RecruitingPhase 1 / Phase 2

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 55 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether a single exercise session can ease depression in adults ages 18–55 with bipolar disorder. It also tests whether ibuprofen changes exercise’s effects on mood, the brain, and the immune system. The 20 participants will each have four sessions with exercise or rest, after taking either 800 mg of ibuprofen or a placebo (a pill with no active medicine).

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be 18–55 years old and have a diagnosis of bipolar disorder.
  • Be having a major episode of depression, with a score above 11 on the QIDS depression survey.
  • Have been on a stable medicine plan for at least 4 weeks. People taking no medicine may join if the study doctor approves.
  • Have a BMI of 18.5–35. BMI is a measure of weight compared with height.
  • Have an established home and a phone.
  • Sign and date a form agreeing to join the study.
  • Be willing and able to have behavior tests, MRI scans (pictures inside the body), and blood draws.
  • Be available for the whole study and agree to follow its procedures and lifestyle rules.

Who can't join

  • Have another major mental illness, a history of rapid mood cycles, strong symptoms of mania (very high energy or mood), or need urgent mental health hospital care. Have current suicide thoughts needing urgent care, a suicide plan with intent, or a suicide attempt in the past 6 months.
  • Have a severe drug or alcohol use disorder within 6 months, or a moderate one within 2 months, except nicotine. Smoke at a moderate or heavy level on the study’s smoking test, or do not understand enough English.
  • Take more than 4 daily mood-related medicines; medicines that affect the immune system, heart, or study medicines; pain relievers called NSAIDs more than 3 times a week; or medicines or supplements for weight or appetite control. Have an ibuprofen allergy or a condition that makes it unsafe, such as stomach ulcers.
  • Have heart disease, an abnormal heart rhythm, prior treatment to destroy tissue causing an abnormal rhythm, or an abnormal heart tracing. Have a resting pulse above 100, top blood pressure above 160, bottom blood pressure above 100, or high blood pressure severe enough to pose a risk.
  • Have an unstable illness, serious breathing or liver disease, an ongoing infection, or an immune illness such as Crohn’s disease, except treated low thyroid function. Other exclusions include low thyroid function not stable for 3 months, risky kidney problems, hepatitis, anemia (too few healthy red blood cells), unsafe blood test results, or another condition making participation unsafe.
  • Have a moderate or severe brain injury, a disorder affecting thinking with nerve or brain problems, epilepsy (seizures), a nerve or muscle disorder, or tardive dyskinesia (uncontrolled movements). Have chronic fatigue syndrome or long-COVID symptoms, or restrictions that prevent intense exercise.
  • Be pregnant, breastfeeding, planning pregnancy within 12 months, or able to become pregnant without using adequate birth control. Have metal or a pacemaker that makes MRI unsafe, or fear of tight spaces that prevents scanning.
  • Have received brain or nerve stimulation or other physical treatments for the current depression episode, such as electroconvulsive therapy (ECT), transcranial magnetic stimulation (TMS), or vagus nerve stimulation.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: 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 9. Be stably medicated for at least 4 weeks (a non-medicated subject may be included in the study if judged to be appropriate in the medical/psychiatric opinion of the investigator) 10. BMI between 18.5 and 35 Exclusion Criteria: 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). 9. History of claustrophobia that would prevent participation in imaging scans 10. Actively suicidal, as defined by expressive ideation with a plan and intent for suicide or developing suicidal ideation that requires immediate medical or treatment intervention or a suicide attempt within the previous six months 11. Participants who endorse a history of moderate to severe traumatic brain injury (\>30 min. loss of consciousness or \>24 hours posttraumatic amnesia) or other neurocognitive disorder with evidence of neurological deficits 12. Inadequate understanding of English 13. Currently pregnant or breast-feeding; fecund women not using adequate contraceptive methods; plan to become pregnant within 12 months 14. Metal in the body (e.g. history of working as a sheet metal worker) or pacemaker which is a contra-indication to magnetic resonance imaging 15. Has epilepsy, a neuromuscular disorder, or tardive dyskinesia 16. Has a chronic infectious illness 17. Requires immediate hospitalization for psychiatric disorder 18. Requires medications for a general medical condition that contraindicate any study medication 19. Receiving or have received during the index episode vagus nerve stimulation, electroconvulsive therapy, transcranial magnetic stimulation, or other somatic treatments 20. Allergy to, or other medical contraindication to ibuprofen (e.g. stomach ulcers) 21. Symptoms of myalgic encephalomyelitis/chronic fatigue syndrome or "long-COVID". 22. Current use of medications or dietary supplements for weight or appetite control, whether prescribed or not 23. Ulcerative colitis, Crohn's disease or other autoimmune disorder (except treated hypothyroidism) 24. Activity restrictions that limit the subject's ability to engage in intense physical activity 25. Use of beta-blockers, calcium channel inhibitors, or other heart-modulating medications (e.g., amiodarone) 26. Clinically significant abnormality on EKG 27. Hypertension, hepatitis, renal dysfunction, and/or anemia of sufficient severity to pose a risk to the participant 28. Moderate or heavy smoker based on Fagerstrom 29. Resting heart rate \>100 beats per minute, systolic blood pressure \> 160 mmHg, diastolic blood pressure \> 100 mmHg 30. Clinically significant screening laboratory abnormalities not covered above 31. Any reason not listed herein that would make participation in the study hazardous

Study sites (1)

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