Clemastine for Improving White Matter and Boosting Antidepressant Response in Late-life Depression
This study is investigating whether clemastine fumarate, an antihistamine, can improve the brain's white matter in older adults (age 60 and above) with depression. The goal is to see if this improvement can help antidepressant treatments work better, reduce depression symptoms, and improve memory and thinking. You may be eligible if you are over 60, have major depressive disorder with a specific symptom severity (MADRS ≥ 15), are seeking antidepressant treatment, and meet other criteria. Success will be measured by changes in side effects, depression symptoms, and white matter in the brain after 12 weeks. The current recruitment status is unclear.
- Study design
- This interventional study plans to enroll 80 participants. It involves two groups: one receiving standard antidepressant treatment with clemastine fumarate, and the other receiving standard antidepressant treatment with a placebo.
- What's involved
- Participants will receive treatment and be assessed over a period of 12 weeks. Specific visits, procedures, or tests are not detailed beyond these assessments.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be assessed at 12 weeks for side effects, depression symptoms, and white matter changes.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Clemastine for Improving White Matter and Boosting Antidepressant Response in Late-life Depression
At a glance
Conditions
Where it's being run
1 sites across 1 statesWho to contact
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Inclusion
Exclusion
What this trial measures
- Frequency, Intensity and Burden of Side Effects Rating Scale12 weeks
The investigator will examine the safety of clemastine using the Frequency, Intensity, and Burden of Side Effects Rating Scale (FIBSER). The FIBSER is scored from 0-6, with higher scores indicating worse outcomes
- Montgomery-Asberg Rating Scale for Depression12 weeks
The investigators will examine the effectiveness of an antidepressant plus clemastine (5.36 mg twice daily) compared to antidepressant plus placebo on clinical outcomes as indexed by the Montgomery-Asberg Rating Scale for Depression (MADRS). The MADRS is scored from 0-60, with higher scores indicating a worse outcome
- Quantitative Anisotropy12 weeks
The investigators will measure the impact of an antidepressant plus clemastine (5.36 mg twice daily) compared to antidepressant plus placebo on white matter integrity as indexed by change in quantitative anisotropy (QA). QA has no units but is measured from 0 to 1 and a higher indicates better white matter integrity
- Fractional Anisotropy12 weeks
The investigators will measure the impact of an antidepressant plus clemastine (5.36 mg twice daily) compared to antidepressant plus placebo on white matter integrity as indexed by change in fractional anisotropy (FA). FA has no units but is measured from 0 to 1 and a higher indicates better white matter integrity