Trial Outcomes & Findings for Attention & Memory Impairments in Menopausal Women (NCT NCT01324024)

Last Updated: 2017-06-28

Results Overview

The BADDS questionnaire is a clinician administered questionnaire that assesses the frequency and severity of five clusters of symptoms reflective of executive dysfunction reported by individuals with ADHD. Participants are asked to rate the frequency and severity of a symptom on a scale from 0 to 3, with 0 meaning that the problem described does not relate to them and 3 indicating that the problem is very true for them and occurs almost daily. The range of severity for the total BADDS score is 0 to 120, with scores of 55 and above being consistent with full-syndrome ADHD.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

35 participants

Primary outcome timeframe

Baseline, end of first Intervention (4 weeks) and end of second Intervention (4 weeks)

Results posted on

2017-06-28

Participant Flow

55 participants were consented for screening over the course of 2 years at an outpatient research site in Philadelphia, PA.

Of the 55 who were consented for screening, 20 did not meet inclusion criteria and of the remaining 35, 32 participants completed the study.

Participant milestones

Participant milestones
Measure	Lisdexamfetamine, Then Placebo Participants first received titrated doses of Lisdexamfetamine 20 to 60 mg/d each day for 4 weeks (i.e, 20mg/d for 1 week, 40mg/d for 1 week and 60mg/d for 2 weeks) followed by a 2-week washout, then they received Placebo tablets (matching Lisdexamfetamine tablets) each day for 4 weeks.	Placebo First, Then Lisdexamfetamine Participants first received Placebo tablets (matching Lisdexamfetamine tablets) each day for 4 weeks, followed by a 2-week washout, then they received titrated doses of Lisdexamfetamine 20 to 60 mg/d each day for 4 weeks (i.e, 20mg/d for 1 week, 40mg/d for 1 week and 60mg/d for 2 weeks).
First Intervention (4 Weeks) STARTED	18	17
First Intervention (4 Weeks) COMPLETED	18	17
First Intervention (4 Weeks) NOT COMPLETED	0	0
Washout (2 Weeks) STARTED	18	17
Washout (2 Weeks) COMPLETED	18	17
Washout (2 Weeks) NOT COMPLETED	0	0
Second Intervention (4 Weeks) STARTED	18	17
Second Intervention (4 Weeks) COMPLETED	16	16
Second Intervention (4 Weeks) NOT COMPLETED	2	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Lisdexamfetamine, Then Placebo Participants first received titrated doses of Lisdexamfetamine 20 to 60 mg/d each day for 4 weeks (i.e, 20mg/d for 1 week, 40mg/d for 1 week and 60mg/d for 2 weeks) followed by a 2-week washout, then they received Placebo tablets (matching Lisdexamfetamine tablets) each day for 4 weeks.	Placebo First, Then Lisdexamfetamine Participants first received Placebo tablets (matching Lisdexamfetamine tablets) each day for 4 weeks, followed by a 2-week washout, then they received titrated doses of Lisdexamfetamine 20 to 60 mg/d each day for 4 weeks (i.e, 20mg/d for 1 week, 40mg/d for 1 week and 60mg/d for 2 weeks).
Second Intervention (4 Weeks) Withdrawal by Subject	2	1

Baseline Characteristics

Attention & Memory Impairments in Menopausal Women

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Study Participants n=32 Participants Participants were randomized to receive either Lisdexampethamine in titrated doses (20mg/d- 60mg/d) or Placebo tablets (matching Lisdexamphetamine).
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	32 Participants n=99 Participants
Age, Categorical >=65 years	0 Participants n=99 Participants
Age, Continuous	53.1 years STANDARD_DEVIATION 2.8 • n=99 Participants
Sex: Female, Male Female	32 Participants n=99 Participants
Sex: Female, Male Male	0 Participants n=99 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=99 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	30 Participants n=99 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=99 Participants
Race (NIH/OMB) Asian	0 Participants n=99 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants
Race (NIH/OMB) Black or African American	7 Participants n=99 Participants
Race (NIH/OMB) White	22 Participants n=99 Participants
Race (NIH/OMB) More than one race	2 Participants n=99 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants
Region of Enrollment United States	32 participants n=99 Participants

PRIMARY outcome

Timeframe: Baseline, end of first Intervention (4 weeks) and end of second Intervention (4 weeks)

Population: Of the 55 participants who were consented for screening, 20 were excluded. Of the remaining 35 subjects, 32 completed both active and placebo treatment trials. The numbers in the lisdexamphetamine and placebo arms reflect the fact that 32 subjects completed both arms. 35 total participant data was analyzed for the baseline arm.

