Attention Deficit Hyperactivity DisorderPhase 4LEIANCT02170298
Lisdexamfetamine's Effect In ADHD in the Brain and Cognition
A Phase 4 study testing Lisdexamfetamine in people with Attention Deficit Hyperactivity Disorder, run by University of California, Davis at 1 site in United States.
Trial summary
The purpose of this study is to identify the effects of lisdexamfetamine (LDX) on the neural and behavioral subcomponents of self-control, that is cognitive control and reward functioning, in adolescents and young adults with attention-deficit/hyperactivity disorder. Read more about this study
- Who is it for?
- Ages 12 to 30 years
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder
- What is being tested?
- Lisdexamfetamine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2014to Jun 2015
- 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 12 to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- The subject is a male or female adolescent or young adult, between the ages of 12 and 30 (inclusive) at the time of the initial signing of the informed consent/assent
- The subject meets DSM Fifth edition (DSM-5) diagnostic criteria for Attention Deficit-Hyperactivity Disorder, Combined-Type. Diagnostic Interviews and Rating Scales will be used to inform about DSM criteria. Participants with 4 or 5 hyperactive/impulsive symptoms may be included at the investigator's discretion.
- This includes a history of childhood symptoms of ADHD for the adult subjects
- The subject, a caregiver, and the investigator must all agree that the present ADHD symptoms cause impairment in the subject's normal routines, which include academic achievement, occupational functioning, social activities, and/or relationships
- Females of childbearing potential (defined by menarche and not having undergone surgical sterilization/hysterectomy) must have a negative pregnancy test, must be practicing acceptable methods of contraception (or can confirm abstinence at each scheduled visit), and must not be pregnant or lactating at any point while they are participating in the study.
- Written informed consent must be obtained from a legally acceptable representative (e.g. guardian or caregiver for minors), in accordance with requirements of the Institutional Review Board (IRB), prior to the initiation of any protocol-required procedures. In addition, the subject, as required by the IRB, must provide informed assent at screening and as such must be able to understand that he or she can withdraw from the time at any time.
- The subject and the designated guardian(s) or caregiver(s)[If minors] are able to comprehend and satisfactorily comply with the protocol requirements, as evaluated by the investigator
Who cannot join
- Clinical contraindications
- History of schizophrenia, bipolar disorder, autism spectrum disorder, specific or focal neurological disorder
- Current academic learning disorder(s)
- Abnormal cardiac functioning with be excluded
- The subject experiences Adverse Events during the trial that would, in the investigator's judgment, preclude further exposure to LDX
- The subject had protocol violations during the trial considered major in the judgment of the investigator (significant noncompliance, use of prohibited concomitant medications, concern with use of drugs of abuse, etc.), which would deem them poor candidates for this trial
Show all 25Show fewer
- Sexually active males who will not commit to utilizing an approved birth control methods or who will not remain abstinent during the trial and for 90 days following the last dose of study drug. Sexually active females of childbearing potential who will not commit to utilizing 1 of the approved birth control methods or who will not remain abstinent during the trial and for 30 days following the last dose of study drug. Abstinence will be permitted if it is confirmed and documented at every trial visit. If employing birth control, 1 of the following precautions must be used: vasectomy, tubal ligation, vaginal diaphragm, intrauterine device, birth control pill, birth control depot injections, implant, condom or sponge with spermicide.
- Subjects with an inability to swallow tablets or tolerate oral medication
- It is in the investigator's opinion that it is not in the subject's best interest to continue
- Contraindication for MRI scanning (e.g., metal implants, pacemakers, metal foreign bodies, pregnancy)
- Beast-feeding (if applicable)
- 1. Females who are breast-feeding and/or who have a positive pregnancy test result prior to receiving trial drug
- Excluded medications
- Agents that lower blood levels of amphetamines: urinary acidifying agents (e.g. ammonium chloride, sodium acid phosphate, etc.); Methenamine Therapy.
- Agents that increase blood levels of amphetamines: urinary alkalinizing agents (e.g. Acetazolamide, some Thiazides).
- Dextroamphetamine is known to inhibit monoamine oxidase, as well as a metabolite of furazolidone. Concurrent administration of monoamine oxidase (MAOI) inhibitors is contraindicated because MAOIs potentially can result in hypertensive crisis. Vyvanse should not be given for at least 14 days after discontinuation of an MAO inhibitor.
- Agents whose effects may be reduced by amphetamines: Adrenergic blockers, Antihistamines, Antihypertensives, Veratrum Alkaloids, Ethosuximide.
