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This Indian pilot randomized controlled trial evaluated whether adjunctive intravenous ketamine could produce a rapid antidepressant response in severe major depressive disorder without established treatment resistance. Forty patients with severe depression, defined by a Hamilton Depression Rating Scale score of at least 19, were randomized to ketamine (0.5 mg/kg IV; n = 19) or placebo (n = 21), administered as four infusions on days 1, 3, 5, and 8. The primary outcome was a reduction of at least 50% in depression scores by day 12. The response rate was 58% with ketamine compared with 29% with placebo (P < 0.05), corresponding to a reported number needed to treat of 3.4. Significant improvement in depression scores was observed from day 2 onwards (P < 0.05). Complete resolution of suicidal ideation by day 5 was reported in the ketamine group, whereas ideation persisted in the placebo group (P < 0.001). Treatment completion was notably lower among patients with anxiety features, suggesting a potential factor affecting tolerability or treatment engagement. Benefits were reported to persist at the four-week follow-up. Conclusion: Adjunctive