Open Label Ketamine Treatment for Major Depressive Disorder in Veterans

Completed · Phase 2

Conditions studied: Major Depressive Disorder

In brief

Medically healthy Veterans ages 21-75 that have been diagnosed with Depression will get up to 6 treatments of Ketamine infusions, weekly. After treatment is completed, follow up will occur at 1 month, 3 months, and 6 months after completion of infusions to evaluate the longer term effects of ketamine.

Key facts

Study ID

NCT03053830

Run by

VA Connecticut Healthcare System

People needed

11

Starts

2017-01-31

Expected to finish

2018-09-26

Last updated by the study team

2023-09-18

Who can join

Age: 21 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

• VA Healthcare System — West Haven, Connecticut, United States

Full record on ClinicalTrials.gov

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