Ketamine Infusion for Treatment-resistant Major Depressive Disorder
| Status: | Completed |
|---|---|
| Conditions: | Depression, Major Depression Disorder (MDD) |
| Therapuetic Areas: | Psychiatry / Psychology, Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 9/23/2012 |
| Start Date: | April 2012 |
| End Date: | May 2014 |
| Contact: | Durham Kelley, Res. Coord. |
| Email: | kedurham@partners.org |
| Phone: | 1-877-552-5838 |
N-methyl-D-aspartate Antagonist (Ketamine) Infusion for Treatment-resistant Major Depressive Disorder With Suicidal Ideation
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).
Patients will undergo two weeks of prospective observation, they will then receive ketamine
IV 0.5mg/kg over 40 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 4 months.
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
We found this trial at
1
site
Click here to add this to my saved trials
