At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 25 enrolled
Drug / intervention
Ketamine +1 moredrug
Likely dose
Sub-anesthetic dose of ketamine administered in four infusions, each one week apartAI-extracted
Key inclusion· 4
- ✓Age 18 years or older
- ✓HRSD-24 score of 21 or higher
- ✓Voluntary admission for acute depressive episode treatment
- ✓Meet DSM-V criteria for major depressive disorder or bipolar affective disorder (current depressive episode)
Key exclusion· 7
- ✕Current involuntary admission
- ✕Medical condition rendering unfit for ketamine or midazolam
- ✕Active suicidal intention
- ✕Dementia
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Ketamine as an Adjunctive Therapy for Major Depression - a Randomised Controlled Pilot Trial: The KARMA-Dep Trial
In Brief
A Phase 1 clinical trial evaluating Ketamine and Midazolam for Major Depressive Episode and 2 related conditions. Completed, enrolled 25 participants across 1 site.
Detailed Summary
Randomised, controlled, parallel-group, pilot clinical trial of ketamine vs. midazolam as an adjunctive therapy for depression. The main purpose of the pilot study is to assess trial processes to help inform a future definitive trial.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesIreland
Collaborators--
Timeline
Phase 1CompletedFinished
201820192020202120222023202420252026
First PostedAug 2017
Enrollment StartSep 2017
Primary CompletionSep 2018
TodayJul 2026
First PostedAug 21, 2017
Enrollment StartSep 7, 2017
Primary CompletionSep 21, 2018
TodayJul 2, 2026
Enrollment to primary: 1.0 yearsPosted 8.9 years ago
Interventions
Ketaminedrug
A sub-anaesthetic dose of ketamine will be administered in four infusions, each one week apart.
Midazolamdrug
A sub-anaesthetic dose of midazolam will be administered in four infusions, each one week apart.