Health TrialsbyHealthPanel

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

ConditionBipolar 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

This trial does not accept healthy volunteers

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

Design model

Crossover

Treatments tested in this trial

  • Exercise Session

    Other intervention

    30 min cycling on bicycle ergometer at 60% peak power output

  • Ibuprofen 800 mg

    Drug

    A single oral dose of Ibuprofen

  • Rest

    Other intervention

    Resting for 30 min in chair

  • Placebo

    Drug

    Matched placebo

Treatment groups

20 Participants
are divided into 4 treatment groups
Group A: Session 1Experimental treatment 2 interventions
Group B: Session 2Active comparator 2 interventions
Group C: Session 3Active comparator 2 interventions
Group D: Session 4Placebo comparator 2 interventions

Trial outcomes

Primary outcomes

1

Inflammation

Serum concentrations of interleukin 6 (IL-6)

Time frame
Difference between IL-6 at baseline and two hours post intervention
2

Neural Response to Reward Anticipation

Percent Signal Change in Ventral Striatum During Monetary Incentive Delay

Time frame
One hour post intervention

Secondary outcomes

1

Neural Response to Reward Receipt

Percent Signal Change in Ventral Striatum During Monetary Incentive Delay (MID) task

Time frame
One hour post intervention
2

Brain Volume

Gray Matter Volume of the Hippocampus

Time frame
One hour post intervention
3

Inflammation

Serum concentrations of tumor necrosis factor (TNF)

Time frame
Difference between TNF at baseline and two hours post intervention
4

Inflammation

Serum concentrations of interleukin 10 (IL-10)

Time frame
Difference between IL-10 at baseline and two hours post intervention

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Laureate Institute for Brain Research, Inc.

Lead sponsor

Source ClinicalTrials.gov
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