | Incidence of abnormalities in blood analysis | Up to 9 weeks | Most relevant concerns for patients with BN taking LDX include electrolyte abnormalities (potassium, sodium, chloride) and hypoglycemia |
| Secondary | Incidence of abnormalities in EKG | Up to 9 weeks | Most relevant concerns for patients with BN taking LDX include prolonged QTc, hypertension, and tachycardia. |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests1
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as |
|---|---|
| Two-Step Task | Secondary outcome |
Source ConductCognition
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03397446
GET https://conductscience.org/api/trials/v1/NCT03397446/registered?page=2