Effects of Acute Exercise and Ibuprofen on Symptoms, Immunity, and Neural Circuits in Bipolar Depression
Eligible age
18–55 yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
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About this study
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.
Sponsor: Laureate Institute for Brain Research, Inc.
You may qualify if…
- ✓ 1. Provision of signed and dated informed consent form
- ✓ 2. Has an established residence and phone
- ✓ 3. Agrees to and is eligible for behavioral testing, magnetic resonance imaging, and blood draws.
- ✓ 4. Stated willingness to comply with all study procedures and lifestyle considerations (see Section 5.3, Lifestyle Considerations) and availability for the duration of the study
- ✓ 5. Males and females; Age 18-55 years
- ✓ 6. DSM-V diagnosis of bipolar disorder
- ✓ 7. Has a current major depressive episode
- ✓ 8. Depression at enrollment of sufficient severity to score \> 11 on the QIDS
You may not qualify if…
- ✕ 1. Diagnosis of any other major psychiatric disorder such as schizoaffective disorder, schizophrenia, or current psychotic depression
- ✕ 2. A history of bipolar disorder with rapid cycling
- ✕ 3. Concurrent manic symptoms of sufficient severity to pose a substantial risk of the development of a manic episode (\>19 on the YMRS)
- ✕ 4. Current drug or alcohol or substance use disorder moderate or severe, except nicotine (within 6 months for severe use disorder; 2 months for moderate use disorder)
- ✕ 5. Volunteers currently receiving more than 4 mood-relevant psychotropic medications in a daily regimen (since this may signify a more brittle or complex clinical state)
- ✕ 6. Taking any of the following medications: medications with significant interactions with ibuprofen; immune-modulating medications (e.g. oral steroids); regular use of NSAIDs (\> 3 times per week)
- ✕ 7. Current or prior cardiac disease, cardiac arrhythmia (e.g. supraventricular tachycardia, atrial fibrillation, ventricular fibrillation), or history of cardiac ablation therapy
- ✕ 8. Unstable medical condition, including significant respiratory disease (e.g., asthma, reactive airway disease (i.e., exercise induced asthma), or chronic obstructive pulmonary disease (COPD)), liver disease, hypothyroidism (i.e., condition not adequately stabilized for 3 months), or other conditions likely to require hospitalization or with a life expectancy of \< 6 months (e.g., cancer).
Where it's recruiting
Tulsa
Source: ClinicalTrials.gov · NCT06088732 · last updated 2025-05-23