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 @ 2:37 AM
Ignite Modification Date:
2025-12-25 @ 2:37 AM
NCT ID:
NCT07099534
Eligibility Criteria:
Inclusion Criteria:
* Adult patient aged 18 to 65 years
* Fluent in French
* Person affiliated with or receiving social security benefits.
* Diagnosis of borderline personality disorder established according to the DSM-5 MINI criteria (5 out of 9 criteria)
* Severe borderline personality disorder
* Patient receiving stable pharmacological (antipsychotic, mood stabilizer, antidepressant) and/or non-pharmacological (schema therapy, DBT) treatment for four weeks
Exclusion Criteria:
* Personal history of an acute psychotic episode or chronic psychotic disorder
* Personal history of a manic or hypomanic episode
* Family history (first-degree relatives) of a psychotic disorder
* Current severe depressive episode
* Recreational ketamine use (multi-weekly ketamine use)
* New long-term treatment introduced within the previous four weeks (antidepressant, antipsychotic, mood stabilizer)
* Prescription of an Monoamine oxidase inhibitors (increased risk of hypertension)
* Specific absolute contraindication to ketamine
* History of cirrhosis or major liver function test abnormalities
* Major ECG abnormality
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT07099534
Study Brief:
Protocol Section:
NCT07099534