Trial Outcomes & Findings for Placebo Controlled Study of Atomoxetine in the Treatment of Mild to Moderate Cognitive Difficulties in Menopausal Women (NCT NCT00611533)
NCT ID: NCT00611533
Last Updated: 2017-04-17
Results Overview
Raw scores for 5 clusters (organizing/activating, attention/concentration, alertness/effort/processing, managing affect interference, and working memory/recall) on the BADDS were converted to T scores which range from 50-99, with higher scores meaning greater impairment.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
16 participants
Primary outcome timeframe
Baseline and after 6 weeks intervention
Results posted on
2017-04-17
Participant Flow
Participant milestones
| Measure |
Atomoxetine Then Placebo
Subjects were enrolled into a double-blind, placebo-controlled cross over study where they will receive ATX 40mg/d x 1 week, then 80mg/d x 5 weeks or placebo (PBO) for 6 weeks, followed by a 4-week wash out period that is followed by an additional 6 weeks of treatment in the alternate condition. The 4-week washout period include a 4-day taper in the first week. Subjects will be instructed to take one capsule of ATX 40mg/d or placebo per day. If tolerated, the number of pills of ATX will be increased to 2 per day at the end of Week 1 of both Trials A and B. Subjects will remain on two capsules per day for the remaining 5 weeks of Trials A and B.
|
Placebo Then Atomoxetine
Subjects were enrolled into a double-blind, placebo-controlled cross over study where they will receive ATX 40mg/d x 1 week, then 80mg/d x 5 weeks or placebo (PBO) for 6 weeks, followed by a 4-week wash out period that is followed by an additional 6 weeks of treatment in the alternate condition. The 4-week washout period include a 4-day taper in the first week. Subjects will be instructed to take one capsule of ATX 40mg/d or placebo per day. If tolerated, the number of pills of ATX will be increased to 2 per day at the end of Week 1 of both Trials A and B. Subjects will remain on two capsules per day for the remaining 5 weeks of Trials A and B.
|
|---|---|---|
|
First Intervention (6 Weeks)
STARTED
|
8
|
8
|
|
First Intervention (6 Weeks)
COMPLETED
|
8
|
6
|
|
First Intervention (6 Weeks)
NOT COMPLETED
|
0
|
2
|
|
Second Intervention (6 Weeks)
STARTED
|
8
|
6
|
|
Second Intervention (6 Weeks)
COMPLETED
|
8
|
4
|
|
Second Intervention (6 Weeks)
NOT COMPLETED
|
0
|
2
|
Reasons for withdrawal
| Measure |
Atomoxetine Then Placebo
Subjects were enrolled into a double-blind, placebo-controlled cross over study where they will receive ATX 40mg/d x 1 week, then 80mg/d x 5 weeks or placebo (PBO) for 6 weeks, followed by a 4-week wash out period that is followed by an additional 6 weeks of treatment in the alternate condition. The 4-week washout period include a 4-day taper in the first week. Subjects will be instructed to take one capsule of ATX 40mg/d or placebo per day. If tolerated, the number of pills of ATX will be increased to 2 per day at the end of Week 1 of both Trials A and B. Subjects will remain on two capsules per day for the remaining 5 weeks of Trials A and B.
|
Placebo Then Atomoxetine
Subjects were enrolled into a double-blind, placebo-controlled cross over study where they will receive ATX 40mg/d x 1 week, then 80mg/d x 5 weeks or placebo (PBO) for 6 weeks, followed by a 4-week wash out period that is followed by an additional 6 weeks of treatment in the alternate condition. The 4-week washout period include a 4-day taper in the first week. Subjects will be instructed to take one capsule of ATX 40mg/d or placebo per day. If tolerated, the number of pills of ATX will be increased to 2 per day at the end of Week 1 of both Trials A and B. Subjects will remain on two capsules per day for the remaining 5 weeks of Trials A and B.
|
|---|---|---|
|
First Intervention (6 Weeks)
Never started study
|
0
|
1
|
|
First Intervention (6 Weeks)
Adverse Event
|
0
|
1
|
|
Second Intervention (6 Weeks)
Adverse Event
|
0
|
2
|
Baseline Characteristics
Placebo Controlled Study of Atomoxetine in the Treatment of Mild to Moderate Cognitive Difficulties in Menopausal Women
Baseline characteristics by cohort
| Measure |
All Study Participants
n=14 Participants
Subjects were enrolled into a double-blind, placebo-controlled cross over study where they will receive ATX 40mg/d x 1 week, then 80mg/d x 5 weeks or placebo (PBO) for 6 weeks, followed by a 4-week wash out period that is followed by an additional 6 weeks of treatment in the alternate condition. The 4-week washout period include a 4-day taper in the first week. Subjects will be instructed to take one capsule of ATX 40mg/d or placebo per day. If tolerated, the number of pills of ATX will be increased to 2 per day at the end of Week 1 of both Trials A and B. Subjects will remain on two capsules per day for the remaining 5 weeks of Trials A and B.
