Phase 1
N=25
Ketamine as an Adjunctive Therapy for Major Depression
Major Depressive Episode · Unipolar Depression · Bipolar Depression
Bottom Line
View on ClinicalTrials.gov: NCT03256162 ↗Enrolled (actual)
25
Serious AEs
0.0%
Results posted
Jan 2020
Primary outcome: Primary: The Hamilton Rating Scale for Depression-24 Item Version (HRSD-24) — 11.2; 16.6 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Ketamine (Drug); Midazolam (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- St Patrick's Hospital, Ireland
- Primary completion
- Sep 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Hamilton Rating Scale for Depression-24 Item Version (HRSD-24) |
11.2; 16.6 | — |
| SECONDARY The Quick Inventory of Depressive Symptoms, Self-report Version (QIDS-SR16) |
9.1; 11.4 | — |
| SECONDARY The Clinician-Administered Dissociative States Scale (CADSS) |
5.3; 2.5 | — |
| SECONDARY The Brief Psychiatric Rating Scale (BPRS) |
4.1; 4.0 | — |
| SECONDARY Young Mania Rating Scale (YMRS; Mood Item) |
0.1; 0.1 | — |
| SECONDARY The Patient-Rated Inventory of Side Effects (PRISE) |
1; 1; 0; 0; 0; 0 | — |
| SECONDARY The Montreal Cognitive Assessment (MoCA) |
26.4; 28.5 | — |
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.
Eligibility Criteria
Inclusion Criteria
- ≥18 years old
- Hamilton Rating Scale for Depression-24 item version (HRSD-24) score of ≥21
- Voluntary admission for treatment of an acute depressive episode
- Meet Diagnostic and Statistical Manual of Mental Disorders , Fifth Edition (DSM-V) criteria for a major depressive disorder (MDD) and bipolar affective disorder (current episode depression)
Exclusion Criteria
- Current involuntary admission
- Medical condition rendering unfit for ketamine/midazolam
- Active suicidal intention
- Dementia
- History of Axis 1 diagnosis other than major depression
- Electroconvulsive Therapy (ECT) administered within the last two months
- Alcohol/substance dependence in previous six-months
- Pregnancy or inability to confirm use of adequate contraception during the trial
- Breastfeeding women
Data sourced from ClinicalTrials.gov (NCT03256162). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.