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Attention & Memory Impairments in Menopausal Women

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ClinicalTrials.gov Identifier: NCT01324024
Recruitment Status : Completed
First Posted : March 28, 2011
Results First Posted : June 28, 2017
Last Update Posted : June 28, 2017
Sponsor:
Collaborator:
Shire
Information provided by (Responsible Party):
University of Pennsylvania

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Symptomatic Menopause
Cognitive Impairments
Interventions Drug: Lisdexamfetamine
Drug: Placebo
Enrollment 35
Recruitment Details 55 participants were consented for screening over the course of 2 years at an outpatient research site in Philadelphia, PA.
Pre-assignment Details Of the 55 who were consented for screening, 20 did not meet inclusion criteria and of the remaining 35, 32 participants completed the study.
Arm/Group Title Lisdexamfetamine, Then Placebo Placebo First, Then Lisdexamfetamine
Hide Arm/Group Description 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. 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).
Period Title: First Intervention (4 Weeks)
Started 18 17
Completed 18 17
Not Completed 0 0
Period Title: Washout (2 Weeks)
Started 18 17
Completed 18 17
Not Completed 0 0
Period Title: Second Intervention (4 Weeks)
Started 18 17
Completed 16 16
Not Completed 2 1
Reason Not Completed
Withdrawal by Subject             2             1
Arm/Group Title All Study Participants
Hide Arm/Group Description Participants were randomized to receive either Lisdexampethamine in titrated doses (20mg/d- 60mg/d) or Placebo tablets (matching Lisdexamphetamine).
Overall Number of Baseline Participants 32
Hide Baseline Analysis Population Description
Of the 55 subjects who were consented for screening, 20 were excluded and of the remaining 35 subjects, 32 completed both active and placebo treatment trials. There were 3 subjects who withdrew themselves from the study. These 3 subjects are not included in the overall number of baseline participants analyzed.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 32 participants
<=18 years
0
   0.0%
Between 18 and 65 years
32
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 32 participants
53.1  (2.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 32 participants
Female
32
 100.0%
Male
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 32 participants
Hispanic or Latino
2
   6.3%
Not Hispanic or Latino
30
  93.8%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 32 participants
American Indian or Alaska Native
1
   3.1%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
7
  21.9%
White
22
  68.8%
More than one race
2
   6.3%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 32 participants
32
1.Primary Outcome
Title Brown Attention Deficit Disorder Scale (BADDS)
Hide Description 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.
Time Frame Baseline, end of first Intervention (4 weeks) and end of second Intervention (4 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Baseline Lisdexamfetamine Sugar Pill
Hide Arm/Group Description:
[Not Specified]
Participants who received Lisdexamfetamine 20

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.

Overall Number of Participants Analyzed 35 32 32
Mean (Standard Deviation)
Unit of Measure: units on a scale
35.7  (16.8) 21.2  (16.8) 29.8  (17.7)
2.Secondary Outcome
Title Penn Continuous Performance Test
Hide Description 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.
Time Frame Baseline, end of first Intervention (4 weeks) and end of second Intervention (4 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Baseline Lisdexamfetamine Sugar Pill
Hide Arm/Group Description:
[Not Specified]

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.

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.

Overall Number of Participants Analyzed 35 32 32
Mean (Standard Deviation)
Unit of Measure: units on a scale
53.29  (3.78) 56.37  (3.59) 56.21  (3.27)
3.Secondary Outcome
Title NYU Paragraph Recall Task
Hide Description 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.
Time Frame Baseline, end of first Intervention (4 weeks) and end of second Intervention (4 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Baseline Lisdexamfetamine Placebo
Hide Arm/Group Description:
[Not Specified]
Participants 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).
Participants received Placebo tablets (matching Lisdexamfetamine tablets) each day for 4 weeks.
Overall Number of Participants Analyzed 35 32 32
Mean (Standard Deviation)
Unit of Measure: units on a scale
Immediate paragraph recall A 7.09  (2.56) 7.48  (2.63) 7.00  (2.70)
Immediate paragraph recall B 6.38  (2.12) 7.45  (3.20) 6.75  (2.53)
Delayed paragraph recall A 4.68  (2.65) 5.90  (3.38) 4.94  (3.02)
Delayed paragraph recall B 7.81  (3.58) 9.77  (3.53) 8.47  (2.97)
Time Frame From study start to study completion only
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Lisdexamfetamine Sugar Pill
Hide Arm/Group Description

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.

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.

All-Cause Mortality
Lisdexamfetamine Sugar Pill
Affected / at Risk (%) Affected / at Risk (%)
Total   0/32 (0.00%)      0/32 (0.00%)    
Hide Serious Adverse Events
Lisdexamfetamine Sugar Pill
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/32 (0.00%)      0/32 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Lisdexamfetamine Sugar Pill
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   6/32 (18.75%)      1/32 (3.13%)    
Cardiac disorders     
increased heart rate  [1]  1/32 (3.13%)  1 1/32 (3.13%)  1
Eye disorders     
eye irritation  [2]  1/32 (3.13%)  1 0/32 (0.00%)  0
Gastrointestinal disorders     
diverticulitis  [3]  2/32 (6.25%)  2 0/32 (0.00%)  0
General disorders     
mouth sensitivity  [4]  2/32 (6.25%)  2 0/32 (0.00%)  0
dizziness  [5]  0/32 (0.00%)  0 1/32 (3.13%)  1
Indicates events were collected by systematic assessment
[1]
One subject experienced an increased heart in response to the active study drug.
[2]
One subject experienced eye irritation in response to active study drug.
[3]
2 participants experienced symptoms of diverticulitis while on active study drug. Both were hospitalized for a day or less. One received antibiotic treatment and both stopped drug for a short period of time.
[4]
2 subjects experienced gum and tongue sensitivity while on active study drug.
[5]
One subject experienced dizziness in response to placebo pill.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Cynthia Neill Epperson, M.D.
Organization: University of Pennsylvania
Phone: 215-573-8871
EMail: cepp@mail.med.upenn.edu
Layout table for additonal information
Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01324024    
Other Study ID Numbers: 812470
First Submitted: March 24, 2011
First Posted: March 28, 2011
Results First Submitted: May 11, 2016
Results First Posted: June 28, 2017
Last Update Posted: June 28, 2017