Trial record 24 of 127 for:    ADHD | Open Studies | United States | Child, Adult

Lisdexamfetamine's Effect In ADHD in the Brain and Cognition (LEIA)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by University of California, Davis
Sponsor:
Collaborator:
Shire
Information provided by (Responsible Party):
Julie Schweitzer, University of California, Davis
ClinicalTrials.gov Identifier:
NCT02170298
First received: June 11, 2014
Last updated: June 17, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention Phase
Attention Deficit Hyperactivity Disorder
Drug: Lisdexamfetamine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Effects of Lisdexamfetamine on Cognitive Control and Reward Response in Adolescents and Young Adults With ADHD: Neural and Clinical Outcomes

Resource links provided by NLM:


Further study details as provided by University of California, Davis:

Primary Outcome Measures:
  • Primary Neural Endpoints [ Time Frame: The effects of the medication versus placebo will be assessed after 8 weeks of treatment (or placebo) ] [ Designated as safety issue: No ]
    To evaluate the effects of Lisdexamfetamine on a) task-related regional brain activity (i.e., working memory versus self-control associated brain regions).

  • Primary Cognitive Outcome [ Time Frame: Compare baseline to 8 weeks after begin medication or placebo ] [ Designated as safety issue: No ]
    To evaluate the effects of Lisdexamfetamine on working memory performance and degree of self-control on the delay discounting task after optimal dose is achieved and 8 weeks of treatment, in comparison to baseline and placebo


Secondary Outcome Measures:
  • Secondary Task and Cognitive Measures [ Time Frame: Baseline versus 8 weeks after starting on lisdesxamfetamine or placebo. ] [ Designated as safety issue: No ]
    Assess the effects of Lisdexamfetamine on risk taking as assessed by a computerized risk taking task.

  • Task-related brain connectivity [ Time Frame: 8 weeks after medication (or placebo) in comparison to baseline ] [ Designated as safety issue: No ]
    Connectivity between cognitive control and reward related brain regions will be compared between active treatment versus placebo.

  • Personalized daily goal changes [ Time Frame: Baseline versus 8 weeks into the medication (or placebo). ] [ Designated as safety issue: No ]
    Assess the effects of LDX on successful completion on individualized and personalized daily goals.

  • ADHD Ratings - ASRS [ Time Frame: Baseline and 8 weeks after the subject is randomized to placebo or medication ] [ Designated as safety issue: No ]
    ADHD ratings of behavior.

  • Automobile driving [ Time Frame: Baseline and 8 weeks after randomized to placebo or medication. ] [ Designated as safety issue: No ]
    Assessment of automobile driving for persons who are old enough to drive using the Barkley Driving Scale.

  • Executive functioning [ Time Frame: Baseline and 8 weeks after randomization to placebo or active condition ] [ Designated as safety issue: No ]
    Measures of executive functioning, including the BRIEF and other similar measures.

  • Quality and type of interaction measures [ Time Frame: Baseline and 8 weeks after randomized to placebo or medication condition. ] [ Designated as safety issue: No ]
    Qualify of life and functional behavioral measures.


Other Outcome Measures:
  • Pupillometry Measures Collected During fMRI Acquisition [ Time Frame: Baseline versus 8 weeks after start medication or placebo. ] [ Designated as safety issue: No ]
    We will assess for changes in pupil dynamics, including how pupil diameter may work as a marker to assess medication response.

  • Clinical Global Impression Ratings [ Time Frame: Baseline compared to 8 weeks after start in trial. ] [ Designated as safety issue: No ]
    Assess for changes in the Clinical Global Impression Ratings


Estimated Enrollment: 40
Study Start Date: February 2014
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo

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

Experimental: Lisdexamfetamine

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

Drug: Lisdexamfetamine
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 20 mg increments.
Other Name: Vyvanse

  Eligibility

Ages Eligible for Study:   12 Years to 25 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. The subject is a male or female adolescent or young adult, between the ages of 12 and 25 (inclusive) at the time of the initial signing of the informed consent/assent
  2. 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.
  3. This includes a history of childhood symptoms of ADHD for the adult subjects
  4. 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
  5. 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.
  6. 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.
  7. 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

Exclusion Criteria:

  • Clinical contraindications

    1. History of schizophrenia, bipolar disorder, autism spectrum disorder, specific or focal neurological disorder
    2. Current academic learning disorder(s)
    3. Abnormal cardiac functioning with be excluded
    4. The subject experiences Adverse Events during the trial that would, in the investigator's judgment, preclude further exposure to LDX
    5. 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
    6. 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.
    7. Subjects with an inability to swallow tablets or tolerate oral medication
    8. It is in the investigator's opinion that it is not in the subject's best interest to continue
    9. 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

    1. Agents that lower blood levels of amphetamines: urinary acidifying agents (e.g. ammonium chloride, sodium acid phosphate, etc.); Methenamine Therapy.
    2. Agents that increase blood levels of amphetamines: urinary alkalinizing agents (e.g. Acetazolamide, some Thiazides).
    3. 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.
    4. Agents whose effects may be reduced by amphetamines: Adrenergic blockers, Antihistamines, Antihypertensives, Veratrum Alkaloids, Ethosuximide.
    5. Agents whose effects may be potentiated by amphetamines: Tricyclic antidepressants, meperidine, Norepinephrine, Phenobarbital, Phenytoin.
    6. 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

    1. A positive drug screen for cocaine or other drugs of abuse (excluding caffeine, nicotine or prescribed psychostimulants for ADD/ADHD)
    2. 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02170298

Contacts
Contact: Cynthia Krafft, PhD 916 703 0231 Cynthia.krafft@ucdmc.ucdavis.edu
Contact: Tadeus A Hartanto, BS 916 703 0294 tadeus.hartanto@ucdmc.ucdavis.edu

Locations
United States, California
UC Davis MIND Institute Recruiting
Sacramento, California, United States, 95817
Contact: Cynthia Krafft, PhD    916-703-0231    Cynthia.Krafft@ucdmc.ucdavis.edu   
Contact: Tadeus A Hartanto, BS    916 703 0294    tadeus.hartanto@ucdmc.ucdavis.edu   
Principal Investigator: Julie B Schweitzer, PhD         
Sponsors and Collaborators
University of California, Davis
Shire
Investigators
Principal Investigator: Julie B Schweitzer, PhD University of California, Davis
  More Information

No publications provided

Responsible Party: Julie Schweitzer, Professor of Clinical Psychiatry, University of California, Davis
ClinicalTrials.gov Identifier: NCT02170298     History of Changes
Other Study ID Numbers: 402395
Study First Received: June 11, 2014
Last Updated: June 17, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Davis:
ADHD
Attention Deficit Hyperactivity Disorder
Vyvanse
Lisdexamfetamine

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Attention Deficit and Disruptive Behavior Disorders
Dyskinesias
Mental Disorders
Mental Disorders Diagnosed in Childhood
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Dextroamphetamine
Central Nervous System Agents
Central Nervous System Stimulants
Dopamine Agents
Dopamine Uptake Inhibitors
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014