N/A
N=37
Ketamine Versus Placebo for Treatment Resistant Major Depressive Disorder
Major Depressive Disorder
Bottom Line
View on ClinicalTrials.gov: NCT01667926 ↗Enrolled (actual)
37
Serious AEs
7.7%
Results posted
Apr 2017
Primary outcome: Primary: Hamilton Depression Rating Scale - Suicidal Ideation (HDRS-SI) — 1.6; 1.6 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Ketamine (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Massachusetts General Hospital
- Primary completion
- Oct 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Hamilton Depression Rating Scale - Suicidal Ideation (HDRS-SI) |
1.6; 1.6 | — |
| SECONDARY HDRS-28 Total |
20.2; 20.0 | — |
Summary
Ketamine infusions resulted in an acute reduction in global depression scores and in severity of suicidal ideation. The investigators therefore plan to investigate the feasibility and efficacy of repeated intravenous administration of ketamine in severely depressed, treatment resistant patients. The results of the study could lead to development of new strategies for treating depression.
Eligibility Criteria
Inclusion Criteria
- Outpatient with sever treatment resistant depression
- Currently depressed
- Currently under regular psychiatric care
- On an aggressive antidepressant regimen, stable for 4 weeks.
Exclusion Criteria
- No history of other major psychiatric illness, including bipolar
- No history of psychosis
- No history of drug abuse
- No major medical illness or unstable medical problem
Data sourced from ClinicalTrials.gov (NCT01667926). 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.