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Find more clinical trials

Escitalopram for Agitation in Alzheimer's Disease

Start: January 3, 2018
End: May 2025
Enrollment: 392

What Is This Study About?

Escitalopram (Lexapro) is a drug approved by the U.S. Food and Drug Administration for the treatment of depression and generalized anxiety disorder. This study will evaluate its safety and efficacy to treat agitation in Alzheimer's disease. Participants will be randomly assigned to take up to 15 mg per day of the study drug or a placebo (one to three capsules per day) for 12 weeks. Before being assigned to the drug intervention, participants with clinically significant agitation and their caregiver(s) will receive a structured psychosocial intervention for three weeks. If participants do not show a response, then they will be randomly assigned to the study drug or placebo.

Do I Qualify To Participate in This Study?

Minimum Age: 18 Years

Maximum Age: 109 Years

Must have:

  • Alzheimer's dementia diagnosis
  • Mini-Mental State Examination Telephone score of 3-20
  • Meets criteria for agitation in cognitive disorders per the International Psychogeriatric Association
  • Clinically significant agitation/aggression as assessed by the Neuropsychiatric Inventory
  • Availability of a caregiver who spends at least several hours per week with the participant, supervises his or her care, and is willing to accompany the participant to study visits and participate in the study
  • Use of antipsychotics for agitation or psychosis must be stable for at least seven days

Must NOT have:

  • Major depression in the past 90 days
  • Brain disease other than Alzheimer's that explains the dementia, such as 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 facility 
  • Contraindication to escitalopram, such as use of monoamine oxidase inhibitors in past 30 days or sensitivity to escitalopram or citalopram (Celexa) or any inactive ingredients
  • Prior failed treatment with citalopram or escitalopram for agitation
  • Indication for psychiatric hospitalization or acute suicidality
  • Changes in antipsychotics, anticonvulsants, or psychosis (delusions or hallucinations) within seven days requiring a change in antipsychotic treatment
  • Abnormal corrected QT interval as determined on electrocardiogram (more than 450 ms for men and 470 ms for women)
  • Severely reduced renal function in past 30 days as identified by a Glomerular filtration rate clearance of less than 30 ml per minute or reduced liver function
  • Prohibited medications within seven days:  antidepressants (other than 100 mg or less of trazodone per day at bedtime), benzodiazepines (other than lorazepam), or psychostimulants
  • Changes in dextromethorphan/quinidine, prazosin, and pimavanserin within two weeks
  • Use of medical marijuana within two weeks
  • Current participation in a clinical trial or study that may add a significant burden or affect study outcomes
  • Significant communicative impairments that would affect participation
  • Any condition that makes it medically inappropriate or risky to enroll in the trial

If I Qualify, Who Do I Contact?

Contact study personnel listed either under the general study contact or the location nearest you.

Study Contact
Dave Shade, JD
Stephan Ehrhardt, MD

Need Help?

Contact NIA’s Alzheimer’s and related Dementias Education and Referral (ADEAR) Center at 800-438-4380 or email ADEAR.

Where Is This Study Located?

Banner Sun Health Research Institute
Sun City, AZ 85351
Kelly Clark
Biomedical Research Foundation
Little Rock, AR 72205
Prasad Padala
University of Arkansas for Medical Sciences
Little Rock, AR 72205
Pat Savary
University of California Los Angeles/VA Greater Los Angeles Healthcare System
Los Angeles, CA 90073
Alex Alas
University of Southern California Keck School of Medicine Memory and Aging Center
Los Angeles, CA 90089
Mauricio Becerra, MD
Stanford Center for Precision Mental Health and Wellness
Stanford, CA 94305
Isabelle Cotto
District of Columbia
Washington DC VA Medical Center
Washington, DC 20422
Claudia Gunawan
Miami Jewish Health Systems
Miami, FL 33137
Alexander Gomez
Kansas School of Medicine-Wichita Center for Clinical Research
Wichita, KS 67214
Allie Archer
Johns Hopkins University School of Medicine, Bayview Medical Center
Baltimore, MD 21224
Mersania Jn Pierre
New Jersey
Hackensack Meridian Health
Hackensack, NJ 07601
Not yet recruiting
Domenica Vapore
New York
NYU Langone Health
New York, NY 10016
Not yet recruiting
Brittany Marti
Columbia University
New York, NY 10032
Jamie Graff
University of Rochester Medical Center
Rochester, NY 14620
Susan Salem-Spencer, RN, MSN
Stony Brook University Hospital
Stony Brook, NY 11794
Not yet recruiting
Nikhil Palekar, MD
University Hospitals Cleveland Medical Center/ Case Western
Cleveland, OH 44122
Srishti Ahuja
Ohio State University
Columbus, OH 43221
Emily Shalosky
Abington Neurological Associates, Ltd
Abington, PA 19001
Angela Robinson
Alzheimer Disease Research Center; University of Pittsburgh
Pittsburgh, PA 15213
Patricia Henderson
Baylor AT&T Memory Center
Dallas, TX 75231
Nazleen Sherali
UT Health San Antonio
San Antonio, TX 78229
Marlina Novoa
University of Virginia Adult Neurology
Charlottesville, VA 22903
Colleen Webber
Eastern Virginia Medical School
Norfolk, VA 23510
Kaitlin Romm

Who Sponsors This Study?

Lead: JHSPH Center for Clinical Trials

Collaborator Sponsor

  • National Institute on Aging (NIA)

Source: ID: NCT03108846

An official website of the U.S. government, managed by the National Institutes on Aging at the National Institutes of Health