- Agents whose effects may be potentiated by amphetamines: Tricyclic antidepressants, meperidine, Norepinephrine, Phenobarbital, Phenytoin.
- Agents that may reduce the effects of amphetamines: Antipsychotics, Lithium Carbonate
- Known allergy/sensitivity or any hypersensitivity to components of study drug(s) or their formulation
- 1. Previous negative history with LDX
- Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements
- A positive drug screen for cocaine or other drugs of abuse (excluding caffeine, nicotine or prescribed psychostimulants for ADD/ADHD)
- History of substance dependence or abuse disorder currently or within past 5 years.
- Recent serious illness requiring systemic treatment and/or hospitalization prior to entry.
Trial locations and contacts
1 site in 1 country.
United States1 site
UC Davis MIND Institute
Sacramento, California, 95817
About this study
Official title: Effects of Lisdexamfetamine on Cognitive Control and Reward Response in Adolescents and Young Adults With ADHD: Neural and Clinical Outcomes
The purpose of this study is to identify the effects of lisdexamfetamine (LDX) on the neural and behavioral subcomponents of self-control, that is cognitive control and reward functioning, in adolescents and young adults with attention-deficit/hyperactivity disorder.
The investigators hypothesize that LDX is associated with 1a) decreased task-independent locus coeruleus (LC) activity; 1b) increased task-related activity in LC and the cognitive control network; 2) increased LC connectivity with the cognitive control network and 3) improved task performance and self-control. The investigators will test their hypotheses on fMRI data with linear contrasts of voxel-wise maps of parameter estimates (in both univariate and connectivity analyses).
Read more
The investigators will also assess change in brain activity with the LDX in the LC and ventral tegmental areas (VTA) as we hypothesize that they are altered in ADHD and related to cognitive control and self-control dysfunction in ADHD.
The investigators will use a repeated-measures, between-subject design to compare the effects of oral once daily LDX in a double-blind placebo-controlled randomized trial (RCT) on neural (fMRI) and behavioral correlates of cognitive control via a working memory and a reward - delay discounting task in adolescents and young adults.
A new condition has been added which will use a within-subject comparison, cross-over design between a single dose of LDX versus a single dose of placebo.
- Conditions
- Attention Deficit Hyperactivity Disorder
- Being tested
- Lisdexamfetamine
- Keywords
- ADHD, Attention Deficit Hyperactivity Disorder, Vyvanse, Lisdexamfetamine
- 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.
LisdexamfetamineDrug
Also called Vyvanse
Participants will be given either the study drug or placebo in tablet form. All participants will start with a 20 mg dose and will be titrated up to a 70 mg daily dose over 9 weeks. Participants between 12-18 years of age will be titrated in 10 mg increments and participants between 18-25 years of age in 10-20 mg increments.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Participants may be randomized into the placebo comparator arm. Participants in this group will be given a sugar pill titrated up to 70 mg daily over the course of 9 weeks.
Drug: Placebo Receives: Drug: Lisdexamfetamine |
| Lisdexamfetamine | Experimental | Participants may be randomized into the experimental arm. Participants in this arm will be given lisdexamfetamine titrated up to 70 mg daily over the course of 9 weeks.
Drug: Lisdexamfetamine Receives: Drug: Lisdexamfetamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Working Memory
Working memory performance, as measured by the percent of items correct on the Span Working Memory Task.
Measured: Baseline, 9 weeks
Delay Discounting
Level of self-control, as demonstrated on the Delay Discounting Task.
Measured: Baseline, 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2014 (estimated)
- Study startFeb 2014
- Primary completionJun 2015
- Study completionJun 2015
Why it stopped: Lack of enrollment
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.
- Other trials for Attention Deficit Hyperactivity DisorderStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Collaborators
- Shire
- Responsible party
- Sponsor
- Investigators
- Julie B Schweitzer, PhD, Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02170298
- Sponsor's protocol ID
- 402395
- Acronym
- LEIA
- Status last verified
- Dec 2019
- First submitted
- 11 Jun 2014
- Last updated
- 26 Dec 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Lisdexamfetamine on Cognitive Control and Reward Response in Adolescents and Young Adults With ADHD: Neural and Clinical Outcomes
- ClinicalTrials.gov ID
- NCT02170298
- Acronym / sponsor ID
- LEIA / 402395
- Conditions
- Attention Deficit Hyperactivity Disorder
- Keywords
- ADHD, Attention Deficit Hyperactivity Disorder, Vyvanse, Lisdexamfetamine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of enrollment
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Collaborators
- Shire
- Study start
- Feb 2014 (actual)
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 23 Jun 2014 (estimated)
- Results
- Posted 26 Dec 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to identify the effects of lisdexamfetamine (LDX) on the neural and behavioral subcomponents of self-control, that is cognitive control and reward functioning, in adolescents and young adults with attention-deficit/hyperactivity disorder.
