Clemastine for Improving White Matter and Boosting Antidepressant Response in Late-life Depression

Part of paid clinical trials in Chicago, Illinois.

Sponsor
University of Illinois at Chicago
Study ID
NCT06591091
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
60 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Clemastine Fumarate — DRUG
    Listed in arm/group description
  • Placebo — DRUG
    Listed in arm/group description

Study Details

The goal of this study is to find out if the antihistamine, clemastine, can make the white matter in the brain better in older adults with depression. The study will also determine whether this improvement can make antidepressant treatment work better, reduce depressive symptoms, and improve memory and thinking.

Key Dates

Start date
Dec 10, 2025
Status verified
Aug 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
80 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Clemastine arm
    Participants in the clemastine arm of the study will receive clemastine 5.36 mg PO twice daily for 12 weeks. Based on clinical assessment, participants will also receive one of the following antidepressant medications: SSRI: Fluoxetine, sertraline, citalopram, escitalopram, vilazodone, vortioxetine SNRI: Venlafaxine, desvenlafaxine, duloxetine, levomilnacipran Augmentation: Bupropion and mirtazapine (monotherapy option in addition to first augmentation level), aripiprazole and quetiapine (second augmentation level). Allowable concomitant medications parallel clinical practice. These can include trazodone (up to 100mg nightly) for insomnia or as-needed use of benzodiazepines for concomitant anxiety, up to a maximum daily dose equivalent to lorazepam 2mg daily. Psychotropic medications used for other indications (such as tricyclics or gabapentin for pain) are allowable. Concomitant psychotherapy is allowed.
  • Placebo Comparator: Placebo arm
    Participants in the placebo arm of the study will receive a placebo capsule PO twice daily for 12 weeks.

Primary Outcome Measure

Frequency, Intensity and Burden of Side Effects Rating Scale [ Time Frame: 12 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Illinois College of MedicineChicagoIllinois60612
Olusola Ajilore, MD, PhD
[email protected]
312-413-4562

Find similar trials in Chicago, IL

By condition
Depression
By specialty
PsychiatryMental healthBehavioral health
By research site
University of Illinois College of Medicine· Chicago, IL

Related Studies