Attention Deficit Disorder With HyperactivityPhase 4NCT03446885
Efficacy of Lisdexamfetamine Dimesylate for Promoting Occupational Success in Young Adults With ADHD
A Phase 4 study testing Lisdexamfetamine Dimesylate 40 MG in people with Attention Deficit Disorder With Hyperactivity, run by Gregory Fabiano at 1 site in United States.
Trial summary
There has been little research on the third area of impairment noted in the Diagnostic and Statistical Manual of Mental Disorders - "occupational functioning." Individuals with ADHD experience job-related impairments including a greater likelihood of being unemployed and not enrolled in school and for those that were… Read more about this study
- Who is it for?
- Ages 16 to 25 years
- Conditions the study is for
- Attention Deficit Disorder With Hyperactivity
- What is being tested?
- Lisdexamfetamine Dimesylate 40 MG
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2018to 30 Aug 2019
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- diagnosis of ADHD
- parental permission and/or teen consent/assent as appropriate
- between 16-25 years of age
- IQ greater than or equal to 70
- permit or license to drive
- ability to read and understand English
Who cannot join
- any medical condition that would contraindicate use of stimulant medication
- any prior adverse response to lisdexamfetamine dimesylate or other stimulant medication
- use of concurrent,non-stimulant psychoactive medication
- diagnosis of schizophrenia or presence of thought disorder symptoms
- autism spectrum disorder
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Lisdexamfetamine Dimesylate for Promoting Occupational Success in Young Adults With Attention-deficit/Hyperactivity Disorder
There has been little research on the third area of impairment noted in the Diagnostic and Statistical Manual of Mental Disorders - "occupational functioning." Individuals with ADHD experience job-related impairments including a greater likelihood of being unemployed and not enrolled in school and for those that were employed they were in a lower status occupation, relative to typically-developing comparison peers. The current literature on analogue workplace settings and the effects of lisdexamfetamine dimesylate includes office-based tasks similar to school seat work. Unfortunately, this is inconsistent with the typical work environment most common for individuals with disabilities such as ADHD where food preparation is the most common job following high school. Therefore, medication effects in this type of setting, most common for individuals with ADHD entering the workforce, need to be studied. The investigators propose to study workplace behavior in an analogue work setting in a laboratory "pizza place." Individuals with ADHD will participate in an interview with a supervisor each day, have a list of deliveries that need to be managed, deal with situations that require occupational judgment and appropriate customer service, and drive to make deliveries accurately and on-time. These behaviors can be reliably assessed within the laboratory. Twenty young adults will participate in two "workdays" within a randomized, double-blind, placebo-controlled design wherein participants will be administered placebo and .3 mg/kg lisdexamfetamine dimesylate in a counter-balanced order.
- Being tested
- Lisdexamfetamine Dimesylate 40 MG, Placebo
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lisdexamfetamine Dimesylate 40 MGDrug
Lisdexamfetamine Dimesylate 40 MG administered orally
PlaceboDrug
Placebo capsule administered orally
| Study group | Role | What they receive |
|---|---|---|
| Lab visit 1 | Experimental | 40 mg of Vyvanse administered q.a.m. or Placebo administered in random, counter-balanced fashion. Receives: Drug: Lisdexamfetamine Dimesylate 40 MG; Drug: Placebo |
| Lab visit 2 | Experimental | 40 mg of Vyvanse administered q.a.m. or Placebo administered in random, counter-balanced fashion. Receives: Drug: Lisdexamfetamine Dimesylate 40 MG; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ratings of Job Application Quality
Three independent coders will review each de-identified application. Following the review of the application, coders will complete a rating form that asks them to make an overall evaluation regarding whether the person was an acceptable job candidate for an interview using a scale of 1 ("definitely not") to 5 ("definitely"). Average rating across coders will be used as the dependent measure.
