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CompletedPhase 2

Open Label Ketamine Treatment for Major Depressive Disorder in Veterans

NCT03053830 · Ket-MDD · VA Connecticut Healthcare System

Closed to entry
Status
Not accepting participants
Phase 2
Phase
11
Target enrolment
1
Study sites
1 US states

What it is testing

Summary

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.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • Change in Montgomery-Asberg Depression Rating Scale (MADRS)

    Measured over Baseline, 40 mins after infusion, 140 mins after infusion, 240 mins after infusion

  • Change in Quick Inventory of Depressive Symptomatology-Self Report (QUIDS-SR)

    Measured over Baseline, 40 mins after infusion, 80 mins after infusion, 110 mins after infusion, 240 mins after infusion

  • Change in Hamilton Anxiety Rating Scale (HAM-A)

    Measured over Frame: Baseline, 40 mins after infusion,140 mins after infusion, 240 mins after infusion

  • Clinical Global Impression Scale

    Measured over Baseline

  • Change in Brief Psychotic Rating Scale (BPRS)

    Measured over Baseline, 40 mins after infusion, 80 mins after infusion, 110 mins after infusion, 140 mins after infusion, 240 mins after infusion

  • Change in Clinician-Administered Dissociative States Scale (CADSS)

    Measured over Baseline, 40 mins after infusion, 80 mins after infusion, 110 mins after infusion, 140 mins after infusion, 240 mins after infusion

  • Change in Visual Analog Scale (VAS) of Mood States

    Measured over Baseline, 40 mins after infusion, 80 mins after infusion, 110 mins after infusion, 140 mins after infusion, 240 mins after infusion

  • Time Line Follow Back (TLFB)

    Measured over Baseline

  • Columbia-Suicide Severity Rating Scale (C-SSRS)

    Measured over Baseline

  • Quality of life enjoyment and satisfaction survey (Q-LES-Q)

    Measured over Baseline

  • Cognition

    Measured over 140 mins after infusion

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

21 Years to 75 Years
Ages
All
Sex
Not accepted
Healthy volunteers
Inclusion Criteria: 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 Exclusion Criteria: 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)

Where

1 study site

FacilityCityRegionCountry
VA Healthcare SystemWest HavenConnecticutUnited States

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT03053830 on ClinicalTrials.gov →

Last updated in the registry 2023-09-18. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits

Substance

Recruiting in

All 2 trials from VA Connecticut Healthcare System →