Early Phase 1 PTSD 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:

• Men between the ages of 25 and 60 years old
• People who are able to give informed consent according to the study's institutional policies and take part in a 4-year follow-up program that includes assessments and device adjustments
• People whose psychiatric medication has remained unchanged for at least 2 months before the implant procedure, and who agree not to increase doses or add new medications during the first 6 months of the study unless medically necessary
• People with a medical chart diagnosis of chronic, treatment-resistant PTSD as their main psychiatric diagnosis, which is the primary cause of their distress and difficulties with work and social life
• People whose PTSD has been confirmed as the primary psychiatric diagnosis by the study psychiatrist through a clinical interview and a specific standardised assessment called the CAPS
• People who have had PTSD for at least 5 years in total, with no 6-month period of significant improvement in the 2 years before entering the study
• People whose PTSD has not responded adequately to at least 3 evidence-based treatments — including at least one medication (such as sertraline, paroxetine, fluoxetine, or venlafaxine at the highest tolerated recommended doses) and at least one trauma-focused talking therapy (such as Prolonged Exposure Therapy, Cognitive Processing Therapy, EMDR, or a similar evidence-based approach) — with each treatment lasting at least 3 months
• People who were unable to complete trauma-focused talking therapy because continuing it was judged to cause more harm than benefit (such as severe psychological distress), provided they did begin the treatment
• People who completed all evidence-based talking therapy for PTSD at least 3 months before joining the study
• People whose PTSD symptoms over the past month scored at least 47 on the CAPS-5 assessment, met the full criteria for a PTSD diagnosis, had significant scores in both the intrusive symptoms and hyperarousal symptom areas, and showed this level of severity over at least one month based on two separate measurements
• People whose PTSD has caused significant difficulties with work — such as receiving full disability compensation for PTSD for at least 2 years, scoring very low on a standard functioning assessment, or not having been in full-time work for 3 or more months in the past 5 years — or significant difficulties with social life, such as rarely leaving the home, consistently avoiding social activities as confirmed by someone close to them, or having had two or more serious interpersonal conflicts in the past year requiring outside intervention
• People who have a spouse, family member, or friend in their life who can confirm their PTSD symptoms and difficulties, take part in follow-up visits with the study psychiatrist, and report any unexpected neurological or psychiatric changes to the study team
• People who are willing to have unexpected neurological or psychiatric symptoms shared with the study psychiatrists and other clinical staff involved in the study
• People whose other medical conditions have been stable for at least 1 year (conditions requiring ongoing or repeated use of steroids or chemotherapy are not included in this criterion)

Who may not be able to join:

• People who have made a suicide attempt in the last 2 years and/or currently have a suicide plan
• People with unstable psychosis or bipolar disorder, or a significant current or ongoing risk of violence
• People whose primary psychiatric diagnosis is a condition other than PTSD, as determined by a standardised psychiatric interview called the MINI
• People who have started a new talking therapy program within the 3 months before joining the study
• People with an alcohol or substance use disorder in the last 6 months, an unstable recovery from substance use, or records suggesting that substance use may explain why previous treatments have not worked
• People with significant current neurological conditions such as epilepsy, stroke, or a movement disorder; or a history of serious head injury with loss of consciousness that caused neurological or cognitive problems, or that shows an abnormality on a brain MRI scan
• People with an uncontrolled medical condition, including uncontrolled heart or cardiovascular problems or uncontrolled diabetes
• People with uncontrolled chronic pain
• People whose score on a standard depression rating scale (the MADRS) is 28 or higher at the start of the study
• People who are currently taking the blood-thinning medication warfarin
• People whose brain MRI scan before the procedure shows a significant abnormality
• People who have had electroconvulsive therapy (ECT) in the past 6 months
• People who have a medical reason they cannot have MRI scans, or who need to have MRI scans of the body on a regular basis
• People with a compromised immune system
• People considered to be at high risk for surgery
• People who are currently seeking new or increased disability compensation for PTSD
• People who already have an implanted device in their skull or brain, such as an aneurysm clip, shunt, cochlear implant, or electrodes
• People who have previously had brain surgery
• People who have taken part in another research drug trial within 30 days before the study baseline assessment
• People with a blood vessel condition or other active process affecting the brain
• People with a condition that is associated with significant difficulties with memory or thinking (confirm with trial site)

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