Lisdexamfetamine's Effect In ADHD in the Brain and Cognition (NCT02170298) | Clinical Trial Compass
TerminatedPhase 4
Lisdexamfetamine's Effect In ADHD in the Brain and Cognition
Stopped: Lack of enrollment
United States6 participantsStarted 2014-02
Plain-language 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.
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.
Who can participate
Age range12 Years – 30 Years
SexALL
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Inclusion criteria
✓. 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
Exclusion criteria
✕. 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
✕. 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