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NMDA Receptor Antagonist

Ketamine for Major Depressive Disorder

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
Approved for 5 Other Conditions
All Individual Drugs Already Approved

Summary

This trial is testing a skin patch that releases ketamine to help people with major depression who don't respond well to standard treatments. The patch allows ketamine to enter the body slowly through the skin. Researchers are studying how much ketamine gets into the blood and its effects on depression symptoms. Ketamine, originally a general anesthetic, has shown promise as a rapid-acting antidepressant, particularly for treatment-resistant depression.

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

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

Awards & Highlights

Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

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
~2 spots leftby Dec 2025
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