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Bipolar DepressionPhase 1/2NCT06088732

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

A Phase 1/2 study testing Exercise Session, Ibuprofen 800 mg and Rest in people with Bipolar Depression, run by Laureate Institute for Brain Research, Inc. at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 55 years
Conditions the study is for
Bipolar Depression
What is being tested?
Exercise Session, Ibuprofen 800 mg and Rest
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
20 participants
Where
1 siteUnited States
Study dates
12 Mar 2024to 31 Dec 2026
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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
  • Males and females; Age 18-55 years
  • DSM-V diagnosis of bipolar disorder
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  • Has a current major depressive episode
  • Depression at enrollment of sufficient severity to score > 11 on the QIDS
  • 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)
  • BMI between 18.5 and 35

Who cannot join

  • 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)
  • 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)
  • 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)
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  • Current or prior cardiac disease, cardiac arrhythmia (e.g. supraventricular tachycardia, atrial fibrillation, ventricular fibrillation), or history of cardiac ablation therapy
  • 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).
  • History of claustrophobia that would prevent participation in imaging scans
  • 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
  • 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
  • Inadequate understanding of English
  • Currently pregnant or breast-feeding; fecund women not using adequate contraceptive methods; plan to become pregnant within 12 months
  • 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
  • Has epilepsy, a neuromuscular disorder, or tardive dyskinesia
  • Has a chronic infectious illness
  • Requires immediate hospitalization for psychiatric disorder
  • Requires medications for a general medical condition that contraindicate any study medication
  • Receiving or have received during the index episode vagus nerve stimulation, electroconvulsive therapy, transcranial magnetic stimulation, or other somatic treatments
  • Allergy to, or other medical contraindication to ibuprofen (e.g. stomach ulcers)
  • Symptoms of myalgic encephalomyelitis/chronic fatigue syndrome or "long-COVID".
  • Current use of medications or dietary supplements for weight or appetite control, whether prescribed or not
  • Ulcerative colitis, Crohn's disease or other autoimmune disorder (except treated hypothyroidism)
  • Activity restrictions that limit the subject's ability to engage in intense physical activity
  • Use of beta-blockers, calcium channel inhibitors, or other heart-modulating medications (e.g., amiodarone)
  • Clinically significant abnormality on EKG
  • Hypertension, hepatitis, renal dysfunction, and/or anemia of sufficient severity to pose a risk to the participant
  • Moderate or heavy smoker based on Fagerstrom
  • Resting heart rate >100 beats per minute, systolic blood pressure > 160 mmHg, diastolic blood pressure > 100 mmHg
  • Clinically significant screening laboratory abnormalities not covered above
  • Any reason not listed herein that would make participation in the study hazardous

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Jonathan Savitz contact

9185025104

jsavitz@laureateinstitute.org

United States1 site, 1 recruiting

  • Laureate Institute for Brain Research

    Tulsa, Oklahoma, 74136

    Jonathan Savitz, PhD, 918-502-5104, jsavitz@laureateinstitute.org

    Recruiting

Other trials in United States

About this study

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.

Being tested
Exercise Session, Ibuprofen 800 mg, Rest, Placebo
Medical subject headings
Bipolar Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Exercise SessionOther

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

  • Ibuprofen 800 mgDrug

    A single oral dose of Ibuprofen

  • RestOther

    Resting for 30 min in chair

  • PlaceboDrug

    Matched placebo

Study groups in NCT06088732
Study groupRoleWhat they receive
Session 1ExperimentalExercise (30 min on bicycle ergometer at 60% peak power output) and a single oral dose 800mg of ibuprofen
Receives: Other: Exercise Session; Drug: Ibuprofen 800 mg
Session 2Active comparatorExercise (30 min on bicycle ergometer at 60% peak power output) and matching placebo
Receives: Other: Exercise Session; Drug: Placebo
Session 3Active comparator30 minutes rest (sitting in chair) and a single oral dose 800mg of ibuprofen
Receives: Drug: Ibuprofen 800 mg; Other: Rest
Session 4Placebo comparator30 minutes rest (sitting in chair) and matching placebo
Receives: Other: Rest; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Inflammation

    Serum concentrations of interleukin 6 (IL-6)

    Measured: 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

    Measured: One hour post intervention

Secondary outcomes (5)

  1. Neural Response to Reward Receipt

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

    Measured: One hour post intervention

  2. Brain Volume

    Gray Matter Volume of the Hippocampus

    Measured: One hour post intervention

  3. Inflammation

    Serum concentrations of tumor necrosis factor (TNF)

    Measured: Difference between TNF at baseline and two hours post intervention

  4. Inflammation

    Serum concentrations of interleukin 10 (IL-10)

    Measured: Difference between IL-10 at baseline and two hours post intervention

  5. Anhedonia

    Score on the Snaith-Hamilton Pleasure Scale (SHAPS). Higher scores indicate greater anhedonia. Score range from 0-14.

    Measured: Difference between SHAPS scores at baseline and two hours post intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Oct 2023
  2. Study start12 Mar 2024
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Crossover
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06088732
Sponsor's protocol ID
2023-001
Status last verified
May 2025
First submitted
12 Oct 2023
Last updated
23 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Exercise Session, Ibuprofen 800 mg and Rest in people with Bipolar Depression, run by Laureate Institute for Brain Research, Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 23 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jonathan Savitz (9185025104, jsavitz@laureateinstitute.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Inflammation (time frame: Difference between IL-6 at baseline and two hours post intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06088732.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2025.

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