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:

• You have been diagnosed with Major Depressive Disorder (MDD), and your current depressive episode has lasted more than 6 weeks but no longer than 18 months.
• Your anxiety symptoms are mild to moderate or below, based on a standard anxiety rating scale score of 22 or under.
• Your depression is rated as moderate to severe on a standard depression scale, both at your first screening visit and at the start of the study.
• You have been consistently taking a single antidepressant (specifically an SSRI or SNRI type) for at least 6 weeks for your current episode, at an appropriate dose, but it has not worked well enough — and your dose must have been stable for the past 4 weeks with no changes planned during the study.

Who may not be able to join:

• You have ever been diagnosed with schizophrenia, psychosis, bipolar disorder, cyclothymic disorder, delirium, dementia, or other cognitive or memory disorders.
• You currently have, or have had active symptoms in the last 2 years of, OCD (obsessive-compulsive disorder), PTSD, panic disorder, or an eating disorder.
• Your primary diagnosis is a specific personality disorder (such as borderline, antisocial, paranoid, schizoid, schizotypal, or histrionic), or you have a current history or history within the last 2 years of self-harm behaviour.
• During your current depressive episode, you have already tried and not responded adequately to more than 2 different SSRI or SNRI antidepressants (including the one you are currently taking).
• You have previously tried thyroid hormone supplements (T3 or T4) as a treatment to boost the effect of antidepressants and they did not work.
• You started a new type of talking therapy (psychotherapy), or significantly changed how often you attend therapy, within the past 8 weeks before screening.
• You are considered to be at risk of suicide at the time of screening or at the start of the study.
• You have had a serious or uncontrolled medical condition in the past 3 months — such as a significant neurological, digestive, breathing, kidney, liver, immune, or blood disorder, or cancer — that could make participation unsafe (confirm with trial site).
• You have any history of thyroid disease.
• You have any history of a condition called multiple endocrine neoplasia syndrome.
• You have epilepsy, a history of seizures or convulsions (including childhood febrile seizures), or you currently take any medications known to lower the seizure threshold.
• You are currently pregnant, planning to become pregnant, or are breastfeeding.
• You have previously used psychedelics, ketamine, or esketamine to treat your depression.
• You are currently using, or have used within the past 4 weeks, any other medications added to boost your antidepressant's effect — such as antipsychotics, MAOIs, tricyclic antidepressants, lithium, or bupropion.
• You are currently taking or have previously taken any thyroid hormone treatment, including synthetic or natural thyroid supplements.
• You are taking biotin (a vitamin/supplement) in any dose or form within 14 days before the study starts and through to the final visit at Week 8.
• You are currently taking any medications classified as strong inhibitors or strong inducers of a liver enzyme called CYP3A4 (confirm with trial site which medications apply).
• You have misused prescription drugs, controlled substances, or illegal drugs within the past year, or you test positive for illegal substances at your screening or baseline visit.
• You have a history of, or currently have, cataracts, glaucoma, inflammatory eye disease, or have had eye surgery or laser eye treatment in either eye.

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