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 who have been diagnosed with Bipolar I disorder and are currently going through a depressive episode (without psychosis or mixed features), as confirmed by a structured clinical interview
• People whose current depressive episode started at least 4 weeks ago but no more than 18 months before joining the trial
• People who are currently receiving care as an outpatient (not in a hospital)
• People whose depression is rated as moderately severe or above on two standard assessment scales at both an initial screening visit and a baseline visit, with scores remaining fairly consistent between those visits
• People whose mood (manic) symptoms are low, as measured by a standard rating scale at both screening and baseline visits
• People who are in good general physical health
• People with a body mass index (a measure of body weight relative to height) between 18 and 40
• People whose diagnosis, symptom severity, and treatment history have been independently confirmed through a centralised review process
• People who have a stable living situation and are willing to sign a consent form approved by an ethics review board

Who may not be able to join:

• Women who are able to become pregnant and are sexually active but are not using two different forms of birth control, men who are not using two different forms of birth control, or women who are currently breastfeeding
• People who have previously tried two or more adequate medication treatments for depression without improvement
• People whose depression scores improve by 20% or more between the screening and baseline visits
• People whose bipolar disorder involves mixed features (depression and mania at the same time) or who experience very frequent mood episodes (rapid cycling)
• People who plan to start formal talk therapy or structured psychological treatment during the study
• People who have a psychiatric diagnosis other than bipolar disorder that has been active within the 12 months before screening
• People who are experiencing hallucinations, delusions, or other psychotic symptoms in their current depressive episode that are linked to a condition other than bipolar disorder
• People who were hospitalised for a manic episode within 30 days before screening, or whose most recent manic episode has not fully resolved
• People assessed by the trial doctor as having a significant risk of suicidal behaviour during the study
• People with an underactive or overactive thyroid gland
• People with insulin-dependent diabetes
• People with uncontrolled high blood pressure
• People with significant known heart disease
• People whose blood test results fall outside the ranges defined in the trial protocol
• People with significantly abnormal heart tracing (ECG) results
• People who have received electroconvulsive therapy (ECT) within 90 days before screening
• People who have received transcranial magnetic stimulation (a brain stimulation treatment) within 90 days before screening
• People who are currently taking medications that are not permitted under the trial protocol
• People who have only ever responded to ketamine, ECT, or vagus nerve stimulation, or who have not responded to any of these treatments
• People who have received a GLP-1 medication (a type of drug sometimes used for diabetes or weight management) within 30 days before screening
• People with a history of organ disease that the principal investigator considers would make participation unsuitable

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