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 given their signed agreement to participate in the study.
• People who have been voluntarily admitted to a psychiatric ward around the time of the initial screening appointment.
• People aged between 18 and 65 years old on the day of their screening appointment.
• People who have been diagnosed with a depressive episode as part of Bipolar Disorder Type I or Type II, confirmed using a standard psychiatric interview tool.
• People whose depression symptoms score at or above a certain level on a standard depression rating scale (confirm with trial site).
• People who have been taking a mood-stabilising medication at a stable dose for at least 4 weeks before screening — this includes lithium, lamotrigine, valproate, or carbamazepine, each at specific minimum levels or doses (confirm exact requirements with trial site).
• Women who could become pregnant must have a negative pregnancy test and must be using a highly effective form of contraception — such as sterilisation, hormone implants, hormone injections, certain intrauterine devices, or a partner who has had a vasectomy.
• Men must agree to use condoms throughout the study and for 2 weeks after the last dose of the study medication, unless their partner is already using a highly effective form of contraception as described above.

Who may not be able to join:

• People who are currently under involuntary or compulsory psychiatric care.
• People the investigator considers to be at immediate risk of harm to themselves, others, or property.
• People who have previously been diagnosed with, or who are found at interview to meet the criteria for, obsessive-compulsive disorder or post-traumatic stress disorder.
• People with a previous diagnosis of a personality disorder, autism, ADHD, or intellectual disability.
• People who have had a problem with substance or alcohol misuse within the 2 years before screening.
• People with any other diagnosed or suspected condition affecting the brain or nervous system — such as dementia, brain injury, or epilepsy — that the investigator considers makes participation unsuitable.
• People whose score on a standard mania rating scale is above a certain level at screening or at any point during the trial (confirm with trial site).
• People with any physical health condition that the investigator considers makes participation unsuitable.
• People whose physical health checks — including vital signs, physical examination, blood tests, or heart tracing (ECG) — show results that the investigator considers raise safety concerns, including a specific heart rhythm measurement that exceeds set limits for men and women.
• People who the investigator believes are unlikely to follow the study instructions, attend appointments, or stick to the treatment plan.
• People who have had any change in their antidepressant or mood-stabiliser medication (including dose changes) within 4 weeks before screening, or at any point during the trial.
• People currently taking certain medications that strongly affect how the body processes other drugs — a group known as potent cytochrome P450 enzyme inhibitors, which includes some antifungals, antibiotics, and other specific drugs (confirm full list with trial site).
• People currently taking certain medications that have a narrow safe dosing range — such as blood thinners, some heart medications, some anti-seizure drugs (when used for epilepsy), or immune-suppressing drugs — where small changes in drug levels could be harmful.
• People currently taking medications that work primarily on dopamine pathways in the brain, such as antipsychotics, certain stimulants, or Parkinson's disease medications.
• People whose symptoms are not improving with treatment and whose condition is severe enough that the investigator considers it would be unethical for them to continue in the trial.
• People who have previously taken the study drug OSU6162.
• People who are currently taking part in another clinical trial.
• Women who are currently breastfeeding.

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