Phase 4 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:

• Adults between 18 and 65 years old (both male and female)
• People who are able to understand what the study involves, follow the study procedures throughout, and agree in writing to take part
• People currently experiencing a major depressive episode linked to major depressive disorder (MDD), bipolar I disorder (BD-I), or bipolar II disorder (BD-II), confirmed through a structured diagnostic interview (certain prior interview results from related studies may also be accepted — confirm with trial site)
• People whose depression symptoms score above a certain level on a standardised clinician rating scale (QIDS-C16 score greater than 10)
• People who are able to travel to the trial site for assessment visits
• People who can become pregnant must have a negative urine pregnancy test at the start of the study
• People who can become pregnant must be using an accepted form of contraception during the study, such as hormonal contraception, an intrauterine device (IUD), tubal ligation, a partner's documented vasectomy, or complete abstinence — barrier methods such as condoms are only acceptable when used alongside one of these primary methods
• People with BD-I must already be taking at least one mood-stabilising medication (such as lithium, valproate, or a mood-stabilising antipsychotic) at a stable dose for at least one month before joining
• People with BD-II who are already taking a mood stabiliser (such as lithium, valproate, or lamotrigine) must have been on a stable dose of that medication for at least one month before joining

Who may not be able to join:

• People who are not able to understand and communicate in English
• People who are unable to give free and voluntary written consent — for example, those under conservatorship, guardianship, a legal commitment order, or currently in involuntary psychiatric hospitalisation
• People who score below 75% on a short quiz (4 questions) about the study's goals, risks, and benefits
• People with BD-I who have not been using at least one mood stabiliser at a stable and therapeutically effective dose for at least one month
• People whose depression has not responded to two or more adequate antidepressant or mood-stabilising treatments during the current episode (sometimes called treatment-refractory depression)
• People with active suicidal thoughts, as measured by specific scores on two standardised rating tools (MADRS item 10 and C-SSRS items 4 and 5) — confirm thresholds with trial site
• People who have made a medically serious suicide attempt in the past 6 months — meaning one that required an emergency department visit, a medical procedure, or a hospital admission
• People currently taking, or who have taken within the past 14 days, a class of antidepressant medications called monoamine oxidase inhibitors (MAOIs)
• People showing a significant mix of depressive and manic symptoms at the same time, as measured by a specific rating scale score (YMRS score of 12 or higher)
• People currently taking either of the study medications (vortioxetine or cariprazine) at the time of enrolment — prior use is acceptable
• People who have previously had an allergic reaction to any of the study medications, or for whom the study medications have already been tried at the highest therapeutic dose without benefit
• People with a history of seizure disorder (epilepsy)
• People who have taken certain longer-acting psychiatric medications recently — specifically fluoxetine or long-acting injectable antipsychotics — within the past 4 weeks
• People currently experiencing active psychosis, or who have a diagnosis of schizophrenia, schizoaffective disorder, delusional disorder, or schizophreniform disorder
• People with a current diagnosis of drug or alcohol use disorder (not including nicotine); at least 3 months of full remission is required
• People whose urine drug test is positive for illicit substances such as cocaine, methamphetamine, or illegal opiates — people who use cannabis may still be considered if they complete a cannabis use screening tool and score 12 or below (confirm with trial site)
• People who are pregnant, breastfeeding, trying to become pregnant, or not using adequate contraception
• People with an active or unstable medical condition that the lead doctor considers to carry too much risk for safe participation
• People with significantly abnormal lab results, uncontrolled high blood pressure (above 160/100 mmHg), or a resting heart rate above 110 beats per minute
• People with significant kidney, liver, or heart disease; cancer; autoimmune disease; or chronic kidney disease beyond a certain level of severity (estimated GFR below 60 mL/min/1.73 m²)
• People with a history of traumatic brain injury involving loss of consciousness for 5 minutes or more
• People who have had a Roux-en-Y gastric bypass surgery
• People with a current clinical diagnosis of delirium, encephalopathy, intellectual disability, or a cognitive disorder (mild or major)
• People currently receiving electroconvulsive therapy (ECT), transcranial magnetic stimulation (TMS), vagus nerve stimulation (VNS), or deep brain stimulation (DBS)
• People currently taking systemic steroids, chemotherapy, or radiotherapy
• People taking high daily doses of benzodiazepine medications above specified thresholds — for example, lorazepam above 4 mg/day, or equivalent doses of similar medications (confirm equivalents with trial site)
• People without access to a smartphone or the internet
• People whose primary reason for seeking treatment is another diagnosed psychiatric condition that significantly shapes their current symptoms, as assessed by clinical judgement
• People currently being treated with opioid agonist therapy (such as methadone or buprenorphine for opioid dependence)

Additional exclusions apply for the second phase of the study (involving the medication cariprazine as an add-on treatment):

• People whose depression symptoms have already reached remission by that stage, based on a specific rating scale score (MADRS of 10 or below)
• People taking certain medications that strongly affect how the body processes cariprazine — including some antifungals, antibiotics, or herbal supplements such as St. John's Wort (confirm full list with trial site)
• People with BD-I who are currently taking an antipsychotic medication as their mood stabiliser

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