Clemastine for Improving White Matter and Boosting Antidepressant Response in Late-life Depression
Recruiting · NCT06591091 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Illinois at Chicago
View the official record on ClinicalTrials.gov →Interventions studied
Clemastine FumaratePlacebo
What this trial is about
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.
Who can take part
Age range
60 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
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 is running
1 location listed across 1 US state.
- University of Illinois College of Medicine - Chicago, Illinois, United States