Phase 1 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 have been formally diagnosed with Major Depressive Disorder (MDD) or Bipolar Disorder (Type I or II) using a structured clinical interview.
• People between 18 and 65 years of age.
• People whose depression scores are rated as severe on standard clinical measurement scales (a score of at least 21 on either the HDRS first 17 items or the MADRS scale).
• People whose ability to carry out daily life activities is significantly affected, as measured by a standard disability scale (WHODAS 2.0 score of 19 or more).
• People whose depression has either returned 4 or more times, or has lasted continuously for 2 or more years, AND where the first depressive episode began at least 5 years ago — and whose illness has caused major problems in daily functioning, repeated hospitalisations, or serious self-harm over their lifetime, as determined by a study investigator.
• People whose depression has not responded to multiple treatments, as determined by the study psychiatrist — specifically, people who have tried: at least 3 different classes of antidepressant medications (each for 6 or more weeks at an adequate dose); at least 2 different add-on or combination medications used alongside an antidepressant (each for 4 or more weeks at an adequate dose); an adequate course of electroconvulsive therapy (ECT) — meaning more than 6 bilateral treatments — or who were medically unable to tolerate ECT; and at least 20 sessions of individual psychotherapy with an experienced therapist.
• People who are able to follow the study's procedures and administrative requirements.
• People who are able to give written informed consent.
• People for whom MDD or Bipolar Disorder is considered the main psychiatric diagnosis, in the medical opinion of a study investigator.
• People who have been on a stable psychiatric medication regimen for at least 6 weeks before enrolling, and who are expected to continue that regimen through the first 6 months of the study, as determined by the investigator.
• People who can provide contact details for at least two people who know them well and live within 10 miles of them, including name, relationship, address, and phone number.
• People who agree to allow the study team to request and receive their medical records from any healthcare provider seen in the past 5 years.
• People who agree to continue seeing a licensed psychiatrist or mental health professional on a regular basis throughout the study.
• People aged 18–21 who score an average of at least 3 across specific sections of a psychological maturity assessment (covering ego resilience, self-awareness, autonomy, and flexibility) (confirm with trial site).
• People aged 18–21 who are living with a caretaker or have oversight from a caretaker.

Who may not be able to join:

• People with any history of psychosis or a psychotic disorder, according to DSM-5 criteria or in the medical opinion of the study psychiatrist.
• People whose pre-surgery MRI scan shows findings that, in the opinion of the study team, could increase medical risk, affect the ability to complete the study, or affect the reliability of results.
• People who have previously had surgery that destroyed the specific brain pathway being targeted in this trial (the superolateral medial forebrain bundle), making it unable to be stimulated, as seen on MRI.
• People for whom brain stimulation surgery (DBS) is medically unsuitable — including those with a cardiac pacemaker, implantable defibrillator or other implanted stimulator, pregnancy, metal in the body, severe claustrophobia, active infection, blood clotting problems, inability to be awake during the procedure, or significant heart or other medical risks for surgery.
• People who refused an adequate trial of ECT without a medical reason acceptable to the study psychiatrist or investigator.
• People who have previously not been able to tolerate stimulation of any kind applied to the body.
• People who have been diagnosed with a substance use disorder in the 6 months before enrolling.
• Women who could become pregnant and, at enrolment or during the study: have a positive pregnancy test; are sexually active with a male partner without using a highly effective contraceptive method (such as tubal ligation, a vasectomised partner, an IUD, or long-acting reversible contraception); or are planning to become pregnant during the 60-month study period.
• People with active thoughts of suicide with intent, a suicide attempt in the last 6 months, more than 3 suicide attempts in the last 2 years, or serious suicide risk as assessed by the study psychiatrists.
• People who have participated in another drug, device, or biological treatment trial in the past 30 days.
• People with a medical condition that requires regular MRI scans.
• People with a medical condition that requires diathermy (a type of heat-based medical treatment).
• People currently taking blood-thinning (anticoagulant) medication.
• People who, in the opinion of the study investigator, have a medical, psychiatric, physical, or personal situation that could put them at significant risk, make it unlikely they could complete all study requirements, or could affect the reliability of the study results.
• People who do not have a fixed home address or stable living situation, in the opinion of the study investigator.
• People who have been involved in activities with significant radiation exposure in the past year.
• People who would receive TMS (transcranial magnetic stimulation) after having the DBS device implanted.
• People who have experienced a manic episode within 5 years of enrolling, according to DSM-5 criteria or in the medical opinion of the study psychiatrist.

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