Clemastine to boost brain white matter and antidepressant response in older adults with depression

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 2 interventional trial investigates whether clemastine fumarate, combined with standard antidepressant therapy, can improve white matter integrity and enhance antidepressant response in adults over 60 with major depressive disorder. Participants are randomized to receive clemastine or placebo for 12 weeks while continuing their usual antidepressant treatment. Primary outcomes include changes in brain white matter measured by imaging, along with mood and cognitive assessments, and safety monitoring. The study targets late-life depression, where white matter health may influence treatment outcomes. Recruitment is conducted at the University of Illinois College of Medicine in Chicago with collaboration from Cures Within Reach.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 Criteria:

* 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

Where it's running

• University of Illinois College of Medicine
  Chicago, Illinois, United States Recruiting

Study contacts

• Study coordinator: Olu A Ajilore, MD, PhD
• Email: oajilore@uic.edu
• Phone: 312-413-4562

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.