Cognitive ImpairmentsLDXNCT01986777
LDX for the Treatment of Cognitive Functioning Issues in Women Post-Oophorectomy
A study testing lisdexamfetamine in people with Cognitive Impairments and RRSO, run by University of Pennsylvania at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 30 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cognitive Impairments, RRSO
- What is being tested?
- lisdexamfetamine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2013to Dec 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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);
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- 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.
Who cannot join
- 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;
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- History of cardiac disease including known cardiac defect or conduction abnormality;
- Abnormal electrocardiogram during screening;
- Presence of a metallic implant;
- Claustrophobia.
Trial locations and contacts
1 site in 1 country.
United States1 site
Penn Center for Women's Behavioral Wellness
Philadelphia, Pennsylvania, 19104
About this study
Official title: LDX in the Treatment of Executive Function Difficulties in Women After Oophorectomy
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.
Read the 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.
- Conditions
- Cognitive Impairments, RRSO
- Being tested
- lisdexamfetamine, Placebo
- Keywords
- cognitive complains, RRSO, oophorectomy, memory, cognition, early menopause
- Medical subject headings
- Cognitive Dysfunction, Primary Ovarian Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lisdexamfetamineDrug
Also called Vyvanse
PlaceboDrug
The placebo capsules will be filled with lactose.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
BADDS Score
To determine whether treatment with LDX improves self-reported executive function (EF) as measured with the BADDS
Measured: 8-10 weeks
Secondary outcomes (1)
Brain Activation
To determine the impact of LDX on brain activation in the brain during a working memory task.
Measured: 8-10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2013 (estimated)
- Study startJul 2013
- Primary completionDec 2013
- Study completionDec 2013
Why it stopped: Funding not obtained
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive ImpairmentsStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- C. Neill Epperson, MD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01986777
- Sponsor's protocol ID
- 817628
- Acronym
- LDX
- Status last verified
- Sep 2017
- First submitted
- 30 Oct 2013
- Last updated
- 18 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Study has been withdrawn
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LDX in the Treatment of Executive Function Difficulties in Women After Oophorectomy
- ClinicalTrials.gov ID
- NCT01986777
- Acronym / sponsor ID
- LDX / 817628
- Conditions
- Cognitive Impairments, RRSO
- Keywords
- cognitive complains, RRSO, oophorectomy, memory, cognition, early menopause
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Funding not obtained
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 18 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| lisdexamfetamine | Active comparator | Drug: lisdexamfetamineParticipants 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. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants 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. |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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;
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| lisdexamfetamineAlso: Vyvanse | Drug | lisdexamfetamine |
| PlaceboThe placebo capsules will be filled with lactose. | Drug | Placebo |
Primary outcome
BADDS Score
Time frame: 8-10 weeks
To determine whether treatment with LDX improves self-reported executive function (EF) as measured with the BADDS
1 secondary outcome
Brain Activation
Time frame: 8-10 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2017.
- Individual participant dataSharing planned: No. Study has been withdrawn
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
C. Neill Epperson, MD principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing lisdexamfetamine in people with Cognitive Impairments and RRSO, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 18 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BADDS Score (time frame: 8-10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2017.