Ketamine Infusion for Treatment-resistant Major Depressive Disorder
Open-label pilot study (n=14) assessing IV ketamine (0.5 mg/kg over 45 min; twice weekly for 3 weeks) as augmentation for chronic suicidal ideation in severe treatment-resistant depression.
Detailed Description
This open-label pilot evaluates the feasibility, safety, tolerability, efficacy and duration of IV ketamine as augmentation to existing antidepressant regimens in patients with severe treatment-resistant depression and chronic suicidal ideation.
Participants undergo two weeks of observation, receive ketamine 0.5 mg/kg IV over 45 minutes twice weekly for three weeks (six infusions) with possible escalation to 0.75 mg/kg for non-responders after three infusions, and are followed biweekly for three months.
Outcomes include safety and tolerability measures, feasibility, and depression/suicidality assessments to determine duration of antidepressant effect when used as augmentation.
Study Protocol
Preparation
Dosing
Integration
Study Arms & Interventions
Ketamine IV
experimentalOpen-label augmentation with IV ketamine 0.5 mg/kg, twice weekly for 3 weeks (6 infusions); non-responders may escalate to 0.75 mg/kg after 3 infusions.
Interventions
- Ketamine0.5 mg/kgvia IV• twice weekly• 6 doses total
Infusion over 45 minutes; non-responders may escalate to 0.75 mg/kg after 3 infusions.
Participants
Inclusion 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
- 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
Study Details
- StatusCompleted
- PhasePhase NA
- Typeinterventional
- DesignNon-randomized
- Target Enrollment14 participants
- TimelineStart: 2012-01-04End: 2014-01-12
- Compound
- Topic