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 25 to 64 years old.
• People who have been diagnosed with moderate to severe Major Depressive Disorder (a serious form of depression), confirmed using standard diagnostic tools.
• People whose depression symptoms score at a certain level of severity at the start of the trial, checked again just before the treatment session to confirm this is still the case.
• People who have tried at least one antidepressant medication at a proper dose for 6 to 12 weeks during their current depressive episode, took it as prescribed at least 80% of the time, but had less than half their symptoms improve, or still have significant remaining symptoms.
• People who are medically and mentally stable enough to give informed consent and are willing to follow all study steps, including preparation sessions, a treatment session, follow-up integration sessions, and check-in appointments.
• People who could become pregnant must have a negative pregnancy test and agree to use effective contraception throughout the study.

Who may not be able to join:

• People who have bipolar disorder (type I or II), any psychotic disorder, or depression with psychotic features, or who have a close biological family member (parent, sibling, or child) with a psychotic or bipolar disorder.
• People who are considered to be at immediate risk of suicide, such as those with active thoughts of suicide with a plan or intention, a recent suicide attempt, or who in a doctor's judgment need urgent help.
• People currently taking certain antidepressants or other medications that affect serotonin levels in the brain — such as SSRIs, SNRIs, MAOIs, or similar drugs — unless those medications can be safely stopped and cleared from the body according to the trial's specific waiting period requirements.
• People taking unstable doses of antipsychotic medications, mood stabilisers, or long-acting sedative medications within the past two weeks, or who need medications that could interfere with how the treatment session is assessed.
• People who have recently started or significantly changed a talking therapy (psychotherapy) within two weeks before the baseline assessment.
• People with significant or unstable physical health conditions affecting the heart, brain, liver, or kidneys; those with a particular heart rhythm measurement (QTc) that is too long; or those with a known allergy or medical reason not to take fluoxetine or other study materials.
• People who are pregnant or breastfeeding.
• People who have had a substance use disorder (not including nicotine or caffeine) within the past three months, or who use cannabis outside of medical prescription and cannot stop for at least 72 hours before the treatment session.
• People who, in the opinion of the trial investigators, have any other condition that could make participation unsafe or interfere with the study's assessments.
• People who are unwilling or unable to stop certain medications before the trial, following a specific waiting period (for example, at least 7 days or more for most antidepressants, at least 6 weeks for fluoxetine, and at least 14 days for MAOIs).

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