LDX for the Treatment of Cognitive Functioning Issues in Women Post-Oophorectomy

Sponsor

University of Pennsylvania (Other)

Overall Status

Withdrawn

CT.gov ID

NCT01986777

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Cognitive Impairments RRSO	Drug: lisdexamfetamine Drug: Placebo	N/A

Detailed Description

Participants will be asked to undergo three brain-imaging scans throughout the course of the study. Once they are deemed eligible for participation based on two assessment visits, they will be scheduled for their baseline test day. On this they, they will be asked to under a series of cognitive tests following by a brain-imaging scan. They will then take the first dose of either the LDX or placebo, wait for 3 hours and then undergo another brain-imaging scan to assess acute changes to memory/cognition due to the study drug. They will then come in for three 30-minute check-in visits during weeks 2, 4 and 6 on the study drug. They will be asked to undergo a final scan and series of cognitive tasks during weeks 8-10 on the study drug. They will then be discharged from active study participation. All participants, regardless of randomization, will be offered a consultation with the study MD and optional prescription for 4-weeks of treatment with LDX.

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

LDX in the Treatment of Executive Function Difficulties in Women After Oophorectomy

Study Start Date :

Jul 1, 2013

Actual Primary Completion Date :

Dec 1, 2013

Actual Study Completion Date :

Dec 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
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.	Drug: lisdexamfetamine Other Names: 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.	Drug: Placebo The placebo capsules will be filled with lactose.

Arm

Intervention/Treatment

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.

Drug: lisdexamfetamine

Other Names:

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.

Drug: Placebo

The placebo capsules will be filled with lactose.

Outcome Measures

Primary Outcome Measures

BADDS Score [8-10 weeks]
To determine whether treatment with LDX improves self-reported executive function (EF) as measured with the BADDS

Secondary Outcome Measures

Brain Activation [8-10 weeks]
To determine the impact of LDX on brain activation in the brain during a working memory task.

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 60 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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.