NCT04939649CompletedPhase 3
Ketamine As an Adjunctive Therapy for Major Depression (2)
Ketamine As an Adjunctive Therapy for Major Depression - a Randomised Controlled Trial: [KARMA-Dep (2)]
Source: ClinicalTrials.gov · Last updated 13 Feb 2025
Brief summary (registry, in English)
Pragmatic, randomised, controlled, parallel-group, superiority trial of ketamine vs. midazolam as an adjunctive therapy for depression. The main purpose of the trial is to assess the mood-rating score difference between ketamine and midazolam from before the first infusion to 24 hours after the final infusion, supplemented by a 95% confidence interval. There will also be a 24-week follow-up after the final infusion session.
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 63 (actual)
- First submitted
- 20 Jun 2021
- Start date
- 13 Sept 2021
- Primary completion date
- 18 Apr 2024
- Lead sponsor
- University of Dublin, Trinity College
- Diseases
- Depression, Bipolar disorder
- NCT number
- NCT04939649
- EudraCT number
- 2019-003109-92
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 63
- From 13 Sept 2021 to the primary completion date, 18 Apr 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Currently taking any of the contraindicated medications that may alter the pharmacokinetics of ketamine.
- Lifetime history of schizophrenia or schizoaffective disorder; active anorexia nervosa or bulimia nervosa in the past 12 months; alcohol or other substance use disorder (with the exception of nicotine) in the previous six months; any DSM-5 disorder other than a major depressive episode (unipolar or bipolar) as the primary presenting problem.
- Electroconvulsive Therapy (ECT) administered within the last two months.
Other illness
- Medical condition rendering unfit for ketamine/midazolam.
- Dementia.
Other
- Current involuntary admission.
- Active suicidal intention.
- Pregnancy, breastfeeding or considering becoming pregnancy whilst on the trial for up to 12 weeks after last dose or inability to confirm use of adequate contraception during the trial.
- Breastfeeding women.
Who the study is looking for
- ≥18 years old.
- Montgomery-Åsberg Depression Rating Scale (MADRS) score ≥ 20 at screening and start of the first infusion.
- Voluntary admission for treatment of an acute depressive episode
- Meet DSM-5 criteria for a major depressive disorder or bipolar affective disorder (current episode depression). Diagnosis of a major depressive disorder or bipolar affective disorder (DSM-5) will be confirmed by the structured diagnostic Mini International Neuropsychiatric Interview (MINI; updated Version 7 for DSM-5).
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| St Patrick's Univeristy Hospital Coordinator of this site? Confirm its status | Dublin | Ireland | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.