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 who are inpatients or outpatients aged at least 18 up to 70 years old (for the schizophrenia group), at least 18 up to 65 years old (for the depression group), or at least 18 with no upper age limit (for the bipolar disorder group).
• People who are willing and able to sign a consent form before the study begins (a legal guardian is allowed to co-sign).
• Women who could become pregnant must be willing to use effective contraception during the trial. Men who will be taking valproate acid as part of the trial must also use effective contraception during the trial.
• People who have a confirmed diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder, major depressive disorder (without psychotic features), or bipolar depression (type I or II, currently in a depressive episode), as defined by DSM-5 and confirmed through a structured clinical interview.
• People whose current treatment has not worked well enough in the current episode, where a doctor has confirmed this using a standard rating scale, and where the treatment was given for at least 4 weeks at an appropriate dose.
• People whose doctor and themselves are planning to change their current psychiatric medication.
• People whose symptoms are at least at a moderate level of severity, as measured by specific clinical rating scales relevant to their diagnosis, and who are experiencing difficulties with daily functioning.

Who may not be able to join:

• People who are pregnant or breastfeeding.
• People who have previously tried and not responded to the specific study medication assigned to their diagnostic group (schizophrenia: clozapine; depression: esketamine nasal spray or ketamine by infusion) for at least 4 weeks at an effective dose.
• People who have a known intolerance to the key study medications relevant to their diagnostic group, or to all available medication options within their group.
• People who have a medical reason (contraindication) that prevents them from safely taking the key study medications relevant to their diagnostic group, as outlined in the official prescribing information for those medications.
• People who have taken part in another clinical trial involving an experimental drug or treatment within the 30 days before the first visit.
• People who have another significant illness or condition that, in the investigator's opinion, could put them at risk, affect the trial results, or affect their ability to take part.
• People who are experiencing active thoughts of suicide with some intention to act, or with a specific plan and intent, where the treating doctor determines it is not safe for them to participate.
• People who currently meet the criteria for a severe substance use disorder. Nicotine dependence is allowed, as is mild or moderate alcohol or cannabis use disorder, but severe alcohol or cannabis use disorder is not permitted.
• People who are under a court or government order requiring them to be in an institution.
• People who are directly dependent on the sponsor, investigator, or trial site (confirm with trial site).
• For the schizophrenia group only: people whose schizophrenia symptoms are considered to be in remission according to a specific set of clinical criteria.
• For the schizophrenia group only: people who have clinically significant abnormal results on blood tests (particularly white blood cell counts and liver function), heart tracing (ECG), or physical examination.
• For the bipolar disorder group only: people who score 12 or higher on a scale that measures manic symptoms, indicating significant manic or mixed-state symptoms.
• For the bipolar disorder group only: people with a history of mania or hypomania triggered by antidepressant medication, or a history of rapid cycling between mood states in the recent past.
• For the bipolar disorder group only: people with pre-existing severe liver damage, as identified by blood tests at the first visit.

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