Phase 2 Depression and Anxiety 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 18 to 80 years old, of any gender
• People who have been diagnosed with hepatocellular carcinoma (a type of liver cancer) or cholangiocarcinoma (bile duct cancer) confirmed by tissue sample, cell sample, or in the case of liver cancer, by imaging scans
• People whose cancer has spread to other parts of the body or has advanced locally in the liver and gallbladder area
• People who have not yet received any treatment for this cancer and are planning to start a first-line treatment that includes a type of immunotherapy drug (a PD-1 or PD-L1 inhibitor)
• People who have screened positive for depression or anxiety, based on specific questionnaire scores (a PHQ-9 score of 10 or higher, or a GAD-7 score of 8 or higher)
• People who have at least one tumour that can be measured by CT or MRI scan, with the largest tumour being at least 0.5 cm across
• People with a general performance status rated 0 to 2 on the ECOG scale, meaning they are able to carry out at least some daily activities (confirm with trial site)
• People whose liver function scores reasonably well on a standard medical scoring system called the Child-Pugh scale (a score of 7 or below)
• People whose doctors expect them to survive for at least 12 weeks
• People whose blood test results meet a set of minimum thresholds for blood cells, liver function, kidney function, and protein levels (confirm specific values with trial site)
• People who are willing to take part, have signed a consent form, and are able to attend follow-up appointments

Who may not be able to join:

• People with blood clotting problems that cannot be corrected, or who have a clear tendency to bleed
• People who currently have unstable or active stomach or bowel ulcers, or active gastrointestinal bleeding
• People with serious failure of major organs, such as severe heart or lung problems
• People who have hepatic encephalopathy (a brain condition caused by liver failure) or difficult-to-control fluid build-up in the abdomen that requires treatment
• People with a history of certain mental health conditions, including bipolar disorder, schizophrenia, or who are currently experiencing active thoughts of suicide
• People with an active hepatitis B or hepatitis C infection with a high viral load, or people who test positive for these viruses but are unwilling to receive standard antiviral treatment
• People who are unable to swallow oral (by mouth) medication
• People who have a known allergy to fluoxetine (the study medication being investigated)
• People who are currently taking other medications that may interact seriously with fluoxetine
• People whom the research team has assessed as unable or unwilling to follow the requirements of the study

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