Attention Deficit Disorder, Attention Deficit Hyperactivity Disorder
Conditions
Brief summary
The primary purpose of this study is to test the efficacy of Lisdexamfetamine in Adults With Attention Deficit Hyperactivity Disorder (ADHD) and Sluggish Cognitive Tempo (SCT). This is a placebo controlled, cross-over clinical trial of oral Lisdexamfetamine Dimesylate 30-70mg/day in adults with attention-deficit hyper-activity disorder and Sluggish Cognitive Tempo (ACT). Patients will be assigned either LDX/Placebo for 10 weeks with a two week placebo washout period.
Detailed description
Sluggish Cognitive Tempo (SCT) describes individuals who are dreamy, spacey, slow moving, hyper active, have difficulty initiating tasks, and often seem under-motivated and under-aroused. Barkley identified nine cardinal symptoms of SCT: 1) prone to daydreaming instead of concentrating; 2) trouble staying alert/awake in boring situations; 3) being easily confused; 4) being easily bored; 5) feeling spacey/in a fog; 6) frequently feeling lethargic; 7) being under-active/having less energy than others; 8) being slow moving; 9) not processing information quickly/accurately. Individuals were identified as SCT if they had at least 5 of 9 symptoms rated often or very often on the 9-item SCT subscale from the Barkley Adult ADHD Rating Scale-IV: Self-Report (BAARS-IV; hereafter called the Barkley SCT Scale). This is a 2 Site (NYU and Mount Sinai) Study of LDX in 50 adults with Attention Deficit Disorder (ADHD) and Sluggish Cognitive Tempo (SCT). The study will be a double-blind, 10-week, cross-over treatment trial of LDX (4 weeks; 30 - 70 mg/day) vs. placebo (4 weeks) with an intervening single- blind placebo washout period (2 weeks). During the LDX treatment period, LDX treatment will be initiated at a dose of 30mg/day at Visit 0 and can be titrated up (in the judgment of the investigator) in increments of 20mg, based upon clinical response and tolerability, to 50mg/day at Visit 1 and 70mg/day at Visit 2. Subjects receiving daily doses of 50mg or 70mg of LDX will be allowed to down titrate one dosage step of 20mg during Visits 2-4 if (in the judgment of the investigator) they are having issues in tolerability. The highest effective dose of LDX will then be maintained until Visit 4. Patients will be seen weekly throughout the trial except during placebo washout.
Interventions
DRUGLisdexamfetamine
Vyvanse (Lisdexamfetamine Dimesylate) manufactured by Shire, is a Drug Enforcement Administration (DEA) class two,sympathomimetic amine, used for the treatment of attention-deficit hyperactivity disorder. The initial adult dosage is 30mg with allowed adjustments in increments of 10mg or 20mg at weekly intervals. Subjects are initiated on these doses and then they were titrated up by 20mg with a maximum dose of 70mg.
DRUGPlacebo
Placebo looks just like Vyvanse but has no active ingredients, like a sugar pill.
Sponsors
Shire
NYU Langone Health
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
1. Male or female between the ages of 18-60 of all races and ethnicity. 2. Meets DSM-IV-TR criteria for a primary diagnosis of inattentive or combined type ADHD as diagnosed via the Adult ADHD Clinician Diagnostic Scale 3. For the Sluggish Cognitive Tempo+ group Must Score ≥ 5 items on the Barkley Sluggish Cognitive Tempo Scale; Must be rated 3 (often) or (very often) and total Sluggish Cognitive Tempo symptom score ≥ 26; must have a T-score ≥ 65 on the Metacognition Index and Motivation Subscales of the Behavior RatingInventory of Executive Function - Adult Version (BRIEF-A) 4. Impairment: must have a total score \> 95th percentile on the Barkley Functional Impairment Rating Screen (Barkley Functional Impairment Scale (BFIS). 5. For the Sluggish Cognitive Tempo - group, \< 5 items on the Barkley SCT Scale must be rated 3 (often) or 4 (very often) and total SCT symptom score \< 26; must have a T-score \< 65 on the Metacognition Index and Motivation Subscales of the BRIEF-A.
