Symptomatic MenopausePhase 4NCT01324024

Attention & Memory Impairments in Menopausal Women

A Phase 4 study testing Lisdexamfetamine in people with Symptomatic Menopause and Cognitive Impairments, run by University of Pennsylvania at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 45 to 60 years, women onlyHealthy volunteers can take part
Conditions the study is for: Symptomatic Menopause, Cognitive Impairments
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: 35 participants
Where: 1 siteUnited States
Study dates: May 2011to Apr 2014
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 45 to 60 years
Women only
Healthy volunteers accepted
Adult

Who may be able to join

Women ages 45 to 60 will be eligible for this study if they:
Are within 5 years of their last menstrual period;
Are able to give written informed consent;
Must have clear urine toxicology screen upon recruitment;
Are fluent in written and spoken English;
Must have negative urine pregnancy test if still menstruating.

Who cannot join

History of seizures;
History of cardiac disease including known cardiac defect or conduction abnormality;
Abnormal electrocardiogram during screening;
Use of estrogen therapy within previous 6 months;
Current pregnancy or planning to become pregnant.
Presence of a contraindication to treatment with stimulant medication; this would include the presence of hypertension, coronary disease, atrial fibrillation, and arrhythmia.

Trial locations and contacts

1 site in 1 country.

United States1 site

Penn Center for Women's Behavioral Wellness
Philadelphia, Pennsylvania, 19104

Other trials in United States

About this study

Official title: Attention & Memory Impairments in Menopausal Women: A Possible Role for Vyvanse?

The purpose of this study is to determine whether a medication called Vyvanse® (lisdexamfetamine; LDX) has an impact on cognitive functioning, specifically measures of sustained attention, verbal encoding and recall and working memory, in menopausal aged women. LDX is a medication used to treat attention deficit hyperactivity disorder (ADHD). The cognitive difficulties that menopausal women report experiencing are typical of adults who are diagnosed with ADHD. The investigators will assess whether or not LDX is effective in alleviating those cognitive disruptions when compared to a placebo.

Read the detailed description

Midlife decline in cognitive function, particularly attention and working memory, is a frequent complaint for which menopausal women seek clinical intervention. Many of the cognitive complaints detected in menopausal women including, short-term memory, organization of tasks, sustaining focus and concentration, and regulating emotions, overlap with symptoms frequently reported by adults with ADHD. These impairments are reported by many women who have no previous history of ADHD, and appear to be linked to reduced estrogen levels occurring in menopause.

This is a double-blind, placebo-controlled, cross-over study testing whether LDX, a stimulant medication, would be effective in alleviating midlife onset impairments of attention and working memory among menopausal women. There will be 3 days in which subjects will undergo a brief cognitive testing assessment; the first testing period will occur at baseline prior to beginning LDX or placebo treatment (PT) in trial A; the second testing period will occur following 4 weeks of double blind LDX or PT; and the final testing period will take place after another 4 weeks of double blind LDX or PT in Trial B. Each cognitive test period will involve 2 separate cognitive testing batteries that will take approximately 120 minutes total to complete.

Conditions: Symptomatic Menopause, Cognitive Impairments
Being tested: Lisdexamfetamine, Placebo
Keywords: Menopause, Aging, Memory, Women
Medical subject headings: Cognitive Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

LisdexamfetamineDrug
Also called Vyvanse®
In a counterbalanced fashion, participants would receive titrated doses of LDX 20 to 60 mg/d for 4 weeks followed by a 2-week washout and then crossed over to the placebo tablets for another 4 weeks. All women will start with LDX 20 mg/d and then be titrated to 40 mg/d after 1 week and 60 mg/d after 2 weeks (as tolerated).
PlaceboDrug
In a counterbalanced fashion, participants would receive placebo tablets for 4 weeks followed by a 2 week washout, then will receive titrated doses of LDX 20 to 60 mg/d for 4 weeks.

