RightFit
RecruitingPhase 2

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
60 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether clemastine, an allergy medicine, can improve the brain’s white matter in adults over 60 with depression. White matter helps brain cells send messages. The study also tests whether this change helps antidepressants work better, eases depression, and improves memory and thinking.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are older than 60.
  • You have major depression, either for the first time or after past episodes.
  • You score 15 or higher on the MADRS test, which rates depression symptoms.
  • You are seeking treatment with antidepressant medicine.
  • You score above 24 on the MoCA test of memory and thinking.
  • You speak English or Spanish fluently.

Who can't join

  • You have another mental health disorder, or have ever had psychosis (trouble knowing what is real). Certain phobias and anxiety that occurs only during depression are allowed.
  • You have had alcohol or drug abuse or dependence in the past year.
  • You have a history of a developmental disorder or an IQ score below 70.
  • You have had serious thoughts of suicide in the past month, based on a screening test, or recent grief lasting less than one month.
  • You have a main brain or nerve disorder, such as dementia, stroke, a brain tumor, or epilepsy (a seizure disorder).
  • You have a medical illness that is not stable and needs urgent treatment.
  • You cannot safely have an MRI brain scan.
  • You have had electroconvulsive therapy (ECT), a treatment using electrical pulses to the brain, in the past 6 months.

Simplified for readability. The official criteria below are what the study team uses.

Official 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

Study sites (1)

IL