Exclusion criteria
1. Meets DSM-IV-TR criteria for a primary diagnosis of hyperactive-impulsive type ADHD. 2. Any other current psychiatric disorder, determined via the M.I.N.I , which requires pharmacotherapy treatment. 3. Current suicidal ideation or history of suicide attempts, based on the Columbia- Suicide Severity Rating Scale(C-SSRS). 4. Lifetime history of bipolar disorder or any psychotic disorder as per the M.I.N.I 5. Pregnant, breastfeeding or women planning to become pregnant. 6. Positive urine drug toxicology are excluded.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Lisdexamfetamine First In this crossover study design, participants assigned to this group will receive Lisdexamfetamine first, then placebo second
Lisdexamfetamine: Vyvanse (Lisdexamfetamine Dimesylate) manufactured by Shire, is a Drug Enforcement Administration (DEA) class two,sympathomimetic amine, used for the treatment of attention-deficit hyperactivity disorder. The initial adult dosage is 30mg with allowed adjustments in increments of 10mg or 20mg at weekly intervals. Subjects are initiated on these doses and then they were titrated up by 20mg with a maximum dose of 70mg.
Placebo: Placebo looks just like Vyvanse but has no active ingredients, like a sugar pill. | 17 |
| Lisdexamfetamine Second In this crossover study design, participants assigned to this group will receive placebo first, then Lisdexamfetamine second
Lisdexamfetamine: Vyvanse (Lisdexamfetamine Dimesylate) manufactured by Shire, is a Drug Enforcement Administration (DEA) class two,sympathomimetic amine, used for the treatment of attention-deficit hyperactivity disorder. The initial adult dosage is 30mg with allowed adjustments in increments of 10mg or 20mg at weekly intervals. Subjects are initiated on these doses and then they were titrated up by 20mg with a maximum dose of 70mg.
Placebo: Placebo looks just like Vyvanse but has no active ingredients, like a sugar pill. | 21 |
| Total | 38 |
Baseline characteristics
| Characteristic | Lisdexamfetamine First | Total | Lisdexamfetamine Second |
|---|---|---|---|
| Age, Continuous | 31.06 years STANDARD_DEVIATION 7.92 | 34 years STANDARD_DEVIATION 10.21 | 37.38 years STANDARD_DEVIATION 11.07 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 6 Participants | 5 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 9 Participants | 5 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 12 Participants | 23 Participants | 11 Participants |
| Region of Enrollment United States | 17 participants | 38 participants | 21 participants |
| Sex: Female, Male Female | 11 Participants | 25 Participants | 14 Participants |
| Sex: Female, Male Male | 6 Participants | 13 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 17 | 0 / 21 |
| other Total, other adverse events | 16 / 17 | 17 / 21 |
| serious Total, serious adverse events | 0 / 17 | 0 / 21 |
Outcome results
Primary
Change in Score on Barkley Adult ADHD Rating Scale-IV (BAARS-IV)
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.
Time frame: Baseline, 10 Weeks
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lisdexamfetamine First | Change in Score on Barkley Adult ADHD Rating Scale-IV (BAARS-IV) | 23.27 score on a scale | Standard Deviation 7.73 |
| Lisdexamfetamine Second | Change in Score on Barkley Adult ADHD Rating Scale-IV (BAARS-IV) | 23.1 score on a scale | Standard Deviation 7.4 |
Secondary
Change in Score on Barkley Functional Impairment Scale (BFIS)
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.
Time frame: Baseline, 10 weeks
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lisdexamfetamine First | Change in Score on Barkley Functional Impairment Scale (BFIS) | 4.93 units on a scale | Standard Deviation 2 |
| Lisdexamfetamine Second | Change in Score on Barkley Functional Impairment Scale (BFIS) | 4.88 units on a scale | Standard Deviation 2.06 |