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DementiaPhase 3S-CitADNCT03108846

Escitalopram for Agitation in Alzheimer's Disease

A Phase 3 study testing Escitalopram in people with Dementia, run by JHSPH Center for Clinical Trials at 29 sites in 2 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The purpose of this study is to evaluate the safety and efficacy of escitalopram for agitation in Alzheimer's dementia. Read more about this study

Who is it for?
Ages 18 to 109 years
Conditions the study is for
Dementia
What is being tested?
Escitalopram
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
187 participants
Where
29 sitesin 2 countries
Study dates
3 Jan 2018to May 2025
Phase
Phase 3
Are there results?
Not yet: the study is under way

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 18 to 109 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Alzheimer's dementia diagnosed clinically by the National Institute on Aging (NIA) and the Alzheimer's Association (AA) (2011 NIA/AA criteria)
  • Mini-Mental State Examination Telephone (MMSET) score of 3-20 inclusive
  • Meets the International Psychogeriatric Association (IPA) provisional criteria for agitation in cognitive disorders
  • Clinically significant agitation/aggression as assessed by the Neuropsychiatric Inventory (NPI) for which either:
  • The frequency is 'Very frequently,' or
  • The frequency is 'Frequently' AND the severity is 'Moderate' or 'Marked'
Show all 10Show fewer
  • Provision of informed consent for participation in the study by both caregiver and participant (or, if participant is unable to provide informed consent, with surrogate consent and participant assent)
  • Availability of a caregiver who spends at least several hours per week with the participant, supervises his/her care, is willing to accompany the participant to study visits, and is willing to participate in the study
  • Stable (for ≥ 7 days) dosing of antipsychotics for agitation or psychosis, if being used at all
  • A medication for agitation is appropriate, in the opinion of the study physician

Who cannot join

  • Has major depression, as indicated by major depressive episode (MDE) in the past 90 days (meeting the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-V) criteria)
  • Presence of another brain disease that fully explains the dementia, (e.g., extensive brain vascular disease, Parkinson's disease, dementia with Lewy bodies, traumatic brain injury, or multiple sclerosis)
  • Residence in a skilled nursing or Long-Term Acute Care (LTAC) facility
  • Contraindication to treatment with escitalopram as determined by a study physician, such as recent (30 days) use of monoamine oxidase inhibitors (MAOIs) or potential participant is hypersensitive to escitalopram or citalopram or any inactive ingredients
  • Prior failed treatment attempt with citalopram or escitalopram for agitation after adequate trial, at minimally accepted dose
  • Indication for psychiatric hospitalization or acute suicidality, in the opinion of the study physician
Show all 19Show fewer
  • Recent (< 7 days) changes in antipsychotics, anticonvulsants, or psychosis (delusions or hallucinations) requiring a new or change in antipsychotic treatment (in the opinion of the study physician)
  • Abnormal corrected QT interval using Bazett's formula (QTcB)** as determined on enrollment ECG (defined as > 450 ms for men and > 470 ms for women)
  • Recent (30 days) presence of severely reduced renal function (as identified by a Glomerular filtration rate (GFR) clearance < 30 mL/min) or reduced hepatic function
  • Current treatment (within 7 days) with any of the following:
  • antidepressants (other than trazodone, ≤ 100 mg per day at bedtime)
  • benzodiazepines (other than lorazepam), or
  • psychostimulants
  • Recent (< 14 days) changes in Dextromethorphan/quinidine, prazosin, and pimavanserin
  • Recent (< 14 days) use of medical marijuana
  • Current participation in a clinical trial or in any study that may add a significant burden or affect neuropsychological or other study outcomes
  • Significant communicative impairments that would affect participation in a clinical trial
  • Any condition that, in the opinion of the study physician, makes it medically inappropriate or risky for the potential participant to enroll in the trial
  • if the QTcB is determined while the rhythm is paced, 50 ms is subtracted from the calculated value. The study cardiologist must confirm eligibility in this scenario.

Trial locations and contacts

29 sites in 2 countries.

29 sites in 2 countries

United States22 sites

  • Abington Neurological Associates, Ltd

    Abington, Pennsylvania, 19001

  • Maryland VA Health Care System

    Baltimore, Maryland, 21202

  • Johns Hopkins University School of Medicine, Bayview Medical Center

    Baltimore, Maryland, 21224

  • Northwest Clinical Research Center

    Bellevue, Washington, 98007

  • Roper St. Francis Healthcare

    Charleston, South Carolina, 29401

  • University of Virginia Adult Neurology

    Charlottesville, Virginia, 22903

  • Ohio State University

    Columbus, Ohio, 43221

  • Baylor AT&T Memory Center

    Dallas, Texas, 75231

  • Hackensack Meridian Health

    Hackensack, New Jersey, 07601

  • Biomedical Research Foundation

    Little Rock, Arkansas, 72205

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205

  • University of California Los Angeles/VA Greater Los Angeles Healthcare System

    Los Angeles, California, 90073

  • University of Southern California Keck School of Medicine Memory and Aging Center

