Patients will be assessed with HAMD-28 weekly for the first 8 weeks, then every two weeks for another 8 weeks. Participants were considered as responders if there was a ⩾50% improvement on the HAM-D28.
Ketamine Infusion for Treatment-resistant Major Depressive Disorder
Brief 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).
Intervention / Treatment
-
Ketamine (DRUG)Ketamine IV 0.5mg/kg infusion twice a week for 3 weeks as augmentation of ongoing antidepressant regimen
Condition or Disease
- Major Depressive Disorder
Phase
Study Design
| Study type: | INTERVENTIONAL |
|---|---|
| Status: | Completed |
| Study results: | No Results Available |
| Age: | 18 Years to 65 Years |
| Enrollment: | 14 (ACTUAL) |
| Funded by: | Other |
| Allocation: | N/A |
| Primary Purpose: | Treatment |
Masking |
|
Clinical Trial Dates
| Start date: | Apr 01, 2012 | |
|---|---|---|
| Primary Completion: | Sep 01, 2014 | ACTUAL |
| Completion Date: | Dec 01, 2014 | ACTUAL |
| Study First Posted: | Apr 23, 2012 | ESTIMATED |
| Results First Posted: | Apr 20, 2017 | ACTUAL |
| Last Updated: | Apr 18, 2017 |
Sponsors / Collaborators
Lead Sponsor:
Massachusetts General Hospital
Responsible Party:
N/A
Location
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.
Total duration of the study is 5 months.
Participant Groups
-
Patients will receive open label augmentation with IV Ketamine at 0.5mg/kg, twice a week for 3 weeks
Eligibility Criteria
| Sex: | All |
|---|---|
| Minimum Age: | 18 |
| Maximum Age: | 65 |
| Age Groups: | Adult / Older Adult |
| Healthy Volunteers: | Yes |
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
* 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
Primary Outcomes
More Details
| NCT Number: | NCT01582945 |
|---|---|
| Other IDs: | 2010-P-002800 |
| Study URL: | https://clinicaltrials.gov/study/NCT01582945 |
Last updated: Sep 29, 2023