N/A
N=14
Ketamine Infusion for Treatment-resistant Major Depressive Disorder
Major Depressive Disorder
Bottom Line
View on ClinicalTrials.gov: NCT01582945 ↗Enrolled (actual)
14
Serious AEs
0.0%
Results posted
Apr 2017
Primary outcome: Primary: Response to Ketamine as Measured by Hamilton Depression Rating Scale -28 Items (HAMD28) — 5 participants who met response criteria
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Ketamine (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Massachusetts General Hospital
- Primary completion
- Sep 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Response to Ketamine as Measured by Hamilton Depression Rating Scale -28 Items (HAMD28) |
5 | — |
Summary
Ketamine infusion has been shown to have rapid antidepressant properties, however the possible use of ketamine in treatment-resistant depression as augmentation has not been investigated. The overall aim of this study is to assess the feasibility, safety and tolerability, efficacy and duration of the effect of intravenous N-methyl-D-aspartate antagonist ketamine as augmentation of antidepressants for chronic suicidal ideation in subjects with severe treatment-resistant depression (TRD).
This is an open-label study (pilot).
Eligibility Criteria
Inclusion Criteria
- Outpatients with severe treatment-resistant MDD
- Currently depressed
- Currently under regular psychiatric care
- On an aggressive antidepressant regimen, stable for 4 weeks
Exclusion Criteria
- No history of other major psychiatric illnesses, including bipolar disorder
- No history of psychosis
- No history of drug abuse
- No major medical illness or unstable medical conditions
Data sourced from ClinicalTrials.gov (NCT01582945). 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.