NCT06088732

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

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Laureate Institute for Brain Research, Inc. · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Bipolar Depression

Interventions

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

Timeline

• Start date: 2024-03-12
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2023-10-18
• Last updated: 2025-05-23

Locations

1 site across 1 country: United States