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New treatment option for Depression
Official title Clemastine for Improving White Matter and Boosting Antidepressant Response in Late-life Depression
ClinicalTrials.gov ID: NCT06591091
What this study is testing
What is Clemastine Fumarate?
Clemastine Fumarate is an investigational medicine, being studied as a potential treatment for depression.
Also referred to as Clemastine, Tavist Allergy.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 12 weeks
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 60 and older
You may be able to join if
- 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
You likely can't join if
- Other Axis I psychiatric disorders, except for simple phobia or anxiety disorders present uniquely during the depressive episode (e.g., generalized...
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Chicago, Illinois, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 12 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 60 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chicago, Illinois, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.