Actively Recruiting
Effects of Acute Exercise and Ibuprofen on Symptoms, Immunity, and Neural Circuits in Bipolar Depression
Led by Laureate Institute for Brain Research, Inc. · Updated on 2025-05-23
20
Participants Needed
1
Research Sites
146 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Effects of Acute Exercise and Ibuprofen on Symptoms, Immunity, and Neural Circuits in Bipolar Depression
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed and dated informed consent provided
- Established residence and phone number
- Eligible and agrees to behavioral testing, MRI scans, and blood draws
- Willingness to comply with all study procedures and lifestyle requirements
- Male or female aged 18 to 55 years
- DSM-V diagnosis of bipolar disorder
- Current major depressive episode
- Depression severity scoring above 11 on the QIDS at enrollment
- Stable medication use for at least 4 weeks or judged appropriate if non-medicated
- Body mass index between 18.5 and 35
You will not qualify if you...
- Diagnosis of other major psychiatric disorders like schizoaffective disorder, schizophrenia, or psychotic depression
- History of rapid cycling bipolar disorder
- Severe manic symptoms posing substantial risk (YMRS score above 19)
- Moderate or severe drug, alcohol, or substance use disorder within recent months, except nicotine
- Using more than four mood-relevant psychotropic medications daily
- Taking medications that interact with ibuprofen or immune-modulating drugs, or regular NSAID use over three times per week
- Current or prior cardiac disease, arrhythmia, or cardiac ablation therapy
- Unstable medical conditions including respiratory diseases, liver disease, unstable hypothyroidism, or life-threatening illnesses
- Claustrophobia preventing participation in MRI scans
- Active suicidal ideation with plan or recent suicide attempt
- History of moderate to severe traumatic brain injury or other neurocognitive disorders
- Inadequate understanding of English
- Currently pregnant, breastfeeding, or planning pregnancy within 12 months without contraception
- Presence of metal in the body or pacemaker contraindicating MRI
- Epilepsy, neuromuscular disorders, or tardive dyskinesia
- Chronic infectious illness
- Immediate need for psychiatric hospitalization
- Medications contraindicating study drugs
- Recent or ongoing somatic treatments like vagus nerve stimulation or electroconvulsive therapy
- Allergy or contraindication to ibuprofen
- Symptoms of chronic fatigue syndrome or long-COVID
- Use of medications or supplements for weight or appetite control
- Autoimmune disorders like ulcerative colitis or Crohn's disease except treated hypothyroidism
- Physical activity restrictions preventing intense exercise
- Use of beta-blockers, calcium channel blockers, or heart-modulating medications
- Significant abnormalities on EKG
- Hypertension, hepatitis, renal dysfunction, or anemia posing risk
- Moderate or heavy smoking
- Resting heart rate over 100 bpm or blood pressure over specified limits
- Clinically significant abnormal lab results
- Any other reasons making study participation unsafe
AI-Screening
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Trial Site Locations
Total: 1 location
1
Laureate Institute for Brain Research
Tulsa, Oklahoma, United States, 74136
Actively Recruiting
Research Team
J
Jonathan Savitz
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
BASIC_SCIENCE
Number of Arms
4
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