Cognitive Dysfunction and Inflammation in Depression: Experimental Inhibition Via Infliximab

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Massachusetts General Hospital
Study ID
NCT06136546
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
25 Years - 50 Years
Healthy Volunteers
Not accepted

Interventions

  • Infliximab — DRUG
    Intravenous infusion of infliximab
  • Placebo — OTHER
    Intravenous infusion of saline solution (matching in color and consistency in infliximab)

Study Details

This study is a mechanistic randomized controlled trial that investigates whether inhibition of tumor necrosis factor signaling via intravenous infusion of infliximab improves psychomotor speed and executive functioning in depressed individuals who exhibit an inflammatory phenotype.

Key Dates

Start date
Jan 23, 2025
Status verified
May 2025
Primary completion
Aug 31, 2028
Completion
Jan 31, 2029

Study Design

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

Arms

  • Experimental: Infliximab
    Participants in this arm will receive 5 mg/kg of infliximab via an in-dwelling catheter.
  • Placebo Comparator: Placebo
    Participants in this arm will receive saline as placebo via an in-dwelling catheter.

Primary Outcome Measure

Psychomotor Speed (TestMyBrain: Simple Reaction Time) [ Time Frame: Repeated measures over two weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Massachusetts General HospitalBostonMassachusetts02114
Naoise Mac Giollabhui, PhD
[email protected]
6177241000
Naoise Mac Giollabhui, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Boston, MA

By condition
Depression
By specialty
PsychiatryMental healthBehavioral health
By research site
Massachusetts General Hospital· Boston, MA

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