Study groups in NCT01324024
Study group	Role	What they receive
Lisdexamfetamine, then placebo	Experimental	Participants first received titrated doses of Lisdexamfetamine 20 to 60 mg/d each day for 4 weeks followed by a 2-week washout, then they received Placebo tablets (matching Lisdexamfetamine tablets) each day for 4 weeks. Receives: Drug: Lisdexamfetamine; Drug: Placebo
Placebo, then Lisdexamfetamine	Experimental	Participants first received Placebo tablets (matching Lisdexamfetamine tablets) each day for 4 weeks followed by a 2-week washout, then they received titrated doses of Lisdexamfetamine 20 to 60 mg/d each day for 4 weeks. Receives: Drug: Lisdexamfetamine; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Brown Attention Deficit Disorder Scale (BADDS)
The BADDS questionnaire is a clinician administered questionnaire that assesses the frequency and severity of five clusters of symptoms reflective of executive dysfunction reported by individuals with ADHD. Participants are asked to rate the frequency and severity of a symptom on a scale from 0 to 3, with 0 meaning that the problem described does not relate to them and 3 indicating that the problem is very true for them and occurs almost daily. The range of severity for the total BADDS score is 0 to 120, with scores of 55 and above being consistent with full-syndrome ADHD.
Measured: Baseline, end of first Intervention (4 weeks) and end of second Intervention (4 weeks)

Secondary outcomes (2)

Penn Continuous Performance Test
The Penn Continuous Performance Test is a measure of visual attention and vigilance. In this task, a series of red vertical and horizontal lines flash in a digital numeric frame. The participant must press the spacebar whenever the lines form complete numbers or complete letters. The minimum to maximum score range for this task is 0-60 correct responses, with 60 being a perfect score. This data presented in the outcome measure table reflects the total number of correct responses.
Measured: Baseline, end of first Intervention (4 weeks) and end of second Intervention (4 weeks)
NYU Paragraph Recall Task
Subjects hear 2 brief narratives, each containing 19-21 informational bits, and are asked to recall as many details as possible immediately after hearing each paragraph (A and B) and again following a 30 minute delay. Subjects receive credit for each informational bit recalled verbatim. Different paragraphs were read at each assessment. The maximum number of correct responses for paragraph A is 19 and the maximum number of correct responses for paragraph B is 21.
Measured: Baseline, end of first Intervention (4 weeks) and end of second Intervention (4 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2011Apr 2014

First posted28 Mar 2011 (estimated)
Study startMay 2011
Primary completionApr 2014
Study completionApr 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Symptomatic MenopauseStudies 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 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 35 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01324024
Sponsor's protocol ID: 812470
Status last verified: May 2017
First submitted: 24 Mar 2011
Last updated: 28 Jun 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Publications

Epperson CN, Pittman B, Czarkowski KA, Bradley J, Quinlan DM, Brown TE. Impact of atomoxetine on subjective attention and memory difficulties in perimenopausal and postmenopausal women. Menopause. 2011 May;18(5):542-8. doi: 10.1097/gme.0b013e3181fcafd6.
PubMed 21293309
Epperson CN, Shanmugan S, Kim DR, Mathews S, Czarkowski KA, Bradley J, Appleby DH, Iannelli C, Sammel MD, Brown TE. New onset executive function difficulties at menopause: a possible role for lisdexamfetamine. Psychopharmacology (Berl). 2015 Aug;232(16):3091-100. doi: 10.1007/s00213-015-3953-7. Epub 2015 Jun 11.
PubMed 26063677

Study at a glance

From the registry record, last updated by the sponsor on 28 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Attention & Memory Impairments in Menopausal Women: A Possible Role for Vyvanse?
ClinicalTrials.gov ID: NCT01324024
Acronym / sponsor ID: 812470
Conditions: Symptomatic Menopause, Cognitive Impairments
Keywords: Menopause, Aging, Memory, Women
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 35 participants (actual)
Lead sponsor: University of PennsylvaniaUniversity, hospital or other
Collaborators: Shire
Study start: May 2011
Primary completion: Apr 2014 (actual)
Study completion: Apr 2014 (actual)
First posted: 28 Mar 2011 (estimated)
Results: Posted 28 Jun 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Lisdexamfetamine, then placebo	Experimental	Drug: Lisdexamfetamine, Drug: PlaceboParticipants first received titrated doses of Lisdexamfetamine 20 to 60 mg/d each day for 4 weeks followed by a 2-week washout, then they received Placebo tablets (matching Lisdexamfetamine tablets) each day for 4 weeks.
Placebo, then Lisdexamfetamine	Experimental	Drug: Lisdexamfetamine, Drug: PlaceboParticipants first received Placebo tablets (matching Lisdexamfetamine tablets) each day for 4 weeks followed by a 2-week washout, then they received titrated doses of Lisdexamfetamine 20 to 60 mg/d each day for 4 weeks.

Who may qualify

Ages: 45 to 60 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (6 listed)

Are within 5 years of their last menstrual period;
Are able to give written informed consent;
Must have clear urine toxicology screen upon recruitment;
Are fluent in written and spoken English;
Must have negative urine pregnancy test if still menstruating.

