Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:31 AM
Ignite Modification Date:
2025-12-25 @ 1:31 AM
NCT ID:
NCT05604794
Eligibility Criteria:
Inclusion Criteria:
* Written informed consent
* Over the age of 18
* Should be psychologically and medically cleared by a psychiatrist, family physician, or treatment team
* Diagnosed with Major Depressive Disorder (MDD), Bipolar Depression, Generalized Anxiety Disorder, Obsessive Compulsive Disorder (OCD), and Eating Disorder by a licensed healthcare practitioner (including Field Trip Consultants)
* A significant history of trauma and/or formal diagnosis of PTSD as per the Diagnostic and Statistical Manual of Mental Disorders 5 (DSM 5)
* Individuals who have received Electroconvulsive Therapy (ECT) or other neuromodulatory treatments like Transcranial Magnetic Stimulation (TMS)
* Individuals reporting suicidal ideation may be included, as suicidal ideation is a symptom of a Major Depressive Episode (MDE)
Exclusion Criteria:
* Individuals who are unable to consent to the treatment
* Pregnant women and nursing mothers
--Note that Post Partum Depression (PPD) can be considered on a case-by-case basis in consultation with the National Medical Director.
* There is a relative (not absolute) contraindication for individuals with a Body Mass Index (BMI) of above 35. These clients must be given thorough consideration by the medical team.
* Any individual who has met DSM 5 criteria for a Substance Use Disorder in the past 3 months.
* Note that patients with alcohol, opioid, benzodiazepine, cocaine, and amphetamine use disorders need to go through detox (for alcohol/benzodiazepines) and be sober for 4 weeks.
* Note that mild active alcohol, cocaine, and cannabis use can be considered on a case-by-case basis at the comfort level of the treatment team if the client has demonstrated abstaining or significant reduction of use prior to starting treatment.
* Daily use of moderate to high doses of benzodiazepines
* Individuals who are experiencing psychotic symptoms as part of an MDE (mood congruent/ mood incongruent)
* Psychosis: Schizophrenia, Schizoaffective disorder, Bipolar 1 with psychotic features during mania
* Active Mania: Bipolar 1 (chronic non-disruptive hypomania is an exception at the discretion of the consultant)
* Borderline Personality Disorder
* Uncontrolled medical disorders
* Physical conditions with negative interaction with ketamine (e.g., metabolic blood disorder)
* Individuals with symptomatic acute brain injury within 90 days of serious injury
* Individuals diagnosed with moderate to severe sleep apnea
* Individuals who are unable to identify a person or service to assure their safe transport to home post treatment
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
19 Years
Study:
NCT05604794
Study Brief:
Protocol Section:
NCT05604794