Trial · NCT02635035
Shire SCT: Lisdexamfetamine Treatment for ADHD and SCT
NCT02635035, Phase 2, Completed, NYU Langone Health; results first posted 2021-11-16
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Shire SCT: Lisdexamfetamine Treatment for ADHD and SCT. Trials, record NCT02635035. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02635035
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Shire SCT: Lisdexamfetamine Treatment for ADHD and SCT
- NCT number
- NCT02635035
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 38 participants, actual
- Lead sponsor
- NYU Langone Health
- Conditions
- Attention Deficit Disorder, Attention Deficit Hyperactivity Disorder
- Interventions
- Lisdexamfetamine, Placebo
- First posted
- 2015-12-18
- Last updated
- 2021-11-16
- Results first posted
- 2021-11-16
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Score on Barkley Adult ADHD Rating Scale-IV (BAARS-IV) | Baseline, 10 Weeks | The BAARS-IV Self-Report consists of 27 symptoms that can be rated from 1 (never or rarely) to 4 (very often). The total range of scores is 1-108; a higher score indicates ADHD symptoms at a higher frequency. |
| Secondary | Change in Score on Barkley Functional Impairment Scale (BFIS) | Baseline, 10 weeks | BFIS is designed to evaluate possible impairment in 15 major domains of psychosocial functioning in adults. The scale for each domain is 0 to 9 where 0 represents no impairment and 9 represents highest impairment. The total range is 0-135; the higher the score, the higher the impairment. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Score on Barkley Adult ADHD Rating Scale-IV (BAARS-IV) | Baseline, 10 Weeks | The intent of the study was to evaluate the two different sequences (that is, to compare the order of Lisdexamfetamine treatment) rather than to compare Lisdexamfetamine to Placebo. Therefore, data was not collected and reported for Placebo. | score on a scale | MEAN |
| SECONDARY | Change in Score on Barkley Functional Impairment Scale (BFIS) | Baseline, 10 weeks | The intent of the study was to evaluate the two different sequences (that is, to compare the order of Lisdexamfetamine treatment) rather than to compare Lisdexamfetamine to Placebo. Therefore, data was not collected and reported for Placebo. | units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Score on Barkley Adult ADHD Rating Scale-IV (BAARS-IV) | Lisdexamfetamine First | 23.27 | Standard Deviation 7.73 | score on a scale | |
| Change in Score on Barkley Adult ADHD Rating Scale-IV (BAARS-IV) | Lisdexamfetamine Second | 23.1 | Standard Deviation 7.4 | score on a scale | |
| Change in Score on Barkley Functional Impairment Scale (BFIS) | Lisdexamfetamine First | 4.93 | Standard Deviation 2 | units on a scale | |
| Change in Score on Barkley Functional Impairment Scale (BFIS) | Lisdexamfetamine Second | 4.88 | Standard Deviation 2.06 | units on a scale |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Lisdexamfetamine First | 17 | |
| Overall Study | STARTED | Lisdexamfetamine Second | 21 | |
| Overall Study | COMPLETED | Lisdexamfetamine First | 17 | |
| Overall Study | COMPLETED | Lisdexamfetamine Second | 21 | |
| Overall Study | NOT COMPLETED | Lisdexamfetamine First | 0 | |
| Overall Study | NOT COMPLETED | Lisdexamfetamine Second | 0 |
Source ClinicalTrials.gov
Adverse events110
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Nausea | Gastrointestinal disorders | Lisdexamfetamine First | 2 | 17 | 2 |
| other | Nausea | Gastrointestinal disorders | Lisdexamfetamine Second | 0 | 21 | 0 |
| other | Headache | General disorders | Lisdexamfetamine First | 8 | 17 | 13 |
| other | Headache | General disorders | Lisdexamfetamine Second | 5 | 21 | 8 |
| other | Increased Heart Rate | Cardiac disorders | Lisdexamfetamine First | 0 | 17 | 0 |
| other | Increased Heart Rate | Cardiac disorders | Lisdexamfetamine Second | 1 | 21 | 2 |
| other | Irritability | General disorders | Lisdexamfetamine First | 0 | 17 | 0 |
| other | Irritability | General disorders | Lisdexamfetamine Second | 1 | 21 | 1 |
| other | Drowsiness | General disorders | Lisdexamfetamine First | 0 | 17 | 0 |
| other | Drowsiness | General disorders | Lisdexamfetamine Second | 1 | 21 | 2 |
1 to 10 of 110Source ClinicalTrials.gov
See all 110 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Lisdexamfetamine First | 0 | 17 |
| Total, all-cause mortality | Lisdexamfetamine Second | 0 | 21 |
| Total, other adverse events | Lisdexamfetamine First | 16 | 17 |
| Total, other adverse events | Lisdexamfetamine Second | 17 | 21 |
| Total, serious adverse events | Lisdexamfetamine First | 0 | 17 |
| Total, serious adverse events | Lisdexamfetamine Second | 0 | 21 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 34232582 | DERIVED |
Source PubMed
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Lisdexamfetamine First vs Lisdexamfetamine Second: deaths from any cause | Trial comparisons |
| Lisdexamfetamine First vs Lisdexamfetamine Second: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
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/NCT02635035
GET https://conductscience.org/api/trials/v1/NCT02635035/events?page=2