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Placebo Controlled Study of Atomoxetine in the Treatment of Mild to Moderate Cognitive Difficulties in Menopausal Women

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ClinicalTrials.gov Identifier: NCT00611533
Recruitment Status : Completed
First Posted : February 11, 2008
Results First Posted : March 3, 2017
Last Update Posted : April 17, 2017
Sponsor:
Collaborator:
Eli Lilly and Company
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 Menopause
Cognitive Disturbances
Interventions Drug: atomoxetine
Drug: placebo
Enrollment 16
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Atomoxetine Then Placebo Placebo Then Atomoxetine
Hide Arm/Group Description 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. 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.
Period Title: First Intervention (6 Weeks)
Started 8 8
Completed 8 6
Not Completed 0 2
Reason Not Completed
Never started study             0             1
Adverse Event             0             1
Period Title: Second Intervention (6 Weeks)
Started 8 6
Completed 8 4
Not Completed 0 2
Reason Not Completed
Adverse Event             0             2
Arm/Group Title All Study Participants
Hide Arm/Group Description 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.
Overall Number of Baseline Participants 14
Hide Baseline Analysis Population Description
Participants who had at least one post randomization visit.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 14 participants
54.0  (2.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants
Female
14
 100.0%
Male
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 14 participants
14
 100.0%
Years of education  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 14 participants
16.4  (3.2)
Months since last menstrual period  
Mean (Standard Deviation)
Unit of measure:  Months
Number Analyzed 14 participants
29.3  (20.5)
Follicle stimulating hormone  
Mean (Standard Deviation)
Unit of measure:  IU/L
Number Analyzed 14 participants
76.0  (33.8)
Estradiol  
Mean (Standard Deviation)
Unit of measure:  pg/mL
Number Analyzed 14 participants
31.9  (32.9)
Brown attention deficit disorder scale   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 14 participants
38.6  (20.2)
[1]
Measure Description: The total BADDS ranged from 0-120, with higher scores meaning greater problems with memory, attention and focus.
Participant characteristics   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants
Perimenopausal
4
  28.6%
Postmenopausal
10
  71.4%
Previous OCP use
11
  78.6%
Previous HT use
4
  28.6%
[1]
Measure Description: OCP: Oral contraceptive pill; HT: Hormonal therapy
1.Primary Outcome
Title Brown Attention Deficit Disorder Scale
Hide Description 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.
Time Frame Baseline and after 6 weeks intervention
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who completed both interventions.
Arm/Group Title Baseline Atomoxetine Placebo
Hide Arm/Group Description:
[Not Specified]
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: 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.
Overall Number of Participants Analyzed 12 12 12
Mean (Standard Deviation)
Unit of Measure: T score
organizing/activating 60.7  (11.6) 55.6  (8.9) 56.3  (8.9)
attention/concentration 58.8  (8.7) 52.1  (4.0) 56.4  (7.1)
alertness/effort/processing 57.4  (10.0) 54.2  (5.5) 54.7  (7.9)
managing affect interference 55.3  (7.9) 51.8  (4.5) 51.6  (3.8)
working memory/recall 61.3  (10.0) 52.4  (5.3) 59.6  (10.3)
2.Primary Outcome
Title BADDS Total Score
Hide Description The total BADDS ranged from 0-120 with higher scores meaning greater problems with memory, attention and focus.
Time Frame Baseline and after 6 weeks intervention
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who had at least one post randomization visit.
Arm/Group Title Baseline Atomoxetine Placebo
Hide Arm/Group Description:
[Not Specified]
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: 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.
Overall Number of Participants Analyzed 14 14 14
Mean (Standard Deviation)
Unit of Measure: units on a scale
38.6  (20.2) 25.5  (16.0) 30.1  (16.0)
3.Secondary Outcome
Title Blood Pressure
Hide Description [Not Specified]
Time Frame Baseline and after 6 weeks intervention
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who had least one post randomization visit.
Arm/Group Title Baseline Atomoxetine Placebo
Hide Arm/Group Description:
[Not Specified]
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: 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.
Overall Number of Participants Analyzed 14 14 14
Mean (Standard Deviation)
Unit of Measure: mm Hg
systolic BP 118.8  (12.5) 116.7  (11.3) 120.3  (8.5)
diastolic BP 74  (10.0) 69.8  (7.7) 70.7  (5.2)
4.Secondary Outcome
Title Heart Rate
Hide Description [Not Specified]
Time Frame Baseline and after 6 weeks intervention
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who had at least one post randomization visit.
Arm/Group Title Baseline Atomoxetine Placebo
Hide Arm/Group Description:
[Not Specified]
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: 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.
Overall Number of Participants Analyzed 14 14 14
Mean (Standard Deviation)
Unit of Measure: beats/min
63  (3.2) 68.8  (8.2) 66.3  (5.5)
5.Secondary Outcome
Title Weight
Hide Description [Not Specified]
Time Frame Baseline and after 6 weeks intervention
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who had at least one post randomization visit.
Arm/Group Title Baseline Atomoxetine Placebo
Hide Arm/Group Description:
[Not Specified]
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: 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.
Overall Number of Participants Analyzed 14 14 14
Mean (Standard Deviation)
Unit of Measure: lb
160.1  (41.8) 158.1  (44.4) 159.8  (42.6)
Time Frame Up to 16 weeks study intervention
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Atomoxetine Placebo
Hide Arm/Group Description 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: 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.
All-Cause Mortality
Atomoxetine Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Atomoxetine Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/16 (0.00%)   0/16 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Atomoxetine Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   2/16 (12.50%)   1/16 (6.25%) 
Cardiac disorders     
increase in blood pressure *  1/16 (6.25%)  0/16 (0.00%) 
racing heart *  0/16 (0.00%)  1/16 (6.25%) 
Gastrointestinal disorders     
Nausea *  2/16 (12.50%)  1/16 (6.25%) 
General disorders     
dry mouth *  0/16 (0.00%)  1/16 (6.25%) 
insomnia *  0/16 (0.00%)  1/16 (6.25%) 
Psychiatric disorders     
racing thoughts *  0/16 (0.00%)  1/16 (6.25%) 
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Cynthia Neill Epperson, M.D.
Organization: University of Pennsylvania
Phone: 215-573-8871
Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00611533     History of Changes
Other Study ID Numbers: 0403026533
First Submitted: January 29, 2008
First Posted: February 11, 2008
Results First Submitted: January 10, 2017
Results First Posted: March 3, 2017
Last Update Posted: April 17, 2017