IV Ketamine Vs. in Esketamine for MDD TRD
In Esketamine and IV Ketamine: Multi-site Observational Study Assessing the Effectiveness and Tolerability of Two Novel Therapies for Treatment-resistant Depression.
Gustavo Vazquez
80 participants
Mar 20, 2023
OBSERVATIONAL
Conditions
Summary
The goal of this observational study is to learn about the comparative acute effects of ketamine vs esketamine in participants over the age of 18 for the treatment of their severe depression and suicidal ideations. Participants are already taking antidepressants and/or antipsychotics as part of their regular medical care for depression,
Eligibility
Inclusion Criteria1
- Adult outpatients (18-75 years old) with unipolar depression experiencing major depressive episodes as determined by the DSM5 and characterized as MDD-TRD (diagnosed with major depressive disorder as outlined by the DSM5) and experienced at least two previous failed antidepressant treatments of adequate dose and duration for the current episode
Exclusion Criteria1
- Individuals with psychosis, main diagnosis of personality disorder, uncontrolled hypertension, substance abuse, currently pregnant or breastfeeding, or who had a previous negative reaction to ketamine or esketamine, were ineligible to receive IV ketamine or IN esketamine.
Interventions
For IV ketamine treatment, ketamine is administered at 0.5mg/kg over 40 minutes. For IN esketamine treatment, esketamine is administered as a nasal spray, two sprays per nostril (56mg total) for the first treatment and three sprays per nostril (84mg) for the rest of the acute series. All treatments are administered at the academic center under the supervision of a mental health care professional. Patients are asked to come fasting at least two hours prior to treatment and to remain resting in the treatment room throughout the dosing session. Throughout each dosing session, blood pressure, oxygen levels, and onset, duration and severity of common side effects are recorded by nursing staff and/or physicians. Patients are discharged after a minimum of 30 minutes post administration, provided that the vital signs return to baseline and that the patient is calm, alert, and oriented.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06488586