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.
Age > 60 years
Diagnosis of major depressive disorder, single or recurrent episode (DSM5)
Symptom Severity: MADRS ≥ 15
Seeking antidepressant treatment
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)
Parallel
Clemastine Fumarate
DrugListed in arm/group description
Placebo
DrugListed in arm/group description
Frequency, Intensity and Burden of Side Effects Rating Scale
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 Depression
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 Anisotropy
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 Anisotropy
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
Trail Making Test Part A and Part B
The investigators will examine the effectiveness of an antidepressant plus clemastine (5.36 mg twice daily) compared to antidepressant plus placebo on cognitive outcomes as indexed by Trail Making Test Parts A and B. The Trail Making Test A and B is scored by the time to completion (seconds) and number of errors, with higher scores indicating worse performance. For TMT Part A and Part B, the "average" and "deficient" scores are categorized as follows: TMT Part A 29 seconds (average) Over 79 seconds (Deficient) TMT Part B 75 seconds (average) Over 273 seconds (Deficient)
Orientation Dispersion Index
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 neurite orientation dispersion and density imaging (NODDI)-derived orientation dispersion index (ODI). The ODI has no units but ranges from 0-1, with higher values indicating more neurite dispersion.
Neurite Density Index
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 neurite orientation dispersion and density imaging (NODDI)-derived measured neurite density index (NDI). The NDI has no units but ranges from 0-1, with higher values indicating more intracellular diffusion
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University of Illinois at Chicago
Lead sponsor
Cures Within Reach
Collaborator
