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

NCT01986777 | Withdrawn

• 1 other identifier: 817628
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Cognitive Impairments; RRSO

Keywords

cognitive complains; RRSO; oophorectomy; memory; cognition; early menopause

Outcome Measures

Primary Outcomes (1)

• BADDS Score

  To determine whether treatment with LDX improves self-reported executive function (EF) as measured with the BADDS

  8-10 weeks

Secondary Outcomes (1)

• Brain Activation

  8-10 weeks

Study Arms (2)

lisdexamfetamine

ACTIVE COMPARATOR

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

Placebo

PLACEBO COMPARATOR

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

Interventions

lisdexamfetamine DRUG

Also known as: Vyvanse

lisdexamfetamine

Placebo DRUG

The placebo capsules will be filled with lactose.

Placebo

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

Penn Center for Women's Behavioral Wellness

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Cognitive Dysfunction; Primary Ovarian Insufficiency

Interventions

Lisdexamfetamine Dimesylate

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Dextroamphetamine; Amphetamine; Amphetamines; Phenethylamines; Ethylamines; Amines; Organic Chemicals

Study Officials

• C. Neill Epperson, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2013
• First Posted: November 18, 2013
• Study Start: July 1, 2013
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: September 18, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)