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

This study has been completed.
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT00611533
First received: January 29, 2008
Last updated: March 20, 2017
Last verified: March 2017
Results First Received: January 10, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Participant, Investigator, Outcomes Assessor;   Primary Purpose: Treatment
Conditions: Menopause
Cognitive Disturbances
Interventions: Drug: atomoxetine
Drug: placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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.

Participant Flow for 2 periods

Period 1:   First Intervention (6 Weeks)
    Atomoxetine Then Placebo   Placebo Then Atomoxetine
STARTED   8   8 
COMPLETED   8   6 
NOT COMPLETED   0   2 
Never started study                0                1 
Adverse Event                0                1 

Period 2:   Second Intervention (6 Weeks)
    Atomoxetine Then Placebo   Placebo Then Atomoxetine
STARTED   8   6 
COMPLETED   8   4 
NOT COMPLETED   0   2 
Adverse Event                0                2 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants who had at least one post randomization visit.

Reporting Groups
  Description
All Study 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.

Baseline Measures
   All Study Participants 
Overall Participants Analyzed 
[Units: Participants]
 14 
Age 
[Units: Years]
Mean (Standard Deviation)
 54.0  (2.8) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      14 100.0% 
Male      0   0.0% 
Region of Enrollment 
[Units: Participants]
Count of Participants
 
United States   14 
Years of education 
[Units: Years]
Mean (Standard Deviation)
 16.4  (3.2) 
Months since last menstrual period 
[Units: Months]
Mean (Standard Deviation)
 29.3  (20.5) 
Follicle stimulating hormone 
[Units: IU/L]
Mean (Standard Deviation)
 76.0  (33.8) 
Estradiol 
[Units: pg/mL]
Mean (Standard Deviation)
 31.9  (32.9) 
Brown attention deficit disorder scale [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 38.6  (20.2) 
[1] The total BADDS ranged from 0-120, with higher scores meaning greater problems with memory, attention and focus.
Participant characteristics [1] 
[Units: Participants]
Count of Participants
 
Perimenopausal   4 
Postmenopausal   10 
Previous OCP use   11 
Previous HT use   4 
[1] OCP: Oral contraceptive pill; HT: Hormonal therapy


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Brown Attention Deficit Disorder Scale   [ Time Frame: Baseline and after 6 weeks intervention ]

2.  Primary:   BADDS Total Score   [ Time Frame: Baseline and after 6 weeks intervention ]

3.  Secondary:   Blood Pressure   [ Time Frame: Baseline and after 6 weeks intervention ]

4.  Secondary:   Heart Rate   [ Time Frame: Baseline and after 6 weeks intervention ]

5.  Secondary:   Weight   [ Time Frame: Baseline and after 6 weeks intervention ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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
e-mail: cepp@mail.med.upenn.edu


Publications:

Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00611533     History of Changes
Other Study ID Numbers: 0403026533
Study First Received: January 29, 2008
Results First Received: January 10, 2017
Last Updated: March 20, 2017