Phase 3 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:

For people with Bipolar Disorder (Patient Group):

• People aged 18 to 75 years old, male or female
• People who have been diagnosed with Bipolar Disorder type I or type II
• People currently experiencing a depressive episode that has not responded to treatment, lasting at least 2 weeks but no longer than 52 weeks, with depression scores meeting a specific threshold as measured by a rating scale (confirm with trial site)
• People who have already tried at least one other treatment for their current depressive episode without success
• Women who could become pregnant must be using an accepted form of contraception, such as abstinence, the oral contraceptive pill, a surgically implanted contraceptive device, an intrauterine device (IUD), a condom with spermicidal foam or jelly, or tubal ligation
• People currently taking a mood-stabilising medication, specifically lithium, valproate, lamotrigine, or quetiapine at a dose of 100mg per day or less
• People whose blood test results, including blood cell counts, iron stores, electrolytes, thyroid, kidney, blood sugar, cholesterol, and hormone levels, are all within normal ranges at screening
• People with a normal heart tracing (ECG) at screening
• People who are able to give their informed consent to participate

For people without any psychiatric history (Control Group):

• People aged 18 to 75 years old, male or female
• People with no current or past history of any psychiatric condition
• Women who could become pregnant must be using an accepted form of contraception, as listed above
• People whose blood test results are all within normal ranges at screening
• People with a normal heart tracing (ECG) at screening
• People who are able to give their informed consent to participate

Who may not be able to join:

For people with Bipolar Disorder (Patient Group):

• People considered to be at high risk of suicide, based on their score on a clinical rating scale or in the opinion of the treating doctor
• People currently experiencing a hypomanic or manic episode, based on a clinical rating scale score (confirm with trial site)
• People experiencing psychotic symptoms, based on a clinical rating scale score or in the opinion of the treating doctor
• People currently taking the medications fluoxetine or carbamazepine
• People currently taking risperidone, olanzapine, quetiapine at doses above 100mg per day, ziprasidone, or any other antipsychotic medication
• Women who are pregnant or breastfeeding, or women who could become pregnant and are not using contraception
• People with a current or recent problem with drug misuse or dependence, as assessed by a standard diagnostic interview
• People with an unstable medical condition
• People with another unstable or untreated psychiatric condition, a brain disorder, or an untreated medical condition such as thyroid problems, diabetes, a heart condition, or high blood pressure
• People with low levels of vitamin B12 or folate
• People whose mood cycles rapidly, meaning more than four mood episodes per year
• People with a current or past history of difficulty swallowing
• People with seizures that are not currently controlled with medication
• People who experience a significant drop in blood pressure when standing up (a drop of at least 20mmHg in the upper blood pressure number or 10mmHg in the lower number within 3 minutes of standing)
• People with a significant history of heart or cardiovascular disease, or irregular heart rhythms
• People with a low white blood cell count
• People with a known eye disease
• People with involuntary, irregular muscle movements, particularly in the face
• People with a known allergy or sensitivity to brexpiprazole or any of its ingredients
• People with lactose intolerance, hereditary galactose intolerance, or glucose-galactose malabsorption, because the trial tablets contain lactose
• People with an active inflammatory condition such as lupus, colitis, Crohn's disease, psoriasis, or irritable bowel syndrome (IBS)
• People with a mild or major neurocognitive disorder (a condition affecting thinking, memory, or reasoning)
• People with a known history of sensitivity or poor tolerance to certain types of medications processed by specific liver enzymes (CYP 2D6 or CYP 3A4) (confirm with trial site)

For people without any psychiatric history (Control Group):

• People with alcohol or drug misuse problems
• People with low levels of vitamin B12 or folate
• People with seizures not currently controlled with medication
• People with a significant history of heart or cardiovascular disease, or irregular heart rhythms
• People with a mild or major neurocognitive disorder

For anyone taking part in the MRI scan component:

• People with a pacemaker
• People with a heart or vascular surgical clip
• People with a metal prosthesis
• People with metal fragments anywhere in the body
• People using a transdermal (skin) patch
• People with an aneurysm clip
• People with a prosthetic heart valve
• People who experience claustrophobia (fear of enclosed spaces)
• Women who are pregnant

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