MenopausePhase 4NCT01977625

LDX and Functional Magnetic Resonance Imaging (fMRI in Menopausal Women

A Phase 4 study testing Lisdexamfetamine in people with Menopause and Brain Activity, 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: Menopause, Brain Activity, Cognition
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: 18 participants
Where: 1 siteUnited States
Study dates: Dec 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

Have no previous or present history of a DSM-IV psychiatric or substance dependence disorder within the previous year, according to the Structured Clinical Interview for Diagnosis- DSM-IV (SCID)-Non-Patient Version;
Are within 5 years of last menstrual period (LMP);
Have a follicular stimulating hormone level (FSH) of 20 IU/ml;
Are able to give written informed consent;
Must have clear urine toxicology screen upon recruitment;
Are fluent in written and spoken English;
Are right-handed;
Negative urine pregnancy test if still menstruating.

Who cannot join

Mini-mental status exam score of less than or equal to 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;
Regular use of other psychotropic medication;
Regular use (more than once a week) of alcohol that is less than 3 drinks/day;
Presence of a contraindication to treatment with stimulant medication unless the condition is controlled with medication; this would include the presence of uncontrolled hypertension, coronary disease, atrial fibrillation, and arrhythmia;

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History of seizures;
History of cardiac disease including known cardiac defect or conduction abnormality;
Abnormal electrocardiogram during screening;
Use of estrogen therapy within previous 2 months;
Current pregnancy or planning to become pregnant;
Metallic implant;
Claustrophobia.

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Pennsylvania, Penn Center for Womens Behavioral Wellness
Philadelphia, Pennsylvania, 19104

Other trials in United States

About this study

Official title: Utilizing fMRI to Determine the Effects of Vyvanse® on Memory, Attention, and Brain Activity in Menopausal Women

This study seeks to assess the effects of lisdexamfetamine (trademark name: Vyvanse; LDX) on executive function and prefrontal cortex activation in menopausal women ages 45-57, who report subjective cognitive difficulties. This protocol will recruit women from Dr. Epperson's ongoing study, Protocol #812470, to examine the impact of LDX on brain activation during performance of cognitive tasks specifically probing prefrontal cortex function.

Conditions: Menopause, Brain Activity, Cognition
Being tested: Lisdexamfetamine, Placebo
Keywords: Menopause, fMRI, Vyvanse

What participants receive

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

LisdexamfetamineDrug
Also called Vyvanse®
The overall objective of this study is to assess the effects of LDX on brain activation patterns during tasks of sustained attention and working memory in menopausal women.
PlaceboOther
Also called Sugar pill
To assess the effects of a placebo pill on brain activation patterns during tasks of sustained attention and working memory in menopausal women.

Study groups in NCT01977625
Study group	Role	What they receive
Lisdexamfetamine	Active comparator	Lisdexamfetamine or Vyvanse Receives: Drug: Lisdexamfetamine
Sugar Pill	Placebo comparator	Placebo pill, capsules Receives: Other: Placebo

What is being measured

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

Percent Change in Blood Oxygen Level Dependent (BOLD) Signal
Blood-oxygen-level dependent contrast imaging, or BOLD-contrast imaging, is a method used in functional magnetic resonance imaging (fMRI) to observe different areas of the brain or other organs, which are found to be active at any given time. BOLD signals were compared from baseline, first intervention and second intervention.
Measured: 10 weeks

Secondary outcomes (1)

Change in BADDS Total Score
The total BADDS ranged from 0-120 with higher scores meaning greater problems with memory, attention and focus. Difference in BADDS score from Baseline to End of Treatment for each study Arm was calculated.
Measured: 10 weeks

Timeline

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

Dec 2011Apr 2014

First posted6 Nov 2013 (estimated)
Study startDec 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 (3)Papers the sponsor has linked to this study.
Other trials for 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: Double blind
Who is masked: Participant, Investigator
Enrolment: 18 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01977625
Sponsor's protocol ID: 814735
Status last verified: Jul 2017
First submitted: 30 Oct 2013
Last updated: 27 Jul 2018
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
Shanmugan S, Loughead J, Nanga RP, Elliott M, Hariharan H, Appleby D, Kim D, Ruparel K, Reddy R, Brown TE, Epperson CN. Lisdexamfetamine Effects on Executive Activation and Neurochemistry in Menopausal Women with Executive Function Difficulties. Neuropsychopharmacology. 2017 Jan;42(2):437-445. doi: 10.1038/npp.2016.162. Epub 2016 Aug 23.
PubMed 27550732

