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:

• Adults between 18 and 65 years old (the trial has specific targets for the proportion of men and women, and for different ethnic backgrounds, to reflect the population most affected by this condition)
• People who have received a formal diagnosis of Major Depressive Disorder (a serious form of depression), confirmed through a structured interview and review by a specialist psychiatrist
• People whose depression has not improved despite trying two or more antidepressant medications with different mechanisms, an evidence-based talking therapy, a medication added to boost antidepressant treatment (such as lithium, certain antipsychotics, or a thyroid hormone), or electroconvulsive therapy (ECT) — or where ECT was considered but not tolerated or not effective
• People with at least moderate depression symptoms, as measured by a standard rating scale (a score of 20 or above on the MADRS) at the screening appointment
• People whose current treatments — including any medications and therapy — have been stable for at least six weeks before joining
• People who speak fluent English and are able to read and sign a written consent form
• People who agree that if something unexpected is found during brain imaging (such as an incidental finding), this may be noted and acted upon

Who may not be able to join:

• People with a clinical history of a neurocognitive condition caused by a degenerative brain disease (such as early dementia)
• People whose self-reported cognitive function falls below a certain threshold on a standardised scale, as measured at the baseline appointment (confirm with trial site)
• People with a history of significant structural brain conditions, including Parkinson's disease, multiple sclerosis, or a brain tumour
• People with uncontrolled diabetes (shown by a fasting blood sugar of 120 mg/dL or above, or a certain blood marker called HbA1c at 6.5% or above) or uncontrolled high blood pressure (two consecutive readings of 140/90 mmHg or above), as measured at the baseline appointment
• People who are currently pregnant or breastfeeding
• People who test positive for alcohol or certain drugs (including methadone, opiates, cocaine, amphetamines, or ecstasy), or who have had more than a mild substance use disorder involving alcohol, stimulants, sedatives, or cannabis in the past six months
• People who are currently experiencing active thoughts of suicide at a serious level, as measured by a standardised safety assessment, or who have made a suicide attempt in the past three months — as assessed at the baseline appointment
• People for whom an MRI scan is not safe or not possible (for example, due to metal implants), or who are unwilling or unable to complete MRI scans
• People with a history of moderate to severe traumatic brain injury, specifically a loss of consciousness lasting more than five minutes, or a skull fracture
• People currently diagnosed with a psychotic disorder (such as schizophrenia), bipolar disorder, an eating disorder (such as anorexia or bulimia), a learning disability, or a personality disorder that the trial investigators consider would make it difficult to follow the study procedures
• People with a history of moderate or severe alcohol or substance use disorder, as defined by standard diagnostic criteria
• People who have taken benzodiazepines (a type of anti-anxiety or sedative medication) or anticonvulsants (medications used for seizures or mood) within the seven days before screening
• People with any medical, psychiatric, or other condition that would affect their ability to understand the study information, give informed consent, follow study procedures, or complete the trial
• People who do not have reliable access to the internet or a phone, as communication during the study is required
• People currently prescribed a medication at a dose outside the range considered appropriate by current clinical standards (confirm with trial site)
• People who are unwilling or unable to complete the main components of the study
• People with vision or hearing difficulties that cannot be corrected

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