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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up difference between shaps scores at baseline and two hours post intervention

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ one hour post intervention

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Neural Response to Reward Anticipation

Secondary outcome measures

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

~1040

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Laureate Institute for Brain Research, Inc.Lead Sponsor

50 Previous Clinical Trials

5,325 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this investigation including individuals aged 65 and above?

"The cut-off points for this medical trial stipulate that the minimum age of participation is 18, while 55 is the upper limit."

Answered by AI

Am I eligible to partake in this medical research?

"This clinical trial is recruiting individuals who are aged between 18 and 55, have been diagnosed with depression or bipolar disorder, and will accept around 20 participants."

Answered by AI

Is the enrollment period still open for this experiment?

"According to the clinicaltrials.gov platform, recruitment for this trial has been halted since October 12th 2023. Despite its current inactive status, there are still 1488 other medical studies actively seeking participants."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2024. "Effects of Acute Exercise and Ibuprofen on Symptoms, Immunity, and Neural Circuits in Bipolar Depression". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06088732.