LDX for the Treatment of Cognitive Functioning Issues in Women Post-Oophorectomy (LDX)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01986777|
Recruitment Status : Withdrawn (Funding not obtained)
First Posted : November 18, 2013
Last Update Posted : September 18, 2017
|Condition or disease||Intervention/treatment||Phase|
|Cognitive Impairments RRSO||Drug: lisdexamfetamine Drug: Placebo||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||LDX in the Treatment of Executive Function Difficulties in Women After Oophorectomy|
|Study Start Date :||July 2013|
|Actual Primary Completion Date :||December 2013|
|Actual Study Completion Date :||December 2013|
Active Comparator: lisdexamfetamine
Participants will have a 50% chance of receiving the active study medication. They will begin at 20 mg/d and will increase up to 60 mg/d after 4 weeks, if well tolerated. Total time on the study drug is up to 10 weeks.
Other Name: Vyvanse
Placebo Comparator: Placebo
Participants will have a 50% chance of receiving the placebo for this study. They will begin with 1 sugar pill and will increase up to 3 pills after 4 weeks. Maximum time for taking the placebo is 8-10 weeks.
The placebo capsules will be filled with lactose.
- BADDS Score [ Time Frame: 8-10 weeks ]To determine whether treatment with LDX improves self-reported executive function (EF) as measured with the BADDS
- Brain Activation [ Time Frame: 8-10 weeks ]To determine the impact of LDX on brain activation in the brain during a working memory task.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01986777
|United States, Pennsylvania|
|Penn Center for Women's Behavioral Wellness|
|Philadelphia, Pennsylvania, United States, 19104|
|Principal Investigator:||C. Neill Epperson, MD||University of Pennsylvania|