Open Label Ketamine Treatment for Major... — Clinical Trial Details

Open-label, single-group treatment trial of up to six IV ketamine infusions (0.5 mg/kg over 40 minutes) given once or twice weekly to Veterans with major depressive disorder; follow-up at 1, 3 and 6 months.

Primary objectives are to assess safety and tolerability in this population and to examine longer-term clinical effects; all participants continue usual standard care during the trial.

1. Male or female, 21-75 years old
2. Current major depressive disorder without psychotic features by DSM-5
3. Montgomery-Åsberg Depression Rating Scale (MADRS) ≥ 20
4. Able to provide written informed consent

1. Current or past history of psychotic features or psychotic disorder
2. Current or past history of delirium or dementia
3. Current uncontrolled hypertension (systolic BP > 170 mm Hg or diastolic BP > 100 mm Hg)
4. Unstable medical condition or allergy to ketamine or lorazepam — clinically determined by a physician
5. Pregnant or nursing women, positive pregnancy test, or inadequate birth control methods in women of childbearing potential
6. Positive opioid or illicit drug screen test (except marijuana)

Company

Product

Legal

Open Label Ketamine Treatment for Major Depressive Disorder in Veterans

Detailed Description

Study Protocol

Preparation

Dosing

Locations

Integration

Study Arms & Interventions

Ketamine infusions

Interventions

Participants

Inclusion Criteria

Exclusion Criteria

Study Details

Study Team

Sponsors & Collaborators