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NCT05026203
Effectiveness of Ketamine Treatment for Three Consecutive Days in Depression
Phase 4 trial testing Ketamine Hydrochloride in Depression in 24 participants. Completed in 30 November 2023.
31 July 2022
Quick facts
| Lead sponsor | Mahidol University |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 24 |
| Start date | 1 September 2021 |
| Primary completion | 31 July 2022 |
| Estimated completion | 30 November 2023 |
| Sites | 1 location across Thailand |
Drugs / interventions tested
- Ketamine Hydrochloride — full drug profile →
- Midazolam (midazolam) — full drug profile →
Conditions studied
- Depression — all drugs for Depression →
Sponsor
Mahidol University
Who can join
20 and older, any sex, with Depression. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Inclusion criteria: 1. patient over 20 years old with depression diagnosed by a psychiatrist and MADRS \>= 25 scores; 2. failed to improve by at least optimal dosage of two antidepressants for four weeks and one psychotherapy. Patients and outcome assessors will be blinded from intervention the patients have. Participants will be randomized into two groups that are intervention (ketamine 0.5 mg/kg IV drip in 40 minutes) and control (midazolam 0.045 mg/kg IV drip in 40 minutes) groups. Participants will administer ketamine/midazolam once daily for three consecutive days. They will be evaluate MADRS changing, vital signs, dissociative symptoms, CGI, and quality of life (EQ-5D-5L) during the treatment, at 1 week and 4 weeks after treatment completion.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
A randomized controlled pilot study of daily intravenous ketamine over three days for treatment-resistant depression.
Pattanaseri K, Lortrakul J, Jaisin K, Srifuengfung M, et al · · 2024 · cited 6× · PMID 39026266 · DOI 10.1186/s12888-024-05951-5 -
Imidazoles as Serotonin Receptor Modulators for Treatment of Depression: Structural Insights and Structure-Activity Relationship Studies.
Goel KK, Thapliyal S, Kharb R, Joshi G, et al · · 2023 · cited 5× · PMID 37765177 · DOI 10.3390/pharmaceutics15092208 -
Intravenous ketamine is ineffective compared to midazolam for treatment-resistant depression: a double-blind, randomized controlled study
Pattanaseri K, Lortrakul J, Jaisin K, Srifuengf M, et al · · 2024 · DOI 10.21203/rs.3.rs-4179664/v1
Verify or expand the search:
- PubMed search for NCT05026203
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Ketamine Hydrochloride
Trials testing the same drug.
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- NCT06090422 — Ketamine for Combined Depression and Alcohol Use Disorder · Phase 1, PHASE2 · not yet recruiting
- NCT06496750 — Ketamine for Methamphetamine Use Disorder · Phase 2 · recruiting
- NCT05973851 — The Effect of a Six Week Intensified Pharmacological Treatment for Major Depressive Disorder Compared to Treatment as Us · Phase 3 · recruiting
- NCT06366334 — Study of IV Ketamine for Emergency Department Treatment of Adolescent Suicidal Ideation · NA · recruiting
Other recruiting trials for Depression
Currently open trials in the same condition.
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Other Mahidol University trials
Trials by the same sponsor.
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- NCT07407400 — Lemborexant for Sleep and Delirium Prevention in Elderly ICU Patients · Phase 4 · not yet recruiting
- NCT07378501 — Thai Version of the Pediatric Quality of Recovery Score (PedSQoR): Translation and Psychometric Validation Study · not yet recruiting
- NCT07438301 — Septic Shock Hemodynamic Respond to Volume Resuscitation Versus Vasopressor Administration · not yet recruiting
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05026203 (US National Library of Medicine, public domain)
- 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 Mahidol University
- Last refreshed: 15 March 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/NCT05026203.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing