Ketamine Biomarker Validation

Part of paid clinical trials in New York, New York.

Sponsor
Soterix Medical
Study ID
NCT07307768
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

  • Treatment Resistant Depression (TRD)

Eligibility Criteria

Sex
ALL
Age
18 Years - 59 Years
Healthy Volunteers
Not accepted

Interventions

  • Ketamine (0.25 mg/kg) — DRUG
    Low level ketamine infusion therapy.
  • Ketamine (0.5 mg/kg) — DRUG
    Medium level ketamine infusion therapy.
  • Ketamine (0.75 mg/kg) — DRUG
    High level ketamine infusion therapy.

Study Details

We will be developing an EEG-based biomarker for the effects of ketamine infusion in patients with Depression. We will be analyzing the effects of ketamine infusion on Depression symptoms and EEG signals.

Key Dates

Start date
Dec 20, 2025
Status verified
Dec 2025
Primary completion
Dec 1, 2027
Completion
Mar 1, 2028

Study Design

Enrollment
20 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Low level ketamine
    0.25 mg/kg ketamine infusion
  • Experimental: Medium level ketamine
    0.5 mg/kg ketamine infusion
  • Experimental: High level ketamine
    0.75 mg/kg ketamine infusion

Primary Outcome Measure

Hamilton Depression Rating Scale (HDRS) 22 [ Time Frame: Baseline, Hour 1, Hour 4, Hour 24, and Hour 72 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Columbia University Irving Medical CenterNew YorkNew York10032
Yishai Valter, MS
[email protected]
8889908327

Find similar trials in New York, NY

By research site
Columbia University Irving Medical Center· New York, NY

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