Ketamine Infusion for Treatment-resistant Major Depressive Disorder
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).
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||N-methyl-D-aspartate Antagonist (Ketamine) Infusion for Treatment-resistant Major Depressive Disorder With Suicidal Ideation|
- Hamilton Depression Rating Scale -28 items [ Time Frame: Weekly for total duration of 4 months ] [ Designated as safety issue: No ]Patients will be assessed with HAMD-28 weekly for the first 8 weeks, then every two weeks for another 8 weeks
- Systematic Assessment for Treatment Emergent Events (SAFTEE) [ Time Frame: Weekly for total duration of 4 months ] [ Designated as safety issue: Yes ]Patients will be monitored for emergence of side effects weekly for the first 8 weeks, then every two weeks for 8 weeks
|Study Start Date:||April 2012|
|Estimated Study Completion Date:||May 2015|
|Estimated Primary Completion Date:||September 2014 (Final data collection date for primary outcome measure)|
Experimental: Ketamine IV
Patients will receive open label augmentation with IV Ketamine at 0.5mg/kg, twice a week for 3 weeks
Ketamine IV 0.5mg/kg infusion twice a week for 3 weeks as augmentation of ongoing antidepressant regimen
Patients will undergo two weeks of prospective observation, they will then receive ketamine IV 0.5mg/kg over 45 minutes as augmentation of their ongoing antidepressant regimen; after three infusions this dose will be increased increase to 0.75 mg/kg in non-responders. The schedule of administration will be twice a week for 3 weeks. After this phase, the patient will be followed with assessments every two weeks for three months.
Total duration of the study is 5 months.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01582945
|United States, Massachusetts|
|Depression Clinical and Research Program - MGH|
|Boston, Massachusetts, United States, 02114|
|Principal Investigator:||Cristina Cusin, MD||MGH Department of Psychiatry|