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 @ 1:08 AM
Ignite Modification Date:
2025-12-25 @ 1:08 AM
NCT ID:
NCT04171193
Eligibility Criteria:
Inclusion Criteria:
* Patients with Treatment resistant depression on depressive state with or without psychiatric comorbidities for anxious features
* moderate to severe condition measured by Montgomery Asperger Depression Rating Scale and Hamilton Depression rating scale - 17
* be between 18 and 60 years old
* IF female, do not be pregnant and use a trustable contraceptive method
* can read and write in Portuguese language
* will to be in all the phases of the study
* have agreed with free will to participate
* classified as American Society of Anesthesiologists - Physical Status 1 or 2 by a certified anesthesiologist
* Suicide ideation measured by Montgomery Asperger Depression Rating Scale on item 10 less than 4
Exclusion Criteria:
* drug abusers in the last 6 months, except for nicotine
* use of benzodiazepines or lamotrigine less then 15 days from the first session
* family history of malignant hyperthermia Suicidal ideation on item 10 of Montgomery Asperger Depression Rating Scale more than 4
* Suicide attempt one month prior the study begins
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT04171193
Study Brief:
Protocol Section:
NCT04171193