Effects of Acute Exercise and Ibuprofen on Symptoms, Immunity, and Neural Circuits in Bipolar Depression

Part of paid clinical trials in Tulsa, Oklahoma.

Sponsor
Laureate Institute for Brain Research, Inc.
Study ID
NCT06088732
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Bipolar Depression

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Not accepted

Interventions

  • Exercise Session — OTHER
    30 min cycling on bicycle ergometer at 60% peak power output
  • Ibuprofen 800 mg — DRUG
    A single oral dose of Ibuprofen
  • Rest — OTHER
    Resting for 30 min in chair
  • Placebo — DRUG
    Matched placebo

Study Details

This is a 2x2, within-subjects, cross-over trial to test the anti-depressant effects of acute exercise in 20 participants with bipolar depression. Participants will complete four experimental sessions, two with an exercise challenge and two with a resting control condition in a counterbalanced order. Participants will receive either 800mg of ibuprofen or placebo before exercise or rest in order to test whether blocking the inflammatory response to exercise interferes with the neural and psychological effects of exercise.

Key Dates

Start date
Mar 12, 2024
Status verified
May 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
20 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Session 1
    Exercise (30 min on bicycle ergometer at 60% peak power output) and a single oral dose 800mg of ibuprofen
  • Active Comparator: Session 2
    Exercise (30 min on bicycle ergometer at 60% peak power output) and matching placebo
  • Active Comparator: Session 3
    30 minutes rest (sitting in chair) and a single oral dose 800mg of ibuprofen
  • Placebo Comparator: Session 4
    30 minutes rest (sitting in chair) and matching placebo

Primary Outcome Measure

Inflammation [ Time Frame: Difference between IL-6 at baseline and two hours post intervention ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Laureate Institute for Brain ResearchTulsaOklahoma74136
Jonathan Savitz, PhD
[email protected]
918-502-5104

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By research site
Laureate Institute for Brain Research· Tulsa, OK

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