Adults 18 to 65, any sex, with Depression or Mood Disorders. 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.
MADRS Score - BaselinePrimary· Baseline
Antidepressant effects were assessed using the Montgomery-Åsberg Depression Rating Scale (MADRS). It is a ten-item diagnostic questionnaire which psychiatrists use to measure the severity of depressive episodes. Higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60.
Group
Value
95% CI
Ketamine - Healthy Volunteers
1.17
± 1.37
Placebo - Healthy Volunteers
1.48
± 1.78
Ketamine - MDD Patients
33.83
± 4.23
Placebo - MDD Patients
31.82
± 5.84
MADRS Score - Day 1 Following InterventionPrimary· Day 1
Antidepressant effects were assessed using the Montgomery-Åsberg Depression Rating Scale (MADRS). It is a ten-item diagnostic questionnaire which psychiatrists use to measure the severity of depressive episodes. Higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60.
Group
Value
95% CI
Ketamine - Healthy Volunteers
2.45
± 3.79
Placebo - Healthy Volunteers
0.67
± 1.15
Ketamine - MDD Patients
23.73
± 10.32
Placebo - MDD Patients
30.68
± 5.50
Adverse events — posted to ClinicalTrials.gov
Time frame: 28 days.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Depressive disorders may be severe, chronic and often life-threatening illnesses. Impairment in physical and social functioning resulting from depression can be just as severe as other chronic medical illnesses. Recent preclinical and clinical studies suggest that the glutamatergic system is involved in the mechanism of action of antidepressants.
This study examines whether ketamine can cause a rapid-next day antidepressant effect in patients with Major Depressive Disorder.
This study was designed to address the questions:
Does the NMDA antagonist ketamine produce rapid antidepressant effects in patients with treatment-resistant major depression? What are the neurobiological correlates of antidepressant response (examining multi-modal MRI, MEG, polysomnography and serum markers) Patients, ages 18 to 65 years with treatment-resistant major (unipolar) depression will in a double-blind crossover study receive either intravenous ketamine or saline solution.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT05945147 — Ketamine and Midazolam Infusions for CRPS: Feasibility Study
· Phase 2
· withdrawn
NCT06963294 — Ketamine and Dexmedetomidine for Delirium in Joint Arthroplasty
· NA
· not yet recruiting
NCT07294092 — Ketamine and Propofol NeuroImaging
· EARLY_PHASE1
· recruiting
NCT07197684 — Ultrasound Guided Pecs Block and Ketamine Infusion for Preventing Chronic Pain in Patients Undergoing Breast Cancer Surg
· NA
· not yet recruiting
NCT06231563 — Ketamine for Veterans With Parkinson's Disease
· Phase 2
· recruiting
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Other National Institute of Mental Health (NIMH) trials
Trials by the same sponsor.
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· recruiting
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· Phase 2
· suspended
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Publications: Europe PMC API search by NCT ID, retrieved 9 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 National Institute of Mental Health (NIMH)
Last refreshed: 12 October 2018
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/NCT00088699.