    Los Angeles, California, 90089

  • Miami Jewish Health Systems

    Miami, Florida, 33137

  • Columbia University

    New York, New York, 10032

  • Eastern Virginia Medical School

    Norfolk, Virginia, 23510

  • Alzheimer Disease Research Center; University of Pittsburgh

    Pittsburgh, Pennsylvania, 15213

  • Alzheimer Disease Center

    Quincy, Massachusetts, 02169

  • University of Rochester Medical Center

    Rochester, New York, 14620

  • UT Health San Antonio

    San Antonio, Texas, 78229

  • Banner Sun Health Research Institute

    Sun City, Arizona, 85351

  • Kansas School of Medicine-Wichita Center for Clinical Research

    Wichita, Kansas, 67214

Other trials in United States

Canada7 sites

  • University of Calgary and Foothills Medical Centre

    Calgary, Alberta

  • Lawson Health Research Institute/Parkwood Institute

    London, Ontario, N6C 0A7

  • Neuropsychopharmacology Research Group, Sunnybrook

    Toronto, Ontario, M4N 3M5

  • Unity Health

    Toronto, Ontario, M5B 1W8

  • Centre for Addiction and Mental Health

    Toronto, Ontario, M6J1H4

  • Centre for Memory and Aging

    Toronto, Ontario

  • Ontario Shores

    Whitby, Ontario, L1N 5S9

Other trials in Canada

About this study

The purpose of this study is to evaluate the safety and efficacy of escitalopram for agitation in Alzheimer's dementia.

Read the detailed description

This study is designed to examine the efficacy and safety of escitalopram as treatment for agitation in Alzheimer's dementia (AD) patients. Participants with clinically significant agitation, and their caregiver(s), will receive a structured psychosocial intervention. Participants not showing a response three weeks later will be randomized 1:1 to escitalopram (up to 15 mg/day) or a matching placebo. Participants will receive study drug or placebo for 12 weeks, with in-person and remote (phone/video) visits at weeks 3, 6, 9, and 12, and with telephone contacts between in-person and remote visits. Participants who do show a response to the psychosocial intervention will not be randomized to study drug but will be followed remotely.

Conditions
Dementia
Being tested
Escitalopram, Placebo
Keywords
Alzheimer's Disease, Agitation
Medical subject headings
Dementia, Alzheimer Disease, Psychomotor Agitation

What participants receive

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

  • EscitalopramDrug

    Also called Lexapro

    5-15 mg/day (target: 15mg/day if tolerated)

  • PlaceboDrug

    Also called non-applicable

    Masked placebo

Study groups in NCT03108846
Study groupRoleWhat they receive
EscitalopramExperimentalEscitalopram up to 15mg/day taken as 1-3 capsules each containing 5mg escitalopram once per day in the morning
Receives: Drug: Escitalopram
PlaceboPlacebo comparator1-3 capsules each containing placebo only once per day in the morning
Receives: Drug: Placebo

What is being measured

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

  1. modified- Alzheimer's Disease Cooperative Study--Clinical Global Impression of Change (mADCS-CGIC)

    Clinical Global Impression of Change

    Measured: after 12 weeks

Timeline

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

  1. First posted11 Apr 2017
  2. Study start3 Jan 2018
  3. Primary completion5 Apr 2024
  4. Study completionMay 2025 (estimated)

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
187 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03108846
Sponsor's protocol ID
S-CitAD
Other IDs
R01AG052510
Acronym
S-CitAD
Status last verified
Jan 2025
First submitted
6 Apr 2017
Last updated
31 Jan 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Rajji TK, Baksh SN, Shade DM, Ismail Z, Burhan AM, Okhravi HR, Padala PR, Rosenberg PB, Schneider LS, Porsteinsson AP, Lyketsos CG; S-CitAD Research Group. Escitalopram for agitation in Alzheimer's dementia: a randomized controlled phase 3 trial. Nat Med. 2025 May;31(5):1586-1591. doi: 10.1038/s41591-025-03569-y. Epub 2025 Mar 25.

    PubMed 40133524

  • Ehrhardt S, Porsteinsson AP, Munro CA, Rosenberg PB, Pollock BG, Devanand DP, Mintzer J, Rajji TK, Ismail Z, Schneider LS, Baksh SN, Drye LT, Avramopoulos D, Shade DM, Lyketsos CG; S-CitAD Research Group. Escitalopram for agitation in Alzheimer's disease (S-CitAD): Methods and design of an investigator-initiated, randomized, controlled, multicenter clinical trial. Alzheimers Dement. 2019 Nov;15(11):1427-1436. doi: 10.1016/j.jalz.2019.06.4946. Epub 2019 Oct 3.

    PubMed 31587995

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Escitalopram in people with Dementia, run by JHSPH Center for Clinical Trials at 29 sites in 2 countries.

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 19 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: under way, not looking for participants, as of the sponsor's last update on 31 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 29 sites in United States, Canada. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

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?

modified- Alzheimer's Disease Cooperative Study--Clinical Global Impression of Change (mADCS-CGIC) (time frame: after 12 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 NCT03108846, 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 31 Jan 2025.

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