Measured: during interventional study session, 1 day in duration
Ratings of Job Interview Performance
Three coders who are unaware of the study participant identities or group status will view the job interview videotape and completed a form. Raters will provide a rating of their overall impression of the interview behavior ranging from a score of one (Poor) to four (Outstanding). The average score of the coders will be utilized as a dependent measure.
Measured: during interventional study session, 1 day in duration
Objective Observation of Workplace Productivity
The dependent measures from this aspect of the study are the number of items completed correctly out of the total number of assigned items (i.e., 225). Thus, the score reflects the percentage of items correctly completed out of the 225 assigned and scores could range from 0-100.
Measured: during interventional study session, 1 day in duration
Inattentive/Overactive Rating
In addition to ratings of the interview performance, the rater also will complete the five-item inattentive/overactive (I/O) factor of the Iowa Conners rating scale (Atkins, Pelham, \& Licht, 1989; Loney \& Milich, 1982; Pelham, Milich, Murphy, \& Murphy, 1989). The five items are rated on a scale of Not at all (0) to Very Much (3) and the sum of these items represents the score. The dependent measure will be the score averaged across raters. Scores can range from 0-3 on each item, and the average score of the 5 items was used. Higher scores reflect greater inattentive/overactivity-related behaviors.
Measured: during interventional study session, 1 day in duration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2018
- Study start1 Apr 2018
- Primary completion11 Feb 2019
- Study completion30 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Attention Deficit Disorder With HyperactivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- All participants received placebo and 40 mg Vyvanse in a cross-over design. Order of administration was randomly assigned and counter-balanced across participants
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gregory Fabiano
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Gregory Fabiano, State University of New York at Buffalo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03446885
- Sponsor's protocol ID
- IIR-USA-001277
- Status last verified
- Jun 2021
- First submitted
- 31 Aug 2017
- Last updated
- 24 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gordon CT, Fabiano GA, Hulme KF, Sodano SM, Adragna M, Lim R, Stanford S, Janikowski L, Bufalo B, Rodriguez Z, Swiatek D. Efficacy of lisdexamfetamine dimesylate for promoting occupational success in adolescents and young adults with attention-deficit/hyperactivity disorder. Exp Clin Psychopharmacol. 2021 Aug;29(4):308-318. doi: 10.1037/pha0000365. Epub 2020 Apr 16.
PubMed 32297783
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Lisdexamfetamine Dimesylate for Promoting Occupational Success in Young Adults With Attention-deficit/Hyperactivity Disorder
- ClinicalTrials.gov ID
- NCT03446885
- Acronym / sponsor ID
- IIR-USA-001277
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Gregory FabianoUniversity, hospital or other
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 11 Feb 2019 (actual)
- Study completion
- 30 Aug 2019 (actual)
- First posted
- 27 Feb 2018 (actual)
- Results
- Posted 24 Jun 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
There has been little research on the third area of impairment noted in the Diagnostic and Statistical Manual of Mental Disorders - "occupational functioning." Individuals with ADHD experience job-related impairments including a greater likelihood of being unemployed and not enrolled in school and for those that were employed they were in a lower status occupation, relative to typically-developing comparison peers. The current literature on analogue workplace settings and the effects of lisdexamfetamine dimesylate includes office-based tasks similar to school seat work. Unfortunately, this is inconsistent with the typical work environment most common for individuals with disabilities such as ADHD where food preparation is the most common job following high school. Therefore, medication effects in this type of setting, most common for individuals with ADHD entering the workforce, need to be studied. The investigators propose to study workplace behavior in an analogue work setting in a laboratory "pizza place." Individuals with ADHD will participate in an interview with a supervisor each day, have a list of deliveries that need to be managed, deal with situations that require occupational judgment and appropriate customer service, and drive to make deliveries accurately and on-time. These behaviors can be reliably assessed within the laboratory. Twenty young adults will participate in two "workdays" within a randomized, double-blind, placebo-controlled design wherein participants will be administered placebo and .3 mg/kg lisdexamfetamine dimesylate in a counter-balanced order.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- All participants received placebo and 40 mg Vyvanse in a cross-over design. Order of administration was randomly assigned and counter-balanced across participants
| Arm | Type | Receives |
|---|---|---|
| Lab visit 1 | Experimental | Drug: Lisdexamfetamine Dimesylate 40 MG, Drug: Placebo40 mg of Vyvanse administered q.a.m. or Placebo administered in random, counter-balanced fashion. |
| Lab visit 2 | Experimental | Drug: Lisdexamfetamine Dimesylate 40 MG, Drug: Placebo40 mg of Vyvanse administered q.a.m. or Placebo administered in random, counter-balanced fashion. |
Who may qualify
- Ages
- 16 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- diagnosis of ADHD
- parental permission and/or teen consent/assent as appropriate
- between 16-25 years of age
- IQ greater than or equal to 70
- permit or license to drive
Key exclusion criteria (5 listed)
- any medical condition that would contraindicate use of stimulant medication
- any prior adverse response to lisdexamfetamine dimesylate or other stimulant medication
- use of concurrent,non-stimulant psychoactive medication
- diagnosis of schizophrenia or presence of thought disorder symptoms
- autism spectrum disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lisdexamfetamine Dimesylate 40 MGLisdexamfetamine Dimesylate 40 MG administered orally | Drug | Lab visit 1, Lab visit 2 |
| PlaceboPlacebo capsule administered orally | Drug | Lab visit 1, Lab visit 2 |
Primary outcome
Ratings of Job Application Quality
Time frame: during interventional study session, 1 day in duration
Three independent coders will review each de-identified application. Following the review of the application, coders will complete a rating form that asks them to make an overall evaluation regarding whether the person was an acceptable job candidate for an interview using a scale of 1 ("definitely not") to 5 ("definitely"). Average rating across coders will be used as the dependent measure.
Ratings of Job Interview Performance
Time frame: during interventional study session, 1 day in duration
Three coders who are unaware of the study participant identities or group status will view the job interview videotape and completed a form. Raters will provide a rating of their overall impression of the interview behavior ranging from a score of one (Poor) to four (Outstanding). The average score of the coders will be utilized as a dependent measure.
Objective Observation of Workplace Productivity
Time frame: during interventional study session, 1 day in duration
The dependent measures from this aspect of the study are the number of items completed correctly out of the total number of assigned items (i.e., 225). Thus, the score reflects the percentage of items correctly completed out of the 225 assigned and scores could range from 0-100.
Inattentive/Overactive Rating
Time frame: during interventional study session, 1 day in duration
In addition to ratings of the interview performance, the rater also will complete the five-item inattentive/overactive (I/O) factor of the Iowa Conners rating scale (Atkins, Pelham, \& Licht, 1989; Loney \& Milich, 1982; Pelham, Milich, Murphy, \& Murphy, 1989). The five items are rated on a scale of Not at all (0) to Very Much (3) and the sum of these items represents the score. The dependent measure will be the score averaged across raters. Scores can range from 0-3 on each item, and the average score of the 5 items was used. Higher scores reflect greater inattentive/overactivity-related behaviors.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32297783Gordon CT, Fabiano GA, Hulme KF, Sodano SM, Adragna M, Lim R, Stanford S, Janikowski L, Bufalo B, Rodriguez Z, Swiatek D. Efficacy of lisdexamfetamine dimesylate for promoting occupational success in adolescents and young adults with attention-deficit/hyperactivity disorder. Exp Clin Psychopharmacol. 2021 Aug;29(4):308-318. doi: 10.1037/pha0000365. Epub 2020 Apr 16.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lisdexamfetamine Dimesylate 40 MG in people with Attention Deficit Disorder With Hyperactivity, run by Gregory Fabiano at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Jun 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ratings of Job Application Quality (time frame: during interventional study session, 1 day in duration). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03446885, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2021.