Outcome measures

Outcome measures
Measure	Baseline n=35 Participants	Lisdexamfetamine n=32 Participants Participants who received Lisdexamfetamine 20	Sugar Pill n=32 Participants Placebo pill, capsules Lisdexamfetamine: The purpose of this study is to assess whether or not lisdexamfetamine is effective in alleviating cognitive disruptions when compared to a placebo.
Brown Attention Deficit Disorder Scale (BADDS)	35.7 units on a scale Standard Deviation 16.8	21.2 units on a scale Standard Deviation 16.8	29.8 units on a scale Standard Deviation 17.7

SECONDARY outcome

Timeframe: Baseline, end of first Intervention (4 weeks) and end of second Intervention (4 weeks)

Population: The numbers in the lisdexamphetamine and placebo arms reflect the fact that 32 subjects completed both arms; 16 participants in each arm. 35 total participant data was analyzed for the baseline arm.

The Penn Continuous Performance Test is a measure of visual attention and vigilance. In this task, a series of red vertical and horizontal lines flash in a digital numeric frame. The participant must press the spacebar whenever the lines form complete numbers or complete letters. The minimum to maximum score range for this task is 0-60 correct responses, with 60 being a perfect score. This data presented in the outcome measure table reflects the total number of correct responses.

Outcome measures

Outcome measures
Measure	Baseline n=35 Participants	Lisdexamfetamine n=32 Participants Participants who received Lisdexamfetamine 20	Sugar Pill n=32 Participants Placebo pill, capsules Lisdexamfetamine: The purpose of this study is to assess whether or not lisdexamfetamine is effective in alleviating cognitive disruptions when compared to a placebo.
Penn Continuous Performance Test	53.29 units on a scale Standard Deviation 3.78	56.37 units on a scale Standard Deviation 3.59	56.21 units on a scale Standard Deviation 3.27

SECONDARY outcome

Timeframe: Baseline, end of first Intervention (4 weeks) and end of second Intervention (4 weeks)

Subjects hear 2 brief narratives, each containing 19-21 informational bits, and are asked to recall as many details as possible immediately after hearing each paragraph (A and B) and again following a 30 minute delay. Subjects receive credit for each informational bit recalled verbatim. Different paragraphs were read at each assessment. The maximum number of correct responses for paragraph A is 19 and the maximum number of correct responses for paragraph B is 21.

Outcome measures

Outcome measures
Measure	Baseline n=35 Participants	Lisdexamfetamine n=32 Participants Participants who received Lisdexamfetamine 20	Sugar Pill n=32 Participants Placebo pill, capsules Lisdexamfetamine: The purpose of this study is to assess whether or not lisdexamfetamine is effective in alleviating cognitive disruptions when compared to a placebo.
NYU Paragraph Recall Task Immediate paragraph recall A	7.09 units on a scale Standard Deviation 2.56	7.48 units on a scale Standard Deviation 2.63	7.00 units on a scale Standard Deviation 2.70
NYU Paragraph Recall Task Immediate paragraph recall B	6.38 units on a scale Standard Deviation 2.12	7.45 units on a scale Standard Deviation 3.20	6.75 units on a scale Standard Deviation 2.53
NYU Paragraph Recall Task Delayed paragraph recall A	4.68 units on a scale Standard Deviation 2.65	5.90 units on a scale Standard Deviation 3.38	4.94 units on a scale Standard Deviation 3.02
NYU Paragraph Recall Task Delayed paragraph recall B	7.81 units on a scale Standard Deviation 3.58	9.77 units on a scale Standard Deviation 3.53	8.47 units on a scale Standard Deviation 2.97

Adverse Events

Lisdexamfetamine

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Sugar Pill

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Lisdexamfetamine n=32 participants at risk Lisdexamfetamine or Vyvanse Lisdexamfetamine: The purpose of this study is to assess whether or not lisdexamfetamine is effective in alleviating cognitive disruptions when compared to a placebo.	Sugar Pill n=32 participants at risk Placebo pill, capsules Lisdexamfetamine: The purpose of this study is to assess whether or not lisdexamfetamine is effective in alleviating cognitive disruptions when compared to a placebo.
Gastrointestinal disorders diverticulitis	6.2% 2/32 • Number of events 2 • From study start to study completion only	0.00% 0/32 • From study start to study completion only
Cardiac disorders increased heart rate	3.1% 1/32 • Number of events 1 • From study start to study completion only	3.1% 1/32 • Number of events 1 • From study start to study completion only
General disorders mouth sensitivity	6.2% 2/32 • Number of events 2 • From study start to study completion only	0.00% 0/32 • From study start to study completion only
General disorders dizziness	0.00% 0/32 • From study start to study completion only	3.1% 1/32 • Number of events 1 • From study start to study completion only
Eye disorders eye irritation	3.1% 1/32 • Number of events 1 • From study start to study completion only	0.00% 0/32 • From study start to study completion only

Additional Information

Cynthia Neill Epperson, M.D.

University of Pennsylvania

Phone: 215-573-8871

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place