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

University of Illinois

Status and phase

Not yet enrolling

Phase 2

Conditions

Depression

Treatments

Drug: Clemastine Fumarate

Drug: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT06591091

2024-0636

Details and patient eligibility

About

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.

Full description

Geriatric depression, also known as late-life depression, is a type of major depression that affects people who are 60 years old or older. It can be difficult to treat and often comes back after treatment. It can also lead to problems with memory and thinking. Some studies have found that problems with the white matter in the brain can make it harder to treat depression in older adults. White matter helps with communication in the brain. A new study suggests that a medicine called clemastine might be able to improve the white matter in the brain. Clemastine is usually used as an antihistamine, but it might also help the brain repair itself. The goal of this study is to find out if 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. The study will involve two groups of participants. One group will receive the standard antidepressant treatment along with a placebo, while the other group will receive the standard antidepressant treatment along with clemastine. The investigators will compare the effects of these two treatments over a period of 12 weeks. The investigators will measure the improvement in white matter using special brain imaging techniques. The investigators will also assess the participants' mood, memory, and thinking abilities, and keep track of any side effects or problems caused by the treatments. Overall, this study has the potential to contribute valuable insights into the treatment of geriatric depression, alleviate depressive symptoms, enhance cognitive function, and potentially open up new avenues for future research and therapeutic approaches.

Enrollment

80 estimated patients

Sex

All

Ages

60+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

80 participants in 2 patient groups, including a placebo group

Clemastine arm

Experimental group

Description:

Participants in the clemastine arm of the study will receive clemastine 5.36 mg PO twice daily for 12 weeks. Based on clinical assessment, participants will also receive one of the following antidepressant medications: SSRI: Fluoxetine, sertraline, citalopram, escitalopram, vilazodone, vortioxetine SNRI: Venlafaxine, desvenlafaxine, duloxetine, levomilnacipran Augmentation: Bupropion and mirtazapine (monotherapy option in addition to first augmentation level), aripiprazole and quetiapine (second augmentation level). Allowable concomitant medications parallel clinical practice. These can include trazodone (up to 100mg nightly) for insomnia or as-needed use of benzodiazepines for concomitant anxiety, up to a maximum daily dose equivalent to lorazepam 2mg daily. Psychotropic medications used for other indications (such as tricyclics or gabapentin for pain) are allowable. Concomitant psychotherapy is allowed.

Treatment:

Drug: Clemastine Fumarate

Placebo arm

Placebo Comparator group

Description:

Participants in the placebo arm of the study will receive a placebo capsule PO twice daily for 12 weeks.

Treatment:

Drug: Placebo