|
|---|---|
|
Age, Continuous
|
54.0 years
STANDARD_DEVIATION 2.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
14 Participants
n=5 Participants
|
|
Years of education
|
16.4 years
STANDARD_DEVIATION 3.2 • n=5 Participants
|
|
Months since last menstrual period
|
29.3 months
STANDARD_DEVIATION 20.5 • n=5 Participants
|
|
Follicle stimulating hormone
|
76.0 IU/L
STANDARD_DEVIATION 33.8 • n=5 Participants
|
|
Estradiol
|
31.9 pg/mL
STANDARD_DEVIATION 32.9 • n=5 Participants
|
|
Brown attention deficit disorder scale
|
38.6 units on a scale
STANDARD_DEVIATION 20.2 • n=5 Participants
|
|
Participant characteristics
Perimenopausal
|
4 Participants
n=5 Participants
|
|
Participant characteristics
Postmenopausal
|
10 Participants
n=5 Participants
|
|
Participant characteristics
Previous OCP use
|
11 Participants
n=5 Participants
|
|
Participant characteristics
Previous HT use
|
4 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and after 6 weeks interventionPopulation: Participants who completed both interventions.
Raw scores for 5 clusters (organizing/activating, attention/concentration, alertness/effort/processing, managing affect interference, and working memory/recall) on the BADDS were converted to T scores which range from 50-99, with higher scores meaning greater impairment.
Outcome measures
| Measure |
Baseline
n=12 Participants
|
Atomoxetine
n=12 Participants
Atomoxetine: Subjects will receive ATX 40mg/d x 1 week, then 80mg/d x 5 weeks followed by a 4-week wash out period that is followed by an additional 6 weeks of treatment in the alternate condition. The 4-week washout period include a 4-day taper in the first week.
|
Placebo
n=12 Participants
Placebo: Subjects will receive placebo equivalent for 6 weeks followed by a 4-week wash out period that is followed by an additional 6 weeks of treatment in the alternate condition. The 4-week washout period include a 4-day taper in the first week.
|
|---|---|---|---|
|
Brown Attention Deficit Disorder Scale
organizing/activating
|
60.7 T score
Standard Deviation 11.6
|
55.6 T score
Standard Deviation 8.9
|
56.3 T score
Standard Deviation 8.9
|
|
Brown Attention Deficit Disorder Scale
attention/concentration
|
58.8 T score
Standard Deviation 8.7
|
52.1 T score
Standard Deviation 4.0
|
56.4 T score
Standard Deviation 7.1
|
|
Brown Attention Deficit Disorder Scale
alertness/effort/processing
|
57.4 T score
Standard Deviation 10.0
|
54.2 T score
Standard Deviation 5.5
|
54.7 T score
Standard Deviation 7.9
|
|
Brown Attention Deficit Disorder Scale
managing affect interference
|
55.3 T score
Standard Deviation 7.9
|
51.8 T score
Standard Deviation 4.5
|
51.6 T score
Standard Deviation 3.8
|
|
Brown Attention Deficit Disorder Scale
working memory/recall
|
61.3 T score
Standard Deviation 10.0
|
52.4 T score
Standard Deviation 5.3
|
59.6 T score
Standard Deviation 10.3
|
PRIMARY outcome
Timeframe: Baseline and after 6 weeks interventionPopulation: Participants who had at least one post randomization visit.
The total BADDS ranged from 0-120 with higher scores meaning greater problems with memory, attention and focus.
Outcome measures
| Measure |
Baseline
n=14 Participants
|
Atomoxetine
n=14 Participants
Atomoxetine: Subjects will receive ATX 40mg/d x 1 week, then 80mg/d x 5 weeks followed by a 4-week wash out period that is followed by an additional 6 weeks of treatment in the alternate condition. The 4-week washout period include a 4-day taper in the first week.
|
Placebo
n=14 Participants
Placebo: Subjects will receive placebo equivalent for 6 weeks followed by a 4-week wash out period that is followed by an additional 6 weeks of treatment in the alternate condition. The 4-week washout period include a 4-day taper in the first week.
|
|---|---|---|---|
|
BADDS Total Score
|
38.6 units on a scale
Standard Deviation 20.2
|
25.5 units on a scale
Standard Deviation 16.0
|
30.1 units on a scale
Standard Deviation 16.0
|
SECONDARY outcome
Timeframe: Baseline and after 6 weeks interventionPopulation: Participants who had least one post randomization visit.
