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:

• People aged 19 to 70 years old (inclusive), of any sex.
• People who have been diagnosed with Bipolar I or Bipolar II disorder and are currently experiencing a major depressive episode, confirmed by a structured clinical interview.
• People who are currently taking a mood-stabilising medication (such as lithium or valproate), or an atypical antipsychotic medication, or a combination of these, at doses that fall within the therapeutic ranges specified by the trial.
• People who have already tried at least one recommended first-line (or second-line, for Bipolar II) treatment for bipolar depression at an adequate dose for a minimum of 6 weeks during their current depressive episode.
• People whose depression symptom score (measured by a standard scale called the MADRS) is 20 or higher, and whose mania symptom score (measured by a scale called the YMRS) is 12 or lower.
• People who are receiving care either as a hospital inpatient or as an outpatient.
• People who agree to use highly effective contraception (such as hormonal contraceptives, an intrauterine device, vasectomy, tubal ligation, or double barrier methods) or to completely abstain from heterosexual intercourse during the trial. Women without the ability to become pregnant must have been postmenopausal for at least 1 year (confirmed by a blood test) or have had a surgical procedure that prevents pregnancy.
• People who are able to understand the study, give informed consent, and follow the study requirements.
• People whose other medications have been at a stable dose for at least two weeks before the start of the trial.

Who may not be able to join:

• People whose current depressive episode has lasted longer than 12 months.
• People with a history of "rapid cycling," meaning four or more mood episodes in the past 12 months.
• People with an unstable or poorly managed medical condition (other than the current depression).
• People who have recently started a recommended bipolar depression treatment but have not yet taken it at an adequate dose for at least 6 weeks.
• People who began a structured form of psychotherapy (such as cognitive-behavioural therapy or interpersonal therapy) within the past 8 weeks.
• People who started taking a stimulant medication within the past 8 weeks (stimulants are acceptable if the dose has been stable for at least 8 weeks and is prescribed by a doctor).
• People who are currently taking clozapine, tricyclic antidepressants, monoamine oxidase inhibitors (MAOIs), or older ("first-generation") antipsychotic medications.
• People who have previously not responded to, or could not tolerate, CBD (cannabidiol).
• People who currently use or have used CBD daily in the past month, or any product containing CBD (occasional users may still be considered if they agree to stop using CBD for the duration of the trial).
• People who did not respond to electroconvulsive therapy (ECT) during the current depressive episode.
• People who have another primary psychiatric condition that a study investigator determines is causing greater impairment than their bipolar disorder.
• People with a lifetime history of a primary psychotic disorder (such as schizoaffective disorder) according to standard diagnostic criteria.
• People who have met the criteria for a substance use disorder (other than nicotine or caffeine) within the past 6 months.
• People with significant active thoughts of suicide, as indicated by a score of 4 or higher on the suicide-related question of the MADRS scale.
• People who are pregnant or breastfeeding.
• People whose liver function test results are more than three times the upper limit of the normal range.

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