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Selective Serotonin Reuptake Inhibitor

Antidepressants for Depression (NEMO Trial)

Phase 4

Waitlist Available

Led By Howard J Aizenstein, MD, Ph.D.

Research Sponsored by Howard Aizenstein

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and week 12

Awards & highlights

NEMO Trial Summary

This trial is testing a new treatment for depression in people 60 and older. It will involve 4 MRIs to track changes in brain function.

Who is the study for?

The NEMO study is for individuals aged 60 or older who are currently experiencing depression, with a specific focus on those who have not been diagnosed with dementia or other medical conditions that significantly affect mood. Participants must be able to undergo MRI scans and speak English well enough for neuropsychological testing.Check my eligibility

What is being tested?

This trial aims to understand brain changes in depressed seniors by providing them either Escitalopram, Levomilnacipran, or a placebo pill. It includes four MRI scans over the treatment period to monitor brain function and predict medication response.See study design

What are the potential side effects?

Potential side effects from Escitalopram and Levomilnacipran can include nausea, headache, sleep disturbances, sexual dysfunction, increased sweating, constipation or diarrhea. The severity of side effects varies among individuals.

NEMO Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, week 1, and week 12

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, week 1, and week 12

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 1, and week 12 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Functional Connectivity

Change in Montgomery Asberg Depression Rating Scale Score

Secondary outcome measures

Age of Onset

Antidepressant Treatment History Questionnaire (ATHF)

Duration of Illness

+4 more

NEMO Trial Design

4Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: Escitalopram Pill (Phase II)Experimental Treatment1 Intervention

Participants who were in the placebo arm for Phase I who do not show signs of response to treatment by week 6 (defined as either a MADRS score of greater than 12 or less than a 30% reduction in MADRS score to be deemed a non-responder) will be given the option to have an open-label trial of escitalopram in Phase II. Participants in this arm will receive an initial dose of 5 mg. Further titrations throughout the 6 week duration of Phase 2 (maximum dose of 20 mg) will be decided based on clinical response and tolerability. The medication will be taken by mouth in pill form, once daily. Note: This arm no longer applies as of 5/16/18. Participants are now randomly assigned to Lexapro or Fetzima and the assignment does not change throughout the study.

Group II: Escitalopram PillActive Control1 Intervention

Participants in this arm will receive an initial dose of 5 mg. Further titrations will be decided based on clinical response and tolerability (maximum dose of 20 mg). The medication will be taken by mouth in pill form, once daily.

Group III: Levomilnacipran PillActive Control1 Intervention

Participants will receive an initial dose of 20 mg blinded levomilnacipran. At day 7, the doses will be titrated to 40 mg of levomilnacipran. Further titrations (maximum dose of 120 mg of levomilnacipran) will be decided based on clinical response and tolerability. The medication will be taken by mouth in pill form, once daily.

Group IV: PlaceboPlacebo Group1 Intervention

Participants will be given a sugar pill (placebo) to be taken by mouth once daily for the 6 week duration of Phase I. As this arm is also double-blinded, participants will receive an initial dose of 5 mg and further titrations (maximum dose of 20 mg) will be decided based on clinical response and tolerability. Note: This arm no longer applies as of 5/16/18. Participants are now randomly assigned to Lexapro or Fetzima.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Escitalopram Pill

2017

Completed Phase 4

~60

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Howard AizensteinLead Sponsor

National Institute of Mental Health (NIMH)NIH

2,786 Previous Clinical Trials

2,689,710 Total Patients Enrolled

666 Trials studying Depression

251,527 Patients Enrolled for Depression

Weill Cornell Institute of Geriatric PsychiatryUNKNOWN

Media Library

Escitalopram Pill (Selective Serotonin Reuptake Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03128021 — Phase 4

Depression Research Study Groups: Escitalopram Pill, Escitalopram Pill (Phase II), Levomilnacipran Pill, Placebo

Depression Clinical Trial 2023: Escitalopram Pill Highlights & Side Effects. Trial Name: NCT03128021 — Phase 4

Escitalopram Pill (Selective Serotonin Reuptake Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03128021 — Phase 4

Depression Patient Testimony for trial: Trial Name: NCT03128021 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the regulatory body approved Escitalopram Pill for general use?

"Escitalopram Pill is a 4th phase drug, so it receives the highest safety rating of 3."

Answered by AI

Are there any vacancies for potential participants in this clinical study?

"Indeed, according to clinicaltrials.gov's records, this trial commenced on May 24th 2017 and is in the process of enlisting 140 individuals at one medical site. The study was most recently updated on January 5th 2022."

Answered by AI

How many participants have been recruited to take part in this scientific trial?

"Yes, according to clinicaltrials.gov information this medical trial is actively enrolling patients with the first post dating back to May 24th 2017 and last edited on January 5th 2022. 140 participants are needed at a single location for this study."

Answered by AI

What key goals is this research endeavor aiming to achieve?

"This trial will measure the Change in Baseline MADRS score over a 12-week period, with its primary outcome being an alteration of Functional Connectivity. Secondary outcomes include Response Styles Questionnaire- Rumination (RSQ-Rumination) to examine cognitive biases during rumination; Duration of Illness and Antidepressant Treatment History Questionnaire (ATHF), both used as covariates for functional connectivity analysis."

Answered by AI

What other experiments have been conducted on Escitalopram Pill?

"At present, 23 clinical trials for Escitalopram Pill are on-going and 5 of them have progressed to Phase 3. Of the 45 sites across America that offer this medication trial, a significant concentration is based in Cincinnati, Ohio."

Answered by AI