Phase 2 Schizophrenia Trial, Recruiting

Written by an AI model from the 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 schizophrenia, bipolar I disorder, or major depressive disorder according to standard diagnostic guidelines (applies to groups 1 and 2 of the trial only)
• People whose condition is currently stable — meaning no recent worsening, and whose dose of antipsychotic or antidepressant medication (not including a drug called Cariprazine) has not changed for at least 4 weeks before the screening visit, and whose overall illness severity is rated as mild or less on a standard clinical scale (score of 1–4 on the CGI-S)
• People aged 18 to 64 years old
• People with a Body Mass Index (BMI) between 18.5 and 35 (a standard measure of body weight relative to height)
• People who are able to read and sign a consent form agreeing to take part
• Adults with a current diagnosis of schizophrenia who either have never taken antipsychotic medication or are currently taking antipsychotic medication (applies to group 3 of the trial only)

Who may not be able to join:

• People with schizophrenia who are currently showing significant levels of excitement, suspiciousness, hostility, uncooperativeness, or poor impulse control, as measured by a standard rating scale (confirm with trial site)
• People diagnosed with schizoaffective disorder, delirium, dementia, memory disorders, or severe personality disorders
• People who have taken part in another clinical trial or used an experimental drug within the past 3 months
• People with a current or past history of heart or blood vessel disease, including conditions affecting the brain's blood supply
• People with a history of seizures (fits) or conditions that make seizures more likely
• People currently taking certain medications known as strong or moderate CYP3A4 inhibitors, which can affect how other drugs are processed in the body (confirm specific medications with trial site)
• People currently taking certain medications known as strong or moderate CYP3A4 inducers, which can affect how other drugs are processed in the body (confirm specific medications with trial site)
• People who currently have thoughts of suicide or self-harm, have had thoughts of suicide in the past year, or have made a suicide attempt in the past 5 years
• People with a history of a sudden drop in blood pressure when standing up, or a history of fainting
• People who are currently stable on any dose of oral Cariprazine, or on a treatment added on top of another medication (applies to groups 1 and 2 only)
• People whose illness is currently rated as markedly ill to extremely ill on the standard clinical scale (CGI-S score of 5–7)
• People who have previously taken certain related medications (aripiprazole or brexipiprazole) and experienced a significant side effect called akathisia, which causes a distressing sense of inner restlessness and an urge to move
• People currently taking an antipsychotic medication called Clozapine (applies to group 3 only)

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