Phase 2 Bipolar Disorder Trial, Recruiting

Written by an AI model from the ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People aged 18 to 55 years, of any gender
• People who have been diagnosed with bipolar disorder according to standard diagnostic criteria (DSM-V)
• People who are currently experiencing a major depressive episode
• People whose depression is severe enough to score above 11 on a standard depression questionnaire called the QIDS
• People who have been on stable psychiatric medication for at least 4 weeks (or people not on medication, if the trial doctor considers this appropriate)
• People with a BMI between 18.5 and 35
• People who have a permanent home address and a working phone
• People willing and able to take part in behavioural testing, MRI scans, and blood draws
• People willing to follow all study procedures and lifestyle requirements for the full duration of the trial
• People who have signed and dated a consent form agreeing to take part

Who may not be able to join:

• People diagnosed with another major psychiatric condition, such as schizophrenia, schizoaffective disorder, or psychotic depression
• People with a history of rapid-cycling bipolar disorder
• People currently experiencing manic symptoms severe enough to suggest a manic episode may be developing (scoring above 19 on the YMRS scale)
• People with a current moderate or severe drug, alcohol, or substance use disorder (within the past 6 months for severe cases, or 2 months for moderate cases), not including nicotine
• People currently taking more than 4 mood-related psychiatric medications daily
• People taking medications that interact significantly with ibuprofen, immune-modifying medications (such as oral steroids), or people who use anti-inflammatory painkillers (NSAIDs) more than 3 times per week
• People with a current or past heart condition, irregular heart rhythm, or a history of cardiac ablation procedures
• People with an unstable medical condition, including serious breathing conditions (such as asthma or COPD), liver disease, thyroid conditions not yet stable for 3 months, cancer, or any condition likely to require hospitalisation or with a life expectancy under 6 months
• People with a history of claustrophobia that would prevent them from completing MRI scans
• People who are actively suicidal with a plan and intent, who are developing suicidal thoughts requiring immediate treatment, or who have made a suicide attempt in the past 6 months
• People with a history of moderate to severe traumatic brain injury (involving more than 30 minutes of unconsciousness or more than 24 hours of memory loss), or any other neurological condition with measurable brain or nerve deficits
• People who do not have adequate understanding of English
• People who are currently pregnant or breastfeeding; people capable of becoming pregnant who are not using adequate contraception; or people planning to become pregnant within 12 months
• People with metal implants in their body or a pacemaker, which would make MRI scans unsafe
• People with epilepsy, a neuromuscular disorder, or tardive dyskinesia (an involuntary movement condition)
• People with a chronic infectious illness
• People who need immediate hospitalisation for a psychiatric condition
• People who require medications for another medical condition that would conflict with the study medications
• People who have received treatments such as vagus nerve stimulation, electroconvulsive therapy (ECT), transcranial magnetic stimulation, or similar brain-based treatments during the current episode of illness
• People with a known allergy or medical reason not to take ibuprofen (such as stomach ulcers)
• People currently experiencing symptoms consistent with chronic fatigue syndrome (ME/CFS) or long COVID
• People currently using any prescribed or non-prescribed medications or supplements for weight loss or appetite control
• People with ulcerative colitis, Crohn's disease, or other autoimmune conditions (except treated hypothyroidism)
• People with physical restrictions that prevent them from taking part in intense physical activity
• People taking beta-blockers, calcium channel blockers, or other medications that affect heart function (such as amiodarone)
• People with a clinically significant abnormality on a heart tracing (EKG)
• People with high blood pressure, hepatitis, kidney problems, or anaemia severe enough to pose a health risk
• People who are moderate or heavy smokers, based on a standard smoking assessment (Fagerstrom scale)
• People with a resting heart rate above 100 beats per minute, or blood pressure above 160/100 mmHg
• People with significant abnormal results on screening blood tests not covered by the above criteria
• People where participation in the study would be considered hazardous for any other reason

Important: Always verify eligibility with the trial site directly before applying.