Outcome measures
| Measure |
Baseline
n=14 Participants
|
Atomoxetine
n=14 Participants
Atomoxetine: Subjects will receive ATX 40mg/d x 1 week, then 80mg/d x 5 weeks followed by a 4-week wash out period that is followed by an additional 6 weeks of treatment in the alternate condition. The 4-week washout period include a 4-day taper in the first week.
|
Placebo
n=14 Participants
Placebo: Subjects will receive placebo equivalent for 6 weeks followed by a 4-week wash out period that is followed by an additional 6 weeks of treatment in the alternate condition. The 4-week washout period include a 4-day taper in the first week.
|
|---|---|---|---|
|
Blood Pressure
systolic BP
|
118.8 mm Hg
Standard Deviation 12.5
|
116.7 mm Hg
Standard Deviation 11.3
|
120.3 mm Hg
Standard Deviation 8.5
|
|
Blood Pressure
diastolic BP
|
74 mm Hg
Standard Deviation 10.0
|
69.8 mm Hg
Standard Deviation 7.7
|
70.7 mm Hg
Standard Deviation 5.2
|
SECONDARY outcome
Timeframe: Baseline and after 6 weeks interventionPopulation: Participants who had at least one post randomization visit.
Outcome measures
| Measure |
Baseline
n=14 Participants
|
Atomoxetine
n=14 Participants
Atomoxetine: Subjects will receive ATX 40mg/d x 1 week, then 80mg/d x 5 weeks followed by a 4-week wash out period that is followed by an additional 6 weeks of treatment in the alternate condition. The 4-week washout period include a 4-day taper in the first week.
|
Placebo
n=14 Participants
Placebo: Subjects will receive placebo equivalent for 6 weeks followed by a 4-week wash out period that is followed by an additional 6 weeks of treatment in the alternate condition. The 4-week washout period include a 4-day taper in the first week.
|
|---|---|---|---|
|
Heart Rate
|
63 beats/min
Standard Deviation 3.2
|
68.8 beats/min
Standard Deviation 8.2
|
66.3 beats/min
Standard Deviation 5.5
|
SECONDARY outcome
Timeframe: Baseline and after 6 weeks interventionPopulation: Participants who had at least one post randomization visit.
Outcome measures
| Measure |
Baseline
n=14 Participants
|
Atomoxetine
n=14 Participants
Atomoxetine: Subjects will receive ATX 40mg/d x 1 week, then 80mg/d x 5 weeks followed by a 4-week wash out period that is followed by an additional 6 weeks of treatment in the alternate condition. The 4-week washout period include a 4-day taper in the first week.
|
Placebo
n=14 Participants
Placebo: Subjects will receive placebo equivalent for 6 weeks followed by a 4-week wash out period that is followed by an additional 6 weeks of treatment in the alternate condition. The 4-week washout period include a 4-day taper in the first week.
|
|---|---|---|---|
|
Weight
|
160.1 lb
Standard Deviation 41.8
|
158.1 lb
Standard Deviation 44.4
|
159.8 lb
Standard Deviation 42.6
|
Adverse Events
Atomoxetine
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Atomoxetine
n=16 participants at risk
Atomoxetine: Subjects will receive ATX 40mg/d x 1 week, then 80mg/d x 5 weeks followed by a 4-week wash out period that is followed by an additional 6 weeks of treatment in the alternate condition. The 4-week washout period include a 4-day taper in the first week.
|
Placebo
n=16 participants at risk
Placebo: Subjects will receive placebo equivalent for 6 weeks followed by a 4-week wash out period that is followed by an additional 6 weeks of treatment in the alternate condition. The 4-week washout period include a 4-day taper in the first week.
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
12.5%
2/16 • Up to 16 weeks study intervention
|
6.2%
1/16 • Up to 16 weeks study intervention
|
|
Cardiac disorders
increase in blood pressure
|
6.2%
1/16 • Up to 16 weeks study intervention
|
0.00%
0/16 • Up to 16 weeks study intervention
|
|
Cardiac disorders
racing heart
|
0.00%
0/16 • Up to 16 weeks study intervention
|
6.2%
1/16 • Up to 16 weeks study intervention
|
|
General disorders
dry mouth
|
0.00%
0/16 • Up to 16 weeks study intervention
|
6.2%
1/16 • Up to 16 weeks study intervention
|
|
Psychiatric disorders
racing thoughts
|
0.00%
0/16 • Up to 16 weeks study intervention
|
6.2%
1/16 • Up to 16 weeks study intervention
|
|
General disorders
insomnia
|
0.00%
0/16 • Up to 16 weeks study intervention
|
6.2%
1/16 • Up to 16 weeks study intervention
|
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