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
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the short-term antidepressant effects of acute exercise in adults with bipolar depression. This randomized, triple-blind, crossover trial involves 20 participants aged 18 to 55 years who have a current major depressive episode and meet specific diagnostic criteria. The study aims to investigate how exercise affects symptoms, immunity, and brain function, and whether blocking inflammation with ibuprofen changes these effects. Participants will take part in four sessions combining exercise or rest with either 800 mg of ibuprofen or a placebo. Exercise sessions involve 30 minutes of cycling on a bicycle ergometer at 60% peak power output, while rest sessions consist of 30 minutes sitting in a chair. The order of these sessions is counterbalanced, allowing comparison of the effects of exercise and ibuprofen on mood and neural responses. During the study, participants will undergo behavioral testing, magnetic resonance imaging (MRI), and blood draws to assess inflammation markers and brain activity related to reward processing. Researchers will measure changes in inflammatory proteins (such as IL-6, TNF, and IL-10), brain volume, and symptoms of anhedonia using standardized scales. Safety and adherence will be monitored throughout the study, which lasts long enough to complete all four experimental sessions.
CONDITIONS
Brief 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 form
- Established residence and phone
- Eligible for behavioral testing, MRI, and blood draws
- Willingness to comply with study procedures and availability for study duration
- Male or female aged 18 to 55 years
- DSM-V diagnosis of bipolar disorder
- Current major depressive episode
- Depression severity score greater than 11 on the QIDS
- Stable medication use for at least 4 weeks (some non-medicated may be included)
- Body mass index between 18.5 and 35
You will not qualify if you...
- Diagnosis of other major psychiatric disorders like schizophrenia or psychotic depression
- History of bipolar disorder with rapid cycling
- Severe manic symptoms posing risk of manic episode (YMRS score over 19)
- Moderate or severe drug, alcohol, or substance use disorder (except nicotine) within specified timeframes
- Taking more than 4 mood-related psychotropic medications daily
- Use of medications interacting with ibuprofen or immune-modulating drugs or regular NSAIDs use
- Current or prior cardiac disease or arrhythmia
- Unstable medical conditions including significant respiratory disease, liver disease, or hypothyroidism not stabilized for 3 months
- Claustrophobia preventing MRI participation
- Active suicidal ideation with plan or recent suicide attempt
- History of moderate to severe traumatic brain injury or other neurocognitive disorders
- Inadequate English understanding
- Pregnancy, breastfeeding, or planning pregnancy without contraception
- Metal in body or pacemaker contraindicating MRI
- Epilepsy, neuromuscular disorder, or tardive dyskinesia
- Chronic infectious illness
- Immediate hospitalization need for psychiatric disorder
- Medications contraindicating study drugs
- Recent somatic treatments like electroconvulsive therapy
- Allergy or contraindication to ibuprofen
- Symptoms of chronic fatigue syndrome or long-COVID
- Use of weight or appetite control medications or supplements
- Autoimmune disorders except treated hypothyroidism
- Physical activity restrictions limiting intense exercise
- Use of heart-modulating medications like beta-blockers
- Abnormal EKG findings
- Severe hypertension, hepatitis, renal dysfunction, or anemia
- Moderate or heavy smoking
- Resting heart rate over 100 bpm or high blood pressure
- Significant abnormal lab results
- Any other condition making participation hazardous
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 4 sessions completed over several weeks
Participants undergo four sessions in a randomized crossover design: exercise with ibuprofen, exercise with placebo, rest with ibuprofen, and rest with placebo.
4 visits (in-person) for each session
Duration - Up to 2 hours after each session
Participants are monitored for changes in inflammation and neural responses up to two hours after each session.
Assessments during each treatment visit
Trial Site Locations
Total: 1 location
1
Laureate Institute for Brain Research
Tulsa, Oklahoma, United States, 74136
Actively Recruiting
Research Team
J
Jonathan Savitz
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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