Ketamine Versus Placebo for Treatment Resistant Major Depressive Disorder
Randomised, triple-blind, placebo-controlled parallel trial (n=37) of IV ketamine infusions (6 infusions over 3 weeks, twice weekly) versus saline in treatment-resistant major depressive disorder.
Detailed Description
Randomised, triple-blind, parallel-group trial testing repeated intravenous ketamine as augmentation for treatment-resistant major depressive disorder; participants received six infusions over three weeks (twice weekly).
Prior single-dose ketamine studies showed acute reductions in depression scores and suicidal ideation; this study evaluated feasibility and efficacy of repeated administration versus saline on depressive symptoms.
Study Protocol
Preparation
Dosing
Integration
Study Arms & Interventions
Ketamine
experimentalIntravenous ketamine infusions given twice weekly for 3 weeks (6 total) as augmentation of ongoing antidepressant regimen.
Interventions
- Ketaminevia IV• twice weekly• 6 doses total
IV infusions twice weekly for 3 weeks (6 total) as augmentation of ongoing antidepressant regimen.
Placebo
inactiveIntravenous normal saline infusions matching ketamine schedule (6 infusions over 3 weeks).
Interventions
- Placebovia IV• twice weekly• 6 doses total
Normal saline infusions matching ketamine schedule (6 total).
Participants
Inclusion Criteria
- Inclusion Criteria:
- Outpatient with severe treatment-resistant depression
- 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 illness, including bipolar disorder
- No history of psychosis
- No history of drug abuse
- No major medical illness or unstable medical problem
Study Details
- StatusCompleted
- PhasePhase NA
- Typeinterventional
- DesignRandomizedtriple Blind
- Target Enrollment37 participants
- TimelineStart: 2013-01-01End: 2015-11-01
- Compounds
- Topic