Phase 2 Bipolar Disorder Trial, Recruiting

Written by an AI model from 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 diagnosed with Bipolar I Disorder (BD1) who are between 18 and 65 years old and in reasonably good general physical health, as assessed by the trial doctor
• People whose BD1 symptoms are currently stable — meaning mood rating scale scores fall within specific low ranges — and who have not had a significant worsening of low-level depression in the four weeks before joining
• People who are not showing signs of being on the verge of a manic or depressive episode, as assessed using standard rating tools
• People who have no history of a suicide attempt, no high-level suicidal thoughts in the past year, and no suicidal thoughts of any kind in the past month
• People who have been on a stable, clinically acceptable mood-stabilising medication for more than 30 days before screening, with no medication changes planned during the study — or people with untreated BD1 who the trial doctor considers stable enough to participate
• People who are able to understand and follow instructions throughout the study, as assessed by the trial doctor
• People who are willing to follow all study procedures and restrictions, including staying at the clinical research centre as required by the study schedule
• People of any gender, race, or ethnicity
• People who are able to understand and sign a written consent form
• Males (whether or not they have had a vasectomy) who agree to use barrier contraception (such as a condom) throughout the study until after a specific follow-up visit
• Females who either cannot become pregnant (due to surgical sterilisation such as hysterectomy, removal of both ovaries, or tubal ligation, or because they have been postmenopausal for at least one year) — or females who can become pregnant and agree to use an acceptable contraceptive method throughout the study and for at least 30 days after the last dose (confirm specific contraceptive options with trial site)
• People who can communicate in English, including speaking, reading, and writing
• People with a body weight of at least 50 kg and a body mass index (BMI) between 18.0 and 31.0 kg/m²
• People whose heart tracing (ECG) does not show any clinically significant abnormalities, as assessed by the trial doctor

Who may not be able to join:

• People with significant abnormalities in physical examination, blood tests, vital signs, or heart tracing (ECG) that could affect safety or the ability to complete the study
• People with a history of serious drug allergy, asthma (except childhood asthma), severe hives, or other severe allergic conditions
• People with any other medical or psychiatric condition (besides BD1) that might prevent successful completion of the study
• People with any other severe medical, psychiatric, or social circumstance that could increase the risk of participating or interfere with study results, as judged by the trial doctor
• People with a history of seizure disorder or severe head injury (a single childhood fever-related seizure may be an exception — confirm with trial site)
• People with a history or current presence of stomach or digestive conditions such as chronic gastritis, peptic ulcers, inflammatory bowel disease, or related conditions
• People with a history or current presence of acute or chronic liver disease
• People with any surgical or medical condition that could affect how the body absorbs, processes, or removes the study medications
• People with a history of frequent headaches or migraines
• People with kidney disease where kidney function falls below a specific threshold (confirm with trial site)
• People with uncontrolled heart rhythm problems, atrial fibrillation, or heart failure
• People with active cancer (except certain minor skin cancers) currently requiring chemotherapy or radiation therapy
• People who test positive for HIV, Hepatitis B, or Hepatitis C at screening (with some exceptions — confirm with trial site)
• People with severe liver failure (a specific medical classification — confirm with trial site)
• People with uncontrolled high blood pressure above a specific level at screening or check-in
• People with a fever, active upper respiratory infection, or any other active infection at screening or check-in
• People with psychiatric or neurological conditions other than BD1 — for example, schizophrenia, Parkinson's disease, seizure disorders, or myasthenia gravis
• People currently being treated with certain medications including haloperidol, monoamine oxidase inhibitors (MAOIs), or neuromuscular blocking agents, or who have had long-term immunosuppressant treatment (confirm specifics with trial site)
• People on lithium treatment who have low sodium levels in their blood
• People regularly using any medication, supplement, or over-the-counter product within 14 days before screening — with specific exceptions including hormonal contraceptives, paracetamol (acetaminophen), low-dose aspirin for heart protection, and stable mood-stabilising medications (confirm exceptions with trial site)
• People who have received electroconvulsive therapy (ECT) within the 6 months before screening
• People who are unwilling to avoid poppy seeds or quinine (including tonic water) for 48 hours before check-in and throughout the study
• People with aspirin/nasal polyp/asthma syndrome
• Females who are currently breastfeeding
• Females who are pregnant at screening or at check-in, or who plan to become pregnant during the study
• People with a history of allergic or sensitivity reaction to lithium, aspirin, salicylates, L-proline, or any ingredient in the study medications
• People with a history of drug abuse (including certain substances — confirm list with trial site) within the last 12 months, or a positive drug test at screening or check-in
• People with a history of problematic alcohol use, or a positive alcohol test at screening or check-in, or who regularly drink more than a moderate amount of alcohol
• People who regularly consume more than five cups of coffee (or equivalent) per day, or who are unwilling to avoid caffeine-containing products for 48 hours before check-in through to discharge after the second treatment period
• People who are unwilling to avoid grapefruit, pomelo, or Seville orange products for 14 days before check-in through to discharge after the second treatment period
• People who have participated in another clinical trial or received an experimental medication within 30 days (or longer, depending on the medication) before the first dose in this study
• People with untreated thyroid dysfunction
• People whose MRI scan shows certain brain findings, or who have implanted medical devices that are not MRI-compatible, or who are unable to tolerate MRI procedures
• People with any past suicide attempt or suicidal behaviour, including a lifetime history of suicide attempts, high-level suicidal thoughts in the past year, or any suicidal thoughts in the past month
• People suspected of having or considered at risk for Brugada Syndrome (a specific heart condition — confirm with trial site)
• People with certain untreated brain or nervous system conditions — such as untreated underactive thyroid or vitamin B12 deficiency at specific levels — that could affect thinking or brain health, as judged by the trial doctor

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