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:
2025-12-24 @ 2:32 PM
Ignite Modification Date:
2025-12-24 @ 2:32 PM
NCT ID:
NCT06752759
Eligibility Criteria:
Inclusion Criteria:
* All individuals 18 years and older within the Institution's inpatient Psychiatry Unit with a Montgomery-Asberg Depression Rating Scale score ≥ 20
* Must have a diagnosis of moderate to severe Major Depressive Disorder
* Structured Clinical Interview for DSM-5 (SCID-5) will be performed to confirm MDD diagnosis
Exclusion Criteria:
* Adult patients with an allergy to ketamine
* Adult patients with an allergy to Midazolam
* Individuals with a history of mania/hypomania or diagnosis of of bipolar disorder
* Patients on lithium and/or lamotrigine therapy
* Recent or current homicidal ideation with an intent to act
* MDD with psychotic features or current or past diagnosis of a psychotic disorder
* No substance use disorder in the preceding 3 months except nicotine or caffeine or a positive urine screen for substances (except cannabis)
* Diagnosis of obsessive-compulsive disorder, antisocial personality disorder, borderline personality disorder, posttraumatic stress disorder, intellectual disability, altered mental status, pregnant or breastfeeding patients,
* Patients on \> 2 medications for hypertension
* Patients with uncontrolled hypertension (BP \>140 mm Hg systolic and/or \>90 mm Hg diastolic on two separate readings at the time of screening)
* Body weight of \> 150kg
* Patients with history of congestive cardiac failure
* Day of presentation, patients with unstable vital signs (systolic blood pressure \<90 or\>160 mm Hg, pulse rate \<50 or \>150 beats/min, and respiration rate \<10 or \>30 breaths/min)
* Consumption of opioids within 24 hours of drug administration
* Acutely intoxicated patients will also be excluded
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
88 Years
Study:
NCT06752759
Study Brief:
Protocol Section:
NCT06752759