RecruitingPhase 1Phase 2NCT06088732

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


Sponsor

Laureate Institute for Brain Research, Inc.

Enrollment

20 participants

Start Date

Mar 12, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 55 Years

Plain Language Summary

Simplified for easier understanding

This study is investigating whether a single session of exercise or a single dose of ibuprofen (an anti-inflammatory pain reliever) can ease depressive symptoms and reduce inflammation in people with bipolar disorder who are currently experiencing depression. Researchers are using brain imaging and blood tests to understand how each intervention affects the brain and immune system. **You may be eligible if...** - You are between 18 and 55 years old - You have a DSM-5 diagnosis of bipolar disorder - You are currently experiencing a depressive episode - Your depression score is above 11 on the QIDS scale - Your BMI is between 18.5 and 35 - You have been on stable medication for at least 4 weeks (or are not medicated and judged appropriate by a doctor) **You may NOT be eligible if...** - You have another major psychiatric condition such as schizophrenia - You have a history of rapid cycling bipolar disorder - You have a significant medical condition that prevents MRI or exercise - You have a known allergy or intolerance to ibuprofen - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERExercise Session

30 min cycling on bicycle ergometer at 60% peak power output

DRUGIbuprofen 800 mg

A single oral dose of Ibuprofen

OTHERRest

Resting for 30 min in chair

DRUGPlacebo

Matched placebo


Locations(1)

Laureate Institute for Brain Research

Tulsa, Oklahoma, United States

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NCT06088732


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