Trial Outcomes & Findings for Shire SCT: Lisdexamfetamine Treatment for ADHD and SCT (NCT NCT02635035)

Last Updated: 2021-11-16

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

38 participants

Primary outcome timeframe

Baseline, 10 Weeks

Results posted on

2021-11-16

Participant Flow

Participant milestones

Participant milestones
Measure	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.	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.
Overall Study STARTED	17	21
Overall Study COMPLETED	17	21
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Shire SCT: Lisdexamfetamine Treatment for ADHD and SCT

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Lisdexamfetamine First n=17 Participants 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.	Lisdexamfetamine Second n=21 Participants 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 n=38 Participants Total of all reporting groups
Age, Continuous	31.06 years STANDARD_DEVIATION 7.92 • n=5 Participants	37.38 years STANDARD_DEVIATION 11.07 • n=7 Participants	34 years STANDARD_DEVIATION 10.21 • n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants	14 Participants n=7 Participants	25 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	7 Participants n=7 Participants	13 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	5 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants	5 Participants n=7 Participants	9 Participants n=5 Participants
Race (NIH/OMB) White	12 Participants n=5 Participants	11 Participants n=7 Participants	23 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	17 participants n=5 Participants	21 participants n=7 Participants	38 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Lisdexamfetamine First n=17 Participants 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.	Lisdexamfetamine Second n=21 Participants 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.
Change in Score on Barkley Adult ADHD Rating Scale-IV (BAARS-IV)	23.27 score on a scale Standard Deviation 7.73	23.1 score on a scale Standard Deviation 7.4

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Lisdexamfetamine First n=17 Participants 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.	Lisdexamfetamine Second n=21 Participants 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.
Change in Score on Barkley Functional Impairment Scale (BFIS)	4.93 units on a scale Standard Deviation 2	4.88 units on a scale Standard Deviation 2.06

Adverse Events

Lisdexamfetamine First

Serious events: 0 serious events

Other events: 16 other events

Deaths: 0 deaths

Lisdexamfetamine Second

Serious events: 0 serious events

Other events: 17 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Terry Leon

NYU Langone Health

Phone: 1 646 754 4841

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place