Key exclusion criteria (6 listed)

History of seizures;
History of cardiac disease including known cardiac defect or conduction abnormality;
Abnormal electrocardiogram during screening;
Use of estrogen therapy within previous 6 months;
Current pregnancy or planning to become pregnant.

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®In a counterbalanced fashion, participants would receive titrated doses of LDX 20 to 60 mg/d for 4 weeks followed by a 2-week washout and then crossed over to the placebo tablets for another 4 weeks. All women will start with LDX 20 mg/d and then be titrated to 40 mg/d after 1 week and 60 mg/d after 2 weeks (as tolerated).	Drug	Lisdexamfetamine, then placebo, Placebo, then Lisdexamfetamine
PlaceboIn a counterbalanced fashion, participants would receive placebo tablets for 4 weeks followed by a 2 week washout, then will receive titrated doses of LDX 20 to 60 mg/d for 4 weeks.	Drug	Lisdexamfetamine, then placebo, Placebo, then Lisdexamfetamine

Primary outcome

Brown Attention Deficit Disorder Scale (BADDS)
Time frame: Baseline, end of first Intervention (4 weeks) and end of second Intervention (4 weeks)
The BADDS questionnaire is a clinician administered questionnaire that assesses the frequency and severity of five clusters of symptoms reflective of executive dysfunction reported by individuals with ADHD. Participants are asked to rate the frequency and severity of a symptom on a scale from 0 to 3, with 0 meaning that the problem described does not relate to them and 3 indicating that the problem is very true for them and occurs almost daily. The range of severity for the total BADDS score is 0 to 120, with scores of 55 and above being consistent with full-syndrome ADHD.

2 secondary outcomes

Penn Continuous Performance Test
Time frame: Baseline, end of first Intervention (4 weeks) and end of second Intervention (4 weeks)
NYU Paragraph Recall Task
Time frame: Baseline, end of first Intervention (4 weeks) and end of second Intervention (4 weeks)

Results and safety

Results posted to the registry on 28 Jun 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Lisdexamfetamine, Then Placebo	18	18
Placebo First, Then Lisdexamfetamine	17	17

Primary outcome: Brown Attention Deficit Disorder Scale (BADDS)

Time frame: Baseline, end of first Intervention (4 weeks) and end of second Intervention (4 weeks). Mean (Standard Deviation). Unit: units on a scale

Measure	Baseline n = 35	Lisdexamfetamine n = 32	Sugar Pill n = 32
Value	35.7 (16.8)	21.2 (16.8)	29.8 (17.7)

Population analysed: Of the 55 participants who were consented for screening, 20 were excluded. Of the remaining 35 subjects, 32 completed both active and placebo treatment trials. The numbers in the lisdexamphetamine and placebo arms reflect the fact that 32 subjects completed both arms. 35 total participant data was analyzed for the baseline arm.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: From study start to study completion only. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Lisdexamfetamine	0 of 32 (0%)	6 of 32 (18.8%)	0 of 32
Sugar Pill	0 of 32 (0%)	1 of 32 (3.1%)	0 of 32

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 21293309Epperson CN, Pittman B, Czarkowski KA, Bradley J, Quinlan DM, Brown TE. Impact of atomoxetine on subjective attention and memory difficulties in perimenopausal and postmenopausal women. Menopause. 2011 May;18(5):542-8. doi: 10.1097/gme.0b013e3181fcafd6.
Results publication: PubMed 26063677Epperson CN, Shanmugan S, Kim DR, Mathews S, Czarkowski KA, Bradley J, Appleby DH, Iannelli C, Sammel MD, Brown TE. New onset executive function difficulties at menopause: a possible role for lisdexamfetamine. Psychopharmacology (Berl). 2015 Aug;232(16):3091-100. doi: 10.1007/s00213-015-3953-7. Epub 2015 Jun 11.
Click here for more information about our center.Link provided by the sponsor.
Individual participant dataSharing planned: No

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.

Cynthia N 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 Phase 4 study testing Lisdexamfetamine in people with Symptomatic Menopause and Cognitive Impairments, 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 6 inclusion and 6 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: finished, as of the sponsor's last update on 28 Jun 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Jun 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Brown Attention Deficit Disorder Scale (BADDS) (time frame: Baseline, end of first Intervention (4 weeks) and end of second Intervention (4 weeks)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01324024, which also lists 2 linked publications.

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 28 Jun 2017.