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NMDA Receptor Antagonist

SHX-001 Active Low Dose for Depression

Phase 1
Waitlist Available
Research Sponsored by Shenox Pharmaceuticals, LLC
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 up to 10 weeks
Awards & highlights

Study Summary

The purpose of this study is to measure the amount of ketamine in blood over time in subjects diagnosed with Major Depressive Disorder (MDD) and explore the anti-depressive effects of ketamine delivered by transdermal patch.

Eligible Conditions
  • Depression

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 10 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 10 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Pharmacokinetics of SHX-001 (Cmax)
Pharmacokinetics of SHX-001 (T1/2)
Pharmacokinetics of SHX-001 (Tmax)
Secondary outcome measures
Anti-depressive effects of SHX-001
Other outcome measures
Safety objective as measured by Adverse Events (Safety and Tolerability of SHX-001)

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: SHX-001 Active high doseExperimental Treatment1 Intervention
ketamine transdermal patch
Group II: SHX-001 Active Low DoseExperimental Treatment1 Intervention
Ketamine transdermal patch
Group III: PlaceboPlacebo Group1 Intervention
placebo transdermal patch

Find a Location

Who is running the clinical trial?

Shenox Pharmaceuticals, LLCLead Sponsor
Mason Freeman, MDStudy DirectorMassachusetts General Hospital

Frequently Asked Questions

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

Who else is applying?

What site did they apply to?
Clinical Research Site
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
3+

What questions have other patients asked about this trial?

Recent research and studies
clinicaltrials.govStudy
Ketamine for Major Depressive Disorder
2018. "Ketamine for Major Depressive Disorder". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03721900.
All > Mdd
~2 spots leftby May 2025
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