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 65 of any gender
• People with a confirmed primary diagnosis of major depressive disorder (as assessed using a structured clinical interview called the MINI)
• People currently experiencing a moderate-to-severe depressive episode, without psychotic features, that has lasted at least 2 months
• People whose self-rated depression questionnaire score (QIDS) is above 10
• People who have tried at least 2 antidepressant medications and/or talking therapies in the past without enough benefit, with at least one of those tried during the current depressive episode
• People who are willing to follow all study procedures and not make changes to their psychiatric treatments for the duration of the study
• People of reproductive potential who have a negative pregnancy test or have been using highly effective contraception for at least 1 month before the study starts, and who agree to continue using it throughout the study
• People who are able to understand and agree to take part, and who sign and date a consent form
• People who are currently under the care of a licensed psychiatrist, mental health provider, or addiction medicine specialist, and who agree to inform the study team if that provider changes
• People who agree to allow the study team to communicate with any healthcare provider who has cared for them within the past two years, for the purposes of confirming eligibility or responding to any safety concerns
• People who can provide the name and contact details of at least two people aged 22 or older who live within a 60-minute drive of their home, and who agree that the research team may contact those people if a safety concern arises and the participant cannot be reached

Who may not be able to join:

• People with a history of serious brain injury or a neurological disorder
• People with a general medical condition that is not well managed
• People who are pregnant or breastfeeding
• People who have an implanted device in the head or neck
• People who are unable to tolerate or have a medical reason not to have an MRI scan
• People who have received brain stimulation treatments such as ECT, TMS, or VNS in the past month
• People who have had a change in their antidepressant treatment in the past month
• People assessed as being at moderate-to-high risk of suicide based on a standardised rating scale, or in the clinical judgement of the study psychiatrist
• People who have engaged in suicidal behaviour in the past year
• People who have made a serious suicide attempt at any point in their lifetime
• People with a moderate-to-severe substance use disorder in the past 3 months
• People whose primary diagnosis is obsessive compulsive disorder (in the past month)
• People whose primary diagnosis is post-traumatic stress disorder (in the past month)
• People with a bipolar-spectrum disorder at any point in their lifetime
• People with a schizophrenia-spectrum disorder at any point in their lifetime
• People with a neurocognitive disorder diagnosed in the past year
• People with a severe personality disorder
• People the study team considers clinically unsuitable for participation for any reason

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