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Behavioural Intervention

Exercise + Ibuprofen for Bipolar Depression

Phase 1 & 2
Recruiting
Research Sponsored by Laureate Institute for Brain Research, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Depression at enrollment of sufficient severity to score > 11 on the QIDS
Has a current major depressive episode
Must not have
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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up difference between shaps scores at baseline and two hours post intervention

Summary

This trial tests if exercise helps bipolar depression, plus if blocking the body's inflammation response affects exercise's effects.

Who is the study for?
This trial is for adults aged 18-55 with bipolar depression, a BMI of 18.5-35, and who are stable on medication or deemed appropriate to participate. They must be able to undergo behavioral testing, MRI scans, and blood draws. Exclusions include severe substance abuse, complex psychiatric medication regimens, significant heart conditions or unstable medical issues, pregnancy or breastfeeding without contraception use, metal in the body that affects MRI safety, suicidal tendencies recently or certain medications like NSAIDs.
What is being tested?
The study tests if acute exercise can alleviate symptoms of bipolar depression by comparing four sessions: two involving exercise and two rest periods. Before these activities participants take either ibuprofen (800mg) or placebo to see if blocking inflammation affects the benefits of exercise on mood and brain function.
What are the potential side effects?
Possible side effects from ibuprofen may include stomach upset or ulcers, kidney problems, increased risk of heart attack or stroke especially after prolonged use at high doses; however specific side effects will be monitored given its single-dose administration in this study.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My depression is severe, scoring over 11 on the QIDS.
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I am currently experiencing a major depressive episode.
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I am between 18 and 55 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have or had heart disease, irregular heartbeats, or underwent a procedure to correct heart rhythm.
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My health is stable and I don't have severe asthma, COPD, liver disease, or poorly controlled hypothyroidism.
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I have metal in my body or a pacemaker, making MRI scans unsafe for me.
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I take medication that cannot be mixed with the study drugs.
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I am allergic to or cannot take ibuprofen due to medical reasons like stomach ulcers.
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I am experiencing severe mood swings that could lead to a manic episode.
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I am not on medications that interact with ibuprofen, immune drugs, or taking NSAIDs regularly.
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I have been diagnosed with a major psychiatric disorder like schizophrenia.
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I have a long-term infectious disease.
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I have undergone treatments like vagus nerve stimulation or electroconvulsive therapy.
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I do not have autoimmune disorders except for treated hypothyroidism.
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I need to be hospitalized immediately for a mental health issue.
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I have been diagnosed with rapid cycling bipolar disorder.
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I have epilepsy, a neuromuscular disorder, or tardive dyskinesia.
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I am currently using weight or appetite control medications or supplements.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~one hour post intervention
This trial's timeline: 3 weeks for screening, Varies for treatment, and one hour post intervention for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Neural Response to Reward Anticipation
Secondary study objectives
Anhedonia
Brain Volume
Inflammation
+1 more

Trial Design

4Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Session 1Experimental Treatment2 Interventions
Exercise (30 min on bicycle ergometer at 60% peak power output) and a single oral dose 800mg of ibuprofen
Group II: Session 3Active Control2 Interventions
30 minutes rest (sitting in chair) and a single oral dose 800mg of ibuprofen
Group III: Session 2Active Control2 Interventions
Exercise (30 min on bicycle ergometer at 60% peak power output) and matching placebo
Group IV: Session 4Placebo Group2 Interventions
30 minutes rest (sitting in chair) and matching placebo
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ibuprofen 800 mg
2007
Completed Phase 4
~1030

Find a Location

Who is running the clinical trial?

Laureate Institute for Brain Research, Inc.Lead Sponsor
52 Previous Clinical Trials
5,420 Total Patients Enrolled
~12 spots leftby Dec 2025
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