Shire SCT: Lisdexamfetamine Treatment for ADHD and SCT

• Sponsor: NYU Langone Health (Other)
• Overall Status: Completed
• CT.gov ID: NCT02635035
• Collaborator: Shire (Industry)
• Enrollment: 38
• Locations: 2
• Arms: 2
• Duration (Months): 38.3
• Patients Per Site: 19
• Patients Per Site Per Month: 0.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Attention Deficit Disorder; Attention Deficit Hyperactivity Disorder	Drug: Lisdexamfetamine; Drug: Placebo	Phase 2

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 38 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Efficacy of Lisdexamfetamine in Adults With Attention Deficit Hyperactivity Disorder (ADHD) and Sluggish Cognitive Tempo (SCT)
• Study Start Date: Nov 1, 2015
• Actual Primary Completion Date: Jan 9, 2019
• Actual Study Completion Date: Jan 9, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Lisdexamfetamine First In this crossover study design, participants assigned to this group will receive Lisdexamfetamine first, then placebo second	Drug: 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.; Other Names: Vyvanse ; Drug: Placebo; Placebo looks just like Vyvanse but has no active ingredients, like a sugar pill.
Experimental: Lisdexamfetamine Second In this crossover study design, participants assigned to this group will receive placebo first, then Lisdexamfetamine second	Drug: 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.; Other Names: Vyvanse ; Drug: Placebo; Placebo looks just like Vyvanse but has no active ingredients, like a sugar pill.

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mount Sinai School of Medicine	New York	New York	United States	10016
2	New York University School of Medicine	New York	New York	United States	10016

Sponsors and Collaborators

• NYU Langone Health
• Shire

Investigators

• Principal Investigator: Lenard Adler, M.D., NYU Medical College

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Mar 3, 2016

More Information

Publications

None provided.

• Responsible Party: NYU Langone Health
• ClinicalTrials.gov Identifier: NCT02635035
• Other Study ID Numbers: 13-01288
• First Posted: Dec 18, 2015
• Last Update Posted: Nov 16, 2021
• Last Verified: Oct 1, 2021

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Hyperkinesis; Disease; Attention Deficit Disorder with Hyperactivity; Lisdexamfetamine Dimesylate

Study Results

Participant Flow

Arm/Group Title	Lisdexamfetamine First	Lisdexamfetamine Second
Arm/Group Description	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.	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.
Period Title: Overall Study
STARTED	17	21
COMPLETED	17	21
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Lisdexamfetamine First	Lisdexamfetamine Second	Total
Arm/Group Description	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.	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.	Total of all reporting groups
Overall Participants	17	21	38
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	31.06 (7.92)	37.38 (11.07)	34 (10.21)
Sex: Female, Male (Count of Participants)
Female	11 64.7%	14 66.7%	25 65.8%
Male	6 35.3%	7 33.3%	13 34.2%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	1 5.9%	5 23.8%	6 15.8%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	4 23.5%	5 23.8%	9 23.7%
White	12 70.6%	11 52.4%	23 60.5%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	17 100%	21 100%	38 100%

Outcome Measures

1. Primary Outcome

Title	Change in Score on Barkley Adult ADHD Rating Scale-IV (BAARS-IV)
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Lisdexamfetamine First	Lisdexamfetamine Second
Arm/Group Description	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.	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.
Measure Participants	17	21
Mean (Standard Deviation) [score on a scale]	23.27 (7.73)	23.1 (7.4)

2. Secondary Outcome

Title	Change in Score on Barkley Functional Impairment Scale (BFIS)
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Lisdexamfetamine First	Lisdexamfetamine Second
Arm/Group Description	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.	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.
Measure Participants	17	21
Mean (Standard Deviation) [units on a scale]	4.93 (2)	4.88 (2.06)

