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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 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 10 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 10 weeks
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
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Who is running the clinical trial?
Shenox Pharmaceuticals, LLCLead Sponsor
Mason Freeman, MDStudy DirectorMassachusetts General Hospital
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