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

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-55
SponsorLaureate Institute for Brain Research, Inc.

About this trial

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 criteria

Qualifiers

Provision of signed and dated informed consent form

Has an established residence and phone

Agrees to and is eligible for behavioral testing, magnetic resonance imaging, and blood draws.

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

Disqualifiers

Diagnosis of any other major psychiatric disorder such as schizoaffective disorder, schizophrenia, or current psychotic depression

A history of bipolar disorder with rapid cycling

Concurrent manic symptoms of sufficient severity to pose a substantial risk of the development of a manic episode (>19 on the YMRS)

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)

Trial design

Treatments tested in this trial

  • Exercise Session
  • Ibuprofen 800 mg
  • Rest
  • Placebo

Treatment groups

20 Participants
are divided into 4 treatment groups