Adverse Events

Time Frame	11 weeks
Adverse Event Reporting Description	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/Group Title	Lisdexamfetamine First		Lisdexamfetamine Second
Arm/Group Description	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.		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.
All Cause Mortality
	Lisdexamfetamine First		Lisdexamfetamine Second
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/17 (0%)		0/21 (0%)
Serious Adverse Events
	Lisdexamfetamine First		Lisdexamfetamine Second
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/17 (0%)		0/21 (0%)
Other (Not Including Serious) Adverse Events
	Lisdexamfetamine First		Lisdexamfetamine Second
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	16/17 (94.1%)		17/21 (81%)
Cardiac disorders
Increased Heart Rate	0/17 (0%)	0	1/21 (4.8%)	2
Heart Palpitations	1/17 (5.9%)	1	1/21 (4.8%)	1
increase blood pressure	0/17 (0%)	0	1/21 (4.8%)	1
Increased Pulse	0/17 (0%)	0	1/21 (4.8%)	1
Eye disorders
Rapid Moving Eyes	0/17 (0%)	0	1/21 (4.8%)	1
Blurred Vision	0/17 (0%)	0	1/21 (4.8%)	1
dry eyes	0/17 (0%)	0	1/21 (4.8%)	1
Gastrointestinal disorders
Nausea	2/17 (11.8%)	2	0/21 (0%)	0
Upset Stomach	1/17 (5.9%)	1	1/21 (4.8%)	1
Rectal Bleeding	1/17 (5.9%)	1	0/21 (0%)	0
irritated stomach	1/17 (5.9%)	1	2/21 (9.5%)	2
General disorders
Headache	8/17 (47.1%)	13	5/21 (23.8%)	8
Irritability	0/17 (0%)	0	1/21 (4.8%)	1
Drowsiness	0/17 (0%)	0	1/21 (4.8%)	2
Trouble Sleeping/Falling asleep	3/17 (17.6%)	3	4/21 (19%)	8
Tired	1/17 (5.9%)	1	3/21 (14.3%)	4
Lethargic	0/17 (0%)	0	3/21 (14.3%)	3
Cold	1/17 (5.9%)	2	1/21 (4.8%)	1
Took Extra 50 mg Pill (Vyvanse/Placebo)	0/17 (0%)	0	1/21 (4.8%)	1
Body Aches	0/17 (0%)	0	1/21 (4.8%)	1
Decrease Sleep	1/17 (5.9%)	1	0/21 (0%)	0
over focused on work	1/17 (5.9%)	1	1/21 (4.8%)	1
Strange Taste	0/17 (0%)	0	1/21 (4.8%)	1
weird dreams	0/17 (0%)	0	1/21 (4.8%)	1
insomnia	1/17 (5.9%)	1	4/21 (19%)	4
decreased memory	1/17 (5.9%)	1	0/21 (0%)	0
fatigue	1/17 (5.9%)	1	0/21 (0%)	0
Metabolism and nutrition disorders
Decreased Appetite	5/17 (29.4%)	6	6/21 (28.6%)	8
Decreased Weight	2/17 (11.8%)	2	0/21 (0%)	0
reduced thirst	0/17 (0%)	0	1/21 (4.8%)	1
dehydration	2/17 (11.8%)	2	0/21 (0%)	0
increased appetite	1/17 (5.9%)	1	0/21 (0%)	0
Musculoskeletal and connective tissue disorders
Knee Pain	1/17 (5.9%)	2	1/21 (4.8%)	1
Upper back Pain	0/17 (0%)	0	2/21 (9.5%)	2
Nervous system disorders
Formication	0/17 (0%)	0	1/21 (4.8%)	1
Psychiatric disorders
Anxious/Jittery	1/17 (5.9%)	3	3/21 (14.3%)	4
Mood Lability	0/17 (0%)	0	1/21 (4.8%)	1
withdrawn, subjective feelings	0/17 (0%)	0	1/21 (4.8%)	1
moody	0/17 (0%)	0	2/21 (9.5%)	2
Sadness	1/17 (5.9%)	1	1/21 (4.8%)	1
Mood Changes	0/17 (0%)	0	1/21 (4.8%)	1
Renal and urinary disorders
decreased creatinine	0/17 (0%)	0	1/21 (4.8%)	1
Reproductive system and breast disorders
Difficulty maintaining an Erection	0/17 (0%)	0	1/21 (4.8%)	1
Change in Orgasm	0/17 (0%)	0	0/21 (0%)	0
itchy vagina	0/17 (0%)	0	1/21 (4.8%)	1
Respiratory, thoracic and mediastinal disorders
Dry Mouth	3/17 (17.6%)	3	6/21 (28.6%)	7
Sore Throat	1/17 (5.9%)	2	3/21 (14.3%)	3
Phlegm	1/17 (5.9%)	2	0/21 (0%)	0
Cough	2/17 (11.8%)	2	0/21 (0%)	0
upper respiratory infection	2/17 (11.8%)	2	0/21 (0%)	0
dry sinus	0/17 (0%)	0	1/21 (4.8%)	1
Skin and subcutaneous tissue disorders
Rash on Right Hand	1/17 (5.9%)	1	0/21 (0%)	0
Minor Pain in palm of Left Hand	1/17 (5.9%)	1	0/21 (0%)	0
Sider Bite (Itchy)	1/17 (5.9%)	1	0/21 (0%)	0
dry skin	0/17 (0%)	0	1/21 (4.8%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.