Status:

NOT_YET_RECRUITING

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

Lead Sponsor:

University of Illinois at Chicago

Collaborating Sponsors:

Cures Within Reach

Conditions:

Depression

Eligibility:

All Genders

60+ years

Phase:

PHASE2

Brief Summary

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 improv...

Detailed Description

Geriatric depression, also known as late-life depression, is a type of major depression that affects people who are 60 years old or older. It can be difficult to treat and often comes back after treat...

Eligibility Criteria

Inclusion

  • Age \> 60 years
  • Diagnosis of major depressive disorder, single or recurrent episode (DSM5)
  • Symptom Severity: MADRS ≥ 15
  • Seeking antidepressant treatment
  • Cognition score of MoCA \>24
  • Fluent in English or Spanish

Exclusion

  • Other Axis I psychiatric disorders, except for simple phobia or anxiety disorders present uniquely during the depressive episode (e.g., generalized anxiety disorder (GAD) or panic disorder symptoms)
  • History of alcohol or drug dependence or abuse in the last year
  • History of a developmental disorder or history of IQ (intelligence quotient) \<70
  • Acute suicidality ideation within the past month as determined by the Columbia Suicide Severity Rating Scale (C-SSRS)
  • Acute grief (\<1 month)
  • Current or past psychosis
  • Primary neurological disorder, including dementia, clinical stroke, brain tumor, epilepsy, etc.
  • Presence of unstable medical illness requiring urgent treatment
  • Any MRI contraindication
  • Electroconvulsive Therapy (ECT) in last 6 months

Key Trial Info

Start Date :

September 1 2025

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

March 1 2026

Estimated Enrollment :

80 Patients enrolled

Trial Details

Trial ID

NCT06591091

Start Date

September 1 2025

End Date

March 1 2026

Last Update

September 4 2025

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