Adults 18 to 75, any sex, with Treatment-resistant Depression. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Score After 12 Days of TreatmentPrimary· 13 days
Average difference in the Montgomery-Asberg Depression Rating Scale (MADRS) score change between groups. The MADRS has 10-items which are based on mood symptoms over the past 7 days. Each items is scored 0 (normal) to 6 (severe depression) with overall score ranges from 0 (normal) to 60 (severe depression).
Group
Value
95% CI
Six Ketamine Infusions
21.0
17.2 – 24.8
Single Ketamine Infusion Preceded by 5 Midazolam Infusions
17.2
13.2 – 21.2
Antidepressant Response Defined as >50% Decrease in MADRS Baseline ScoreSecondary· 13 days
Comparing the number of subjects that achieve response between groups as defined above.
Group
Value
95% CI
Six Ketamine Infusions
19
Single Ketamine Infusion Preceded by 5 Midazolam Infusions
20
Remission Defined as MADRS Score Equal or Less Than 9Secondary· 13 days
Comparing the number of subjects that achieve remission between groups as defined above
Group
Value
95% CI
Six Ketamine Infusions
12
Single Ketamine Infusion Preceded by 5 Midazolam Infusions
11
Time From Post-infusion Response to Occurrence of Relapse Defined as <50% of Baseline MADRS ScoreSecondary· 6 months
The length of time from post-infusion response until relapse (defined as \>50% of MADRS baseline score) assessed for up to 6 months.
Group
Value
95% CI
Six Ketamine Infusions
6.00
0 – 16.81
Single Ketamine Infusion Preceded by 5 Midazolam Infusions
2.00
0 – 4.92
Adverse events — posted to ClinicalTrials.gov
Time frame: The time frame of data collection was 3 years and 8 months (from April 2015 through December 2018). Each participant was assessed for up to 28 weeks..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Six Ketamine Infusions
Serious: 1/25 (4%)
Deaths: 0/25
Single Ketamine Infusion Preceded by 5 Midazolam Infusions
About one-third of depressed patients will not get better after multiple antidepressant treatments. This situation put a high burden on patients with depression due to worsening quality of life and increasing health care costs. Difficult-to-treat depression might be even worse among Veterans given that the frequency of depressive symptoms is 2 to 5 times higher than among the general US population. A breakthrough discovery happened in recent years when investigators found that one infusion from an old anesthetic named ketamine showed high efficacy and rapid antidepressant effect (sometimes within hours) but lasted only up to a week. The investigators propose to study if multiple infusions of ketamine can provide greater and longer antidepressant effects than one infusion. If that is the case, multiple infusions could be an alternative to relieve depressive symptoms that do not response to multiple antidepressant drugs.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07182032 — Ketamine in Central Sensitization
· Phase 4
· not yet recruiting
NCT06868589 — Reducing Pain With Methadone and Ketamine in Liver Transplant
· Phase 4
· active not recruiting
NCT07001605 — Erector Spinae Block Vs Ketamine-based Multimodal Analgesia Protocol in Lumber Decompressive Surgery
· NA
· completed
NCT07022821 — Comparison of Dexmedetomidine + Ketamine for Postoperative Pain in C-Section
· Phase 4
· recruiting
Other recruiting trials for Treatment-resistant Depression
Currently open trials in the same condition.
NCT05661383 — Olfactory and Brain Stimulations in Treatment-resistant Depression
· NA
· recruiting
NCT05607654 — The Mechanisms of Underlying Accelerated Repetitive Transcranial Magnetic Stimulation for Treatment-resistant Depression
· NA
· recruiting
NCT05377177 — Cortical Inhibition as a Biomarker of Response in a Comparison of Bilateral Versus Unilateral Accelerated Theta Burst St
· NA
· recruiting
NCT04680910 — Slow Wave Induction by Propofol to Eliminate Depression (SWIPED) I
· Phase 1
· active not recruiting
Other VA Office of Research and Development trials
Trials by the same sponsor.
NCT07456150 — Personalizing Veteran Pain Care: Adapting Coaching Interventions to Support Maintenance of Self-Care
· Phase 1
· not yet recruiting
NCT06746727 — The Development of a Transdiagnostic Intervention to Improve Social Functioning and Intimate Relationships Among Veteran
· NA
· not yet recruiting
NCT07362576 — Perinatal Peer Support for Veterans With Serious Mental Illness
· NA
· not yet recruiting
NCT06766331 — Integrated Care Versus Usual Care for Opioid Use Disorder and Infectious Diseases in Veterans
· NA
· not yet recruiting
NCT07397195 — ACT for Veterans With IBD and Mental Health Challenges
· NA
· not yet recruiting
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by VA Office of Research and Development
Last refreshed: 25 April 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02360280.