Phase 1 PTSD Trial, Recruiting

Written by an AI model from the 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 are right-handed, as measured by a standard handedness questionnaire
• People who are currently experiencing depression, shown by a score above 17 on a standard depression rating scale
• People whose depression has not improved after trying at least one antidepressant medication at an adequate dose
• People who have previously received ketamine and experienced a reduction in their depressive symptoms (prior ketamine non-responders would not be eligible)
• People who meet the standard clinical diagnosis for Major Depressive Disorder (MDD), confirmed through a structured interview
• People who are already engaged in some form of mental health treatment outside of this study (those not currently in treatment may be referred to one before joining)
• People who are taking antidepressant medication and have been on the same medication and dose for at least 4 weeks before joining, with a plan to continue that same treatment throughout the trial
• People who are receiving talk therapy and have been doing so for at least 4 weeks before joining, with a plan to continue throughout the trial
• People who are willing to avoid caffeine, alcohol, and recreational drugs for one week before each MRI session
• Women who are not pregnant or breastfeeding and who agree to use an accepted form of contraception (such as the pill, implant, condom, diaphragm with spermicide, IUD, abstinence, or a partner who has had a vasectomy); women who have had surgical sterilisation or have gone through menopause (with no period for at least one year) are not required to use contraception
• Women who are able to receive ketamine during the first week of their menstrual cycle where possible, and consistently during the same phase of their cycle for each scan
• People who are able to read and write in English
• People who have completed at least a Year 12 level of education or the equivalent

Who may not be able to join:

• People who score in the "intent" or "intent with plan" categories on a standard suicide risk scale, or who are assessed by the study doctors as being at serious risk of suicide
• People who have a neurological condition, except for migraine headaches or mild head injuries (note: people with migraines would not be able to attend a ketamine visit within 24 hours of a migraine); head injuries considered more than mild include: being unconscious for more than 30 minutes after an injury, memory loss lasting more than one hour after an injury, concussion symptoms lasting more than one week, concussion symptoms in the first week after injury that caused more than one day of being unable to carry out normal activities, or four or more concussive events of any severity
• People who are currently receiving ketamine as part of their regular treatment
• People who are currently taking the medications topiramate, memantine, or barbiturates within two weeks of joining the trial
• People who use benzodiazepine medications during the daytime
• People who have taken monoamine oxidase inhibitor (MAOI) medications within 4 weeks of joining the trial
• People who have received treatment with a vagal nerve stimulator, electroconvulsive therapy (ECT), or deep brain stimulation within two weeks of joining the trial
• People who experience psychosis that is not directly related to a depressed mood during a depressive episode
• People with insulin-dependent diabetes, or poorly controlled non-insulin-dependent diabetes
• People with other significant medical conditions, unless a study doctor has reviewed and cleared their participation
• People with a history of violent behaviour, unless the study doctors determine there are specific circumstances that make participation safe (for example, if the violence was always related to past substance use and the person has maintained stable sobriety)
• People who have met the criteria for a substance use disorder or alcohol use disorder in the three months before screening (those with mild alcohol use disorder involving only 2–3 symptoms may be considered at the investigators' discretion)
• People who return a positive result on a urine drug screening test before scans, or on a breathalyser test, unless the study doctors decide otherwise
• People whose heart tracing (ECG) shows clinically significant abnormalities as assessed by a doctor
• People with abnormal results on blood or chemistry tests at the initial medical screening, unless a study doctor determines the findings do not add risk
• People with a known history of HIV or Hepatitis B
• People who have taken prescription or over-the-counter medications or herbal supplements that act on the brain within one week before the MRI scan (some exceptions may be made if the study investigators determine the substance will not affect the study or safety)
• People with a known sensitivity or allergic reaction to ketamine or heparin
• People whose resting blood pressure is below 85/55 or above 140/90, or whose resting heart rate is below 45 or above 100 beats per minute, unless cleared by a study doctor
• People with a history of general intellectual disability
• People with a history of claustrophobia (fear of enclosed spaces)
• People with significant uncorrectable problems with colour vision or eyesight that cannot be addressed with the equipment available in the scanner
• People who have a cardiac pacemaker, other electronic implanted devices, or metal objects in vulnerable areas of the body, as identified through a standard MRI safety screening questionnaire
• People who have donated more than 500 mL of blood, or experienced a similar significant blood loss, within 56 days before receiving the study drug
• Participation may also be declined at the discretion of the principal study doctors or study physician

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