Cognitive Impairments Clinical Trial
— LDXOfficial title:
LDX in the Treatment of Executive Function Difficulties in Women After Oophorectomy
Verified date | September 2017 |
Source | University of Pennsylvania |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is a double-blind, placebo-controlled, study testing whether LDX improves cognitive function and EF in 20 postmenopausal women who report onset of cognitive difficulties after oophorectomy (with or without subsequent chemo/adjunctive therapy). Brain imaging is included at critical time points to obtain objective data regarding effects of LDX as well as potential predictors of resilience in the face of oophorectomy.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | December 2013 |
Est. primary completion date | December 2013 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 30 Years to 60 Years |
Eligibility |
Inclusion Criteria: - Female; - Age 30-60; - Have undergone surgically-induced menopause by oophorectomy or chemically-induced menopause within the previous 10 years; - Have at least moderate executive functioning difficulties as evidenced by a score of 25 on the BADDS; - Have no history of a DSM-IV psychiatric disorder within the previous year or substance dependence disorder within the previous 5 years (psychostimulant abuse lifetime history), according to the Structured Clinical Interview for Diagnosis-DSM-IV (SCID)-Non-Patient Version; - Subject has history of substance abuse disorders (this includes alcohol, prescription, and illicit substances) 3 years ago but the period of abuse did not last more than 5 years according to the Structured Clinical Interview for DSM-IV Axis I Disorders (SCID-NP); - Are able to give written informed consent (obtained at screening visit); - Must have clear urine toxicology screen upon recruitment; - Are fluent in written and spoken English; - Are right-handed. Exclusion Criteria: - Mini-mental status exam score of 24; - Presence of a psychiatric disorder within previous year or a life time history of ADHD or psychotic disorder including bipolar disorder, schizoaffective disorder and schizophrenia; - Lifetime history of drug addiction or abuse, except nicotine; 4. Regular use of psychotropic medication except for a selective serotonin reuptake inhibitor or serotonin/norepinephrine reuptake inhibitor or standard sleep medication at a stable dose for at least one month prior to enrollment; - Regular use (more than once a week) of alcohol that is 3 drinks/day; - Presence of a contraindication to treatment with stimulant medication; this would include the presence of controlled or uncontrolled hypertension, coronary disease, atrial fibrillation, and arrhythmia; - History of seizures; - History of cardiac disease including known cardiac defect or conduction abnormality; - Abnormal electrocardiogram during screening; - Presence of a metallic implant; - Claustrophobia. |
Country | Name | City | State |
---|---|---|---|
United States | Penn Center for Women's Behavioral Wellness | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
University of Pennsylvania |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | BADDS Score | To determine whether treatment with LDX improves self-reported executive function (EF) as measured with the BADDS | 8-10 weeks | |
Secondary | Brain Activation | To determine the impact of LDX on brain activation in the brain during a working memory task. | 8-10 weeks |
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