NCT06591091 Clemastine for Improving White Matter and Boosting Antidepressant Response in Late-life Depression
| NCT ID | NCT06591091 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | University of Illinois at Chicago |
| Condition | Depression |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2025-12-10 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 80 participants in total. It began in 2025-12-10 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 improvement can make antidepressant treatment work better, reduce depressive symptoms, and improve memory and thinking.
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06591091 clinical trial?
This trial is open to participants of all sexes, aged 60 Years or older, studying Depression. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06591091 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06591091 currently recruiting?
Yes, NCT06591091 is actively recruiting participants. Contact the research team at oajilore@uic.edu for enrollment information.
Where is the NCT06591091 trial being conducted?
This trial is being conducted at Chicago, United States.
Who is sponsoring the NCT06591091 clinical trial?
NCT06591091 is sponsored by University of Illinois at Chicago. The trial plans to enroll 80 participants.
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