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 27 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Utilizing fMRI to Determine the Effects of Vyvanse® on Memory, Attention, and Brain Activity in Menopausal Women
ClinicalTrials.gov ID: NCT01977625
Acronym / sponsor ID: 814735
Conditions: Menopause, Brain Activity, Cognition
Keywords: Menopause, fMRI, Vyvanse
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 18 participants (actual)
Lead sponsor: University of PennsylvaniaUniversity, hospital or other
Collaborators: Shire
Study start: Dec 2011
Primary completion: Apr 2014 (actual)
Study completion: Apr 2014 (actual)
First posted: 6 Nov 2013 (estimated)
Results: Posted 11 Jul 2017

Clinical summary

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

Study design

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

Arm	Type	Receives
Lisdexamfetamine	Active comparator	Drug: LisdexamfetamineLisdexamfetamine or Vyvanse
Sugar Pill	Placebo comparator	Other: PlaceboPlacebo pill, capsules

Who may qualify

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

Key inclusion criteria (8 listed)

Have no previous or present history of a DSM-IV psychiatric or substance dependence disorder within the previous year, according to the Structured Clinical Interview for Diagnosis- DSM-IV (SCID)-Non-Patient Version;
Are within 5 years of last menstrual period (LMP);
Have a follicular stimulating hormone level (FSH) of 20 IU/ml;
Are able to give written informed consent;
Must have clear urine toxicology screen upon recruitment;

Key exclusion criteria (13 listed)

Mini-mental status exam score of less than or equal to 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;
Regular use of other psychotropic medication;
Regular use (more than once a week) of alcohol that is less than 3 drinks/day;

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®The overall objective of this study is to assess the effects of LDX on brain activation patterns during tasks of sustained attention and working memory in menopausal women.	Drug	Lisdexamfetamine
PlaceboAlso: Sugar pillTo assess the effects of a placebo pill on brain activation patterns during tasks of sustained attention and working memory in menopausal women.	Other	Sugar Pill

Primary outcome

Percent Change in Blood Oxygen Level Dependent (BOLD) Signal
Time frame: 10 weeks
Blood-oxygen-level dependent contrast imaging, or BOLD-contrast imaging, is a method used in functional magnetic resonance imaging (fMRI) to observe different areas of the brain or other organs, which are found to be active at any given time. BOLD signals were compared from baseline, first intervention and second intervention.

1 secondary outcome

Change in BADDS Total Score
Time frame: 10 weeks

Results and safety

Results posted to the registry on 11 Jul 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	11	8
Placebo, Then Lisdexamfetamine	7	7

Primary outcome: Percent Change in Blood Oxygen Level Dependent (BOLD) Signal

Time frame: 10 weeks. Mean (Standard Deviation). Unit: percent change

Measure	Lisdexamfetamine n = 14	Placebo n = 14
Value	0.41 (0.65)	-0.11 (0.46)

Population analysed: All participants who completed all phases of the study were included in the outcome analysis.

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Lisdexamfetamine	0 of 15 (0%)	1 of 15 (6.7%)	Not reported
Placebo	0 of 15 (0%)	1 of 15 (6.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2018.
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.
Results publication: PubMed 27550732Shanmugan S, Loughead J, Nanga RP, Elliott M, Hariharan H, Appleby D, Kim D, Ruparel K, Reddy R, Brown TE, Epperson CN. Lisdexamfetamine Effects on Executive Activation and Neurochemistry in Menopausal Women with Executive Function Difficulties. Neuropsychopharmacology. 2017 Jan;42(2):437-445. doi: 10.1038/npp.2016.162. Epub 2016 Aug 23.
Individual participant dataSharing planned: No

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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.

Cynthia Neill Epperson, M.D. 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 Menopause and Brain Activity, 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 8 inclusion and 13 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 27 Jul 2018. 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.

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 11 Jul 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?

Percent Change in Blood Oxygen Level Dependent (BOLD) Signal (time frame: 10 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 NCT01977625, which also lists 3 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 27 Jul 2018.