Phase 3 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 who are currently experiencing a major depressive episode as part of unipolar major depression (diagnosed using standard DSM-5 criteria), are hospitalised for this episode, have a depression severity score of at least 24 on a standard rating scale, and for whom doctors have determined that starting venlafaxine (an antidepressant) is appropriate.
• People aged between 18 and 65 years old.
• People who have signed a consent form agreeing to take part freely and with full information.
• People who are enrolled in a French social security (health insurance) scheme.
• Women who are able to become pregnant and who use an effective form of contraception throughout the study (such as hormonal contraception, an intrauterine device, tubal occlusion, a vasectomised partner, or complete sexual abstinence).

Who may not be able to join:

• People whose depression has not responded to at least two different antidepressant treatments tried properly in the past (treatment-resistant depression), or whose depression includes psychotic features, or who have a psychotic disorder, bipolar disorder, or a current substance use disorder (other than tobacco use) within the past month.
• People with significant liver problems, based on blood test results above certain thresholds (confirm with trial site).
• People with severe kidney disease, where kidney filtering function is below 30ml/min as measured by a standard formula.
• People with a slow resting heart rate below 55 beats per minute.
• People for whom ketamine is medically unsuitable, including those with: an allergy to ketamine or its ingredients, a comatose state, significant central nervous system depression, Parkinson's disease, Lewy body dementia, progressive supranuclear palsy, a known or inherited heart rhythm condition affecting the QT interval, a recent heart attack, uncontrolled heart failure, a history of certain serious heart rhythm problems, low potassium levels in the blood, epilepsy, uncontrolled high blood pressure, porphyria, a history of stroke, or raised pressure inside the skull.
• People for whom venlafaxine is medically unsuitable, including those with an allergy to venlafaxine or its ingredients, certain rare inherited metabolic conditions, unstable high blood pressure, or where the treating doctor considers venlafaxine inappropriate based on past experience with the medication.
• People who have received venlafaxine or ketamine in the month before joining the study.
• People who need to continue taking another antidepressant, an MAOI, St John's Wort, or benzodiazepines, or who have recently stopped such medications in a way that could cause drug interactions (confirm with trial site).
• People with any other significant illness or medical concern that, in the opinion of the research team, could put them at risk.
• People who are pregnant, breastfeeding, or planning to become pregnant within three months of enrolling (a negative pregnancy test is required before joining).
• Adults who are under legal guardianship or a similar protective legal arrangement.
• People who are currently taking part in another interventional clinical study, or who are within a required waiting period following a previous study.
• People who do not have social insurance coverage.
• For the optional brain imaging part of the study (PET-MRI scan): people with certain metal implants, devices, or other factors that make MRI scanning unsafe, including pacemakers, cochlear implants, certain prostheses, ferromagnetic foreign bodies, claustrophobia, and various other items (the research team will conduct a detailed safety check before any scan).

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