Treatment for Melancholia

Phase-Based Estimates
3
Effectiveness
3
Safety
NYU Langone Health, New York, NY
Melancholia+3 More
Eligibility
18+
All Sexes
Eligible conditions
Melancholia

Study Summary

This study is evaluating whether a reduction in depressive symptoms will be associated with a normalization of CSF AD biomarkers as well as peripheral inflammatory markers.

See full description

Eligible Conditions

  • Melancholia
  • Depressive Disorder
  • Psychosis, Involutional
  • Alzheimer Disease
  • Major Depressive Disorder (MDD)
  • Depressive Disorder, Major

Treatment Effectiveness

Effectiveness Estimate

3 of 3
This is better than 93% of similar trials

Study Objectives

This trial is evaluating whether Treatment will improve 4 primary outcomes and 3 other outcomes in patients with Melancholia. Measurement will happen over the course of Baseline, Week 8.

Baseline, Week 8
Change in Cerebrospinal Fluid (CSF) Aβ40 Biomarker Levels
Change in Cerebrospinal Fluid (CSF) Aβ42 Biomarker Levels
Change in Cerebrospinal Fluid (CSF) P-tau Biomarker Levels
Change in Cerebrospinal Fluid (CSF) T-tau Biomarker Levels
Change in Plasma Aβ Biomarker Levels
Change in Scores on Montgomery-Asberg Depression Ration Scale (MADRS)
Change in Vascular Dysfunction (VD) Biomarker Levels

Trial Safety

Safety Estimate

3 of 3
This is better than 85% of similar trials

Trial Design

2 Treatment Groups

Escitalopram (ESC)
Placebo group

This trial requires 90 total participants across 2 different treatment groups

This trial involves 2 different treatments. Treatment is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 4 and have been shown to be safe and effective in humans.

Escitalopram (ESC)
Drug
Placebo (PBO)
Drug

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, week 8
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly baseline, week 8 for reporting.

Closest Location

NYU Langone Health - New York, NY

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Have results of a physical examination, neurological examination, vitals, and EKG within normal limits at screening.
Cognitively unimpaired at screening visit as defined by Mini-Mental State Examination (MMSE) >27.
Clinical Dementia Rating Scale (CDR) Global of 0.
A score of 85 or greater on the RBANS delayed memory index score.
Montgomery-Åsberg Depression Rating Scale (MADRS) ≥18.
Male and female subjects, age 60+ years inclusive, at the time of signing the informed consent.
Meeting Structured Clinical Interview (SCID-5-RV) for DSM-5 criteria for Major depressive disorder.
Fluent in English, because some of the instruments used in this study have not been translated and validated in other languages, and are able to read at a 6th grade level or equivalent, as determined by the PI.
Medically stable with no significant cerebrovascular, neurological, or systemic disease expected to interfere with the study.
Adequate auditory acuity and normal-to-corrected vision.

Patient Q&A Section

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Are there any geographic restrictions to consider when applying for this trial?

Patients from any state can participate in this trial, so long as they are able to attend all treatment sessions.

Will my insurance cover participating in this trial?

In order to understand how insurance coverage works for this trial, you will need to contact the study coordinator.

See if you qualify for this trial
Get access to this novel treatment for Melancholia by sharing your contact details with the study coordinator.