Mecamylamine for Major Depressive Disorder (MDD)

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
National Institute on Drug Abuse, Baltimore, MD
Major Depressive Disorder (MDD)+7 More
Mecamylamine - Drug
Eligibility
18 - 65
All Sexes
What conditions do you have?
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Study Summary

This trial is testing how nicotine affects symptoms of depression and related brain function. People aged 18 to 60 who do not smoke or use nicotine products are eligible. Participants will have 3 or 4 study visits over 1 to 4 months. Each visit will include urine and breath tests, 3 MRI scans, and a blood test. Mecamylamine is used to treat Major Depressive Disorder (MDD). Mecamylamine has been previously approved by the FDA to treat a different condition.

Eligible Conditions

  • Major Depressive Disorder (MDD)
  • Substance Use Disorders (SUD)
  • Normal Physiology

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Major Depressive Disorder (MDD)

Study Objectives

4 Primary · 1 Secondary · Reporting Duration: Ongoing

At each scan visit
1.Resting-fMRI
2.Task-fMRI
3. Task and Resting State Brain
4.Nicotine effects and symptoms of MDD
Ongoing
Determine the relationship between blood-based biomarkers, such as inflammatory makers/metabolomics and nicotinic effects

Trial Safety

Safety Progress

1 of 3

Other trials for Major Depressive Disorder (MDD)

Trial Design

3 Treatment Groups

Arm 2: Nicotine Patch
1 of 3
Arm 3: Mecamylamine
1 of 3
Arm 1: Placebo
1 of 3
Experimental Treatment
Non-Treatment Group

420 Total Participants · 3 Treatment Groups

Primary Treatment: Mecamylamine · Has Placebo Group · N/A

Arm 2: Nicotine PatchExperimental Group · 2 Interventions: Nicotine Patch, Mecamylamine · Intervention Types: Drug, Drug
Arm 3: MecamylamineExperimental Group · 2 Interventions: Placebo Nicotine Patch, Mecamylamine · Intervention Types: Other, Drug
Arm 1: PlaceboPlaceboComparator Group · 2 Interventions: Placebo Nicotine Patch, Mecamylamine · Intervention Types: Other, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nicotine Patch
2011
Completed Phase 4
~11240
Mecamylamine
2010
Completed Phase 3
~590

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: ongoing
Closest Location: National Institute on Drug Abuse · Baltimore, MD
Photo of Baltimore 1Photo of Baltimore 2Photo of Baltimore 3
2006First Recorded Clinical Trial
1 TrialsResearching Major Depressive Disorder (MDD)
26 CompletedClinical Trials

Who is running the clinical trial?

National Institute on Drug Abuse (NIDA)Lead Sponsor
2,207 Previous Clinical Trials
5,610,388 Total Patients Enrolled
2 Trials studying Major Depressive Disorder (MDD)
382 Patients Enrolled for Major Depressive Disorder (MDD)
Amy Janes, Ph.D.Principal InvestigatorNational Institute on Drug Abuse (NIDA)
3 Previous Clinical Trials
1,392 Total Patients Enrolled

Eligibility Criteria

Age 18 - 65 · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are able and willing to provide written informed consent, which includes agreement to all Lifestyle Considerations.
You have a baseline (Hamilton Depression) HAM-D score indicative of current depression.
You have had at least one episode of major depression in the past, but no longer meet the criteria for major depression.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.