Trial Outcomes & Findings for LDX and Functional Magnetic Resonance Imaging (fMRI in Menopausal Women (NCT NCT01977625)
NCT ID: NCT01977625
Last Updated: 2018-07-27
Results Overview
Blood-oxygen-level dependent contrast imaging, or BOLD-contrast imaging, is a method used in functional magnetic resonance imaging (fMRI) to observe different areas of the brain or other organs, which are found to be active at any given time. BOLD signals were compared from baseline, first intervention and second intervention.
COMPLETED
PHASE4
18 participants
10 weeks
2018-07-27
Participant Flow
18 participants were recruited from the parent study NCT01324024 to complete 3 brain imaging scans.
Of the 18 participants who were recruited, they all were deemed eligible based on the criteria for the parent study NCT01324024. In addition, they must have been deemed eligible to undergo a functional brain imaging scan. Of these 18 participants, 14 completed all 3 scans.
Participant milestones
| Measure |
Lisdexamfetamine, Then Placebo
Participants first received titrated doses of Lisdexamfetamine 20 to 60 mg/d each day for 4 weeks followed by a 2-week washout, then they received Placebo tablets (matching Lisdexamfetamine tablets) each day for 4 weeks.
|
Placebo, 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..
|
|---|---|---|
|
First Intervention (4 Weeks)
STARTED
|
11
|
7
|
|
First Intervention (4 Weeks)
COMPLETED
|
8
|
7
|
|
First Intervention (4 Weeks)
NOT COMPLETED
|
3
|
0
|
|
Washout (2 Weeks)
STARTED
|
8
|
7
|
|
Washout (2 Weeks)
COMPLETED
|
8
|
7
|
|
Washout (2 Weeks)
NOT COMPLETED
|
0
|
0
|
|
Second Intervention (4 Weeks)
STARTED
|
8
|
7
|
|
Second Intervention (4 Weeks)
COMPLETED
|
7
|
7
|
|
Second Intervention (4 Weeks)
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Lisdexamfetamine, Then Placebo
Participants first received titrated doses of Lisdexamfetamine 20 to 60 mg/d each day for 4 weeks followed by a 2-week washout, then they received Placebo tablets (matching Lisdexamfetamine tablets) each day for 4 weeks.
|
Placebo, 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..
|
|---|---|---|
|
First Intervention (4 Weeks)
Withdrawal by Subject
|
3
|
0
|
|
Second Intervention (4 Weeks)
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
LDX and Functional Magnetic Resonance Imaging (fMRI in Menopausal Women
Baseline characteristics by cohort
| Measure |
All Participants
n=18 Participants
Participants first received titrated doses of Lisdexamfetamine 20 to 60 mg/d each day for 4 weeks followed by a 2-week washout, then they received Placebo tablets (matching Lisdexamfetamine tablets) each day for 4 weeks.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
18 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
53.5 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
18 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
18 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 10 weeksPopulation: All participants who completed all phases of the study were included in the outcome analysis.
Blood-oxygen-level dependent contrast imaging, or BOLD-contrast imaging, is a method used in functional magnetic resonance imaging (fMRI) to observe different areas of the brain or other organs, which are found to be active at any given time. BOLD signals were compared from baseline, first intervention and second intervention.
Outcome measures
| Measure |
Lisdexamfetamine
n=14 Participants
Lisdexamfetamine or Vyvanse
Lisdexamfetamine: The overall objective of this study is to assess the effects of LDX on brain activation patterns during tasks of sustained attention and working memory in menopausal women.
|
Placebo
n=14 Participants
Placebo pill, capsules
Placebo: To assess the effects of a placebo pill on brain activation patterns during tasks of sustained attention and working memory in menopausal women.
|
|---|---|---|
|
Percent Change in Blood Oxygen Level Dependent (BOLD) Signal
|
0.41 percent change
Standard Deviation 0.65
|
-0.11 percent change
Standard Deviation 0.46
|
SECONDARY outcome
Timeframe: 10 weeksPopulation: Participants who completed all 3 scans.
The total BADDS ranged from 0-120 with higher scores meaning greater problems with memory, attention and focus. Difference in BADDS score from Baseline to End of Treatment for each study Arm was calculated.
Outcome measures
| Measure |
Lisdexamfetamine
n=14 Participants
Lisdexamfetamine or Vyvanse
Lisdexamfetamine: The overall objective of this study is to assess the effects of LDX on brain activation patterns during tasks of sustained attention and working memory in menopausal women.
|
Placebo
n=14 Participants
Placebo pill, capsules
Placebo: To assess the effects of a placebo pill on brain activation patterns during tasks of sustained attention and working memory in menopausal women.
|
|---|---|---|
|
Change in BADDS Total Score
|
-23.36 change in units
Standard Deviation 11.57
|
-8.57 change in units
Standard Deviation 12.51
|
Adverse Events
Lisdexamfetamine
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Lisdexamfetamine
n=15 participants at risk
Participants first received titrated doses of Lisdexamfetamine 20 to 60 mg/d each day for 4 weeks followed by a 2-week washout, then they received Placebo tablets (matching Lisdexamfetamine tablets) each day for 4 weeks.
|
Placebo
n=15 participants at risk
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.
|
|---|---|---|
|
Cardiac disorders
Increase heart rate
|
6.7%
1/15 • Number of events 1
|
0.00%
0/15
|
|
Cardiac disorders
Increase blood pressure
|
0.00%
0/15
|
6.7%
1/15 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place