The investigators hypothesize that LDX is associated with 1a) decreased task-independent locus coeruleus (LC) activity; 1b) increased task-related activity in LC and the cognitive control network; 2) increased LC connectivity with the cognitive control network and 3) improved task performance and self-control. The investigators will test their hypotheses on fMRI data with linear contrasts of voxel-wise maps of parameter estimates (in both univariate and connectivity analyses).
The investigators will also assess change in brain activity with the LDX in the LC and ventral tegmental areas (VTA) as we hypothesize that they are altered in ADHD and related to cognitive control and self-control dysfunction in ADHD.
The investigators will use a repeated-measures, between-subject design to compare the effects of oral once daily LDX in a double-blind placebo-controlled randomized trial (RCT) on neural (fMRI) and behavioral correlates of cognitive control via a working memory and a reward - delay discounting task in adolescents and young adults.
A new condition has been added which will use a within-subject comparison, cross-over design between a single dose of LDX versus a single dose of placebo.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: LisdexamfetamineParticipants may be randomized into the placebo comparator arm. Participants in this group will be given a sugar pill titrated up to 70 mg daily over the course of 9 weeks. Drug: Placebo |
| Lisdexamfetamine | Experimental | Drug: LisdexamfetamineParticipants may be randomized into the experimental arm. Participants in this arm will be given lisdexamfetamine titrated up to 70 mg daily over the course of 9 weeks. Drug: Lisdexamfetamine |
Who may qualify
- Ages
- 12 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- The subject is a male or female adolescent or young adult, between the ages of 12 and 30 (inclusive) at the time of the initial signing of the informed consent/assent
- The subject meets DSM Fifth edition (DSM-5) diagnostic criteria for Attention Deficit-Hyperactivity Disorder, Combined-Type. Diagnostic Interviews and Rating Scales will be used to inform about DSM criteria. Participants with 4 or 5 hyperactive/impulsive symptoms may be included at the investigator's discretion.
- This includes a history of childhood symptoms of ADHD for the adult subjects
- The subject, a caregiver, and the investigator must all agree that the present ADHD symptoms cause impairment in the subject's normal routines, which include academic achievement, occupational functioning, social activities, and/or relationships
- Females of childbearing potential (defined by menarche and not having undergone surgical sterilization/hysterectomy) must have a negative pregnancy test, must be practicing acceptable methods of contraception (or can confirm abstinence at each scheduled visit), and must not be pregnant or lactating at any point while they are participating in the study.
Key exclusion criteria (25 listed)
- Clinical contraindications
- Beast-feeding (if applicable)
- 1. Females who are breast-feeding and/or who have a positive pregnancy test result prior to receiving trial drug
- Excluded medications
- Known allergy/sensitivity or any hypersensitivity to components of study drug(s) or their formulation
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 |
|---|---|---|
| LisdexamfetamineAlso: VyvanseParticipants will be given either the study drug or placebo in tablet form. All participants will start with a 20 mg dose and will be titrated up to a 70 mg daily dose over 9 weeks. Participants between 12-18 years of age will be titrated in 10 mg increments and participants between 18-25 years of age in 10-20 mg increments. | Drug | Lisdexamfetamine, Placebo |
Primary outcome
Working Memory
Time frame: Baseline, 9 weeks
Working memory performance, as measured by the percent of items correct on the Span Working Memory Task.
Delay Discounting
Time frame: Baseline, 9 weeks
Level of self-control, as demonstrated on the Delay Discounting Task.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Attention Deficit Hyperactivity Disorder
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Conduct Disorder
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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.
Julie B Schweitzer, PhD principal investigator
University of California, Davis
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 in people with Attention Deficit Hyperactivity Disorder, run by University of California, Davis 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 7 inclusion and 25 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: stopped early, as of the sponsor's last update on 26 Dec 2019. 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. Some participants in this study may receive a placebo. 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 26 Dec 2019). 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?
Working Memory (time frame: Baseline, 9 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Dec 2019.