Phase 3 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 who are able to understand and agree to participate in the study on their own (have capacity to give informed consent)
• People who are currently being seen as outpatients (not admitted to hospital)
• People who have a diagnosis of bipolar disorder (type I or II) with a current depressive episode, confirmed using a structured psychiatric interview during the TRIBE trial
• People who are older than 18 years of age
• People who did not improve enough during the TRIBE study — specifically, those whose depression scores did not reduce by 50% or more over 6 weeks
• People whose depression rating score (PHQ-9) was 10 or higher both at the 6-week point in the TRIBE trial and again at the screening visit for this trial
• People who are joining within 3 months of finishing the TRIBE study
• People who are not currently in a mixed or manic episode (confirmed by a mood rating scale score)
• People who have not had a new or increased psychiatric medication started to treat depression in the 4 weeks before screening (certain sleep medications are exceptions — confirm with trial site)
• People who are currently taking one of the following mood-stabilising medications: lithium, quetiapine, asenapine, aripiprazole, paliperidone (at a dose above 6mg), risperidone, olanzapine, ziprasidone, haloperidol, or clozapine
• People who are able to follow the treatment schedule as required by the trial
• People who pass a standard safety questionnaire used before magnetic brain stimulation (TMS) treatment

Who may not be able to join:

• People who have had a diagnosis of a substance use disorder (other than nicotine or caffeine) within the last 3 months
• People who have a serious unstable physical health condition
• People who are currently experiencing active thoughts of suicide with intent to act
• People who are pregnant or planning to become pregnant during the study
• People who have ever been diagnosed with schizophrenia or schizoaffective disorder
• People who are experiencing psychotic symptoms during their current episode
• People who have an anxiety disorder, trauma-related disorder, obsessive compulsive disorder, or personality disorder that a study investigator considers to be the main condition causing the most difficulty — more so than the bipolar depression
• People who have already tried a full course of electroconvulsive therapy (ECT) during the current episode without adequate improvement
• People who have a significant neurological condition (such as a recent stroke), or any history of seizures — except those caused by ECT treatment or with a clear, one-off cause (such as a childhood fever or alcohol withdrawal)
• People who have any metal implants inside or near their head (such as aneurysm clips, shunts, or stimulators) that cannot be safely removed
• People who are currently in psychotherapy that has not been stable for at least 3 months, or where changes to the frequency or focus of sessions are expected during the study
• People who have a significant abnormal result on a laboratory (blood or other) test, in the opinion of a principal investigator
• People who are currently taking lorazepam at a dose of 2mg per day or more (or an equivalent dose of a similar medication), as this may reduce how well the brain stimulation treatment works
• People who are currently taking any anticonvulsant (anti-seizure) medication, as this may reduce how well the brain stimulation treatment works
• People who stopped taking anticonvulsant medication before screening, but not long enough ago for the medication to have cleared sufficiently from the body (confirm with trial site for specific timing)
• People who have a sensory impairment — such as significant hearing loss — that cannot be corrected and would prevent them from participating in interviews
• People who were withdrawn from the TRIBE study due to safety concerns or by the decision of the principal investigator
• People who have used substances in the last 4 weeks in a way that a principal investigator considers a safety concern for undergoing magnetic brain stimulation (rTMS)

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