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

Plain English Summary

Clemastine for Improving White Matter and Boosting Antidepressant Response in Late-life Depression is a Phase 2 clinical trial sponsored by University of Illinois at Chicago studying Depression. This trial tests if clemastine, an antihistamine, can improve brain white matter and boost the effectiveness of antidepressant treatment in older adults with depression. It is for individuals over 60 years old diagnosed with major depression who are seeking antidepressant treatment and have moderate to severe symptoms. Participants will receive either clemastine or a placebo, and will undergo regular assessments of depression symptoms, cognitive function, and brain imaging. Standard antidepressant treatments are the current alternative for managing depression in this age group. The trial aims to enroll 80 participants.

Official 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.

Who Can Participate

Here is what you need to know about eligibility for this trial. You can join if you are over 60, have been diagnosed with major depression, have a score of 15 or higher on the MADRS depression scale, and are looking for antidepressant treatment. You cannot join if you have other significant psychiatric disorders (besides mild anxiety related to depression), a history of substance abuse in the past year, or a history of developmental disorders. You also cannot join if you have had thoughts of suicide in the past month, acute grief, psychosis, a primary neurological disorder (like dementia or stroke), unstable medical conditions, or any reason you cannot have an MRI. Individuals who have had electroconvulsive therapy (ECT) in the last 6 months are also excluded. This trial is studying Depression, so participants generally need a confirmed diagnosis.

What They're Measuring

The primary outcomes measure how side effects are experienced, the severity of depression symptoms, and changes in the brain's white matter structure, indicating whether the treatment is safe, effecti The specific primary outcome measures are: Frequency, Intensity and Burden of Side Effects Rating Scale (12 weeks); Montgomery-Asberg Rating Scale for Depression (12 weeks); Quantitative Anisotropy (12 weeks); Fractional Anisotropy (12 weeks). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This trial is in Phase 2, which tests whether the treatment actually works against the target condition. Phase 2 trials involve 100-300 patients and continue to monitor safety while evaluating effectiveness. This phase often tests different dosages to find the optimal amount. About 33% of Phase 2 drugs advance to Phase 3. If successful, the treatment will move to large-scale Phase 3 trials needed for FDA approval.

Why This Trial Matters

This trial addresses a significant unmet need in treating late-life depression by exploring a novel approach to improve brain white matter, potentially enhancing antidepressant efficacy and cognitive Phase 2 success would typically lead to larger Phase 3 trials needed for regulatory approval. This research targets Depression, where improved treatment options are needed.

Investor Insight

This Phase 2 trial signals potential for a new therapeutic avenue in a large and growing market for depression treatments, with clemastine offering a potentially repurposed and cost-effective option i Phase 2 trials have approximately a 15-20% chance of eventually gaining FDA approval.

Is This Trial Right for Me?

Ask your doctor about the potential benefits and risks of clemastine and standard antidepressants. Understand what participation involves, including the frequency of visits, tests, and potential side effects. Be prepared for regular assessments of your mood, thinking abilities, and brain imaging scans. The trial is being conducted at multiple sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

• Study Type: INTERVENTIONAL
• Allocation: RANDOMIZED
• Model: PARALLEL
• Masking: QUADRUPLE
• Enrollment: 80 participants

Interventions

• DRUG: Clemastine Fumarate — Listed in arm/group description
• DRUG: Placebo — Listed in arm/group description

Primary Outcomes

• Frequency, Intensity and Burden of Side Effects Rating Scale (12 weeks)
• Montgomery-Asberg Rating Scale for Depression (12 weeks)
• Quantitative Anisotropy (12 weeks)
• Fractional Anisotropy (12 weeks)

Secondary Outcomes

• Trail Making Test Part A and Part B (12 weeks)
• Orientation Dispersion Index (12 weeks)
• Neurite Density Index (12 weeks)

Full 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

Frequently Asked Questions

Related Conditions

• Depression
• Major Depressive Disorder
• Late-life Depression
• Geriatric Depression
• Cognitive Impairment
• White Matter Abnormalities
• Neuroinflammation
• Antidepressant Treatment
• Anxiety Disorders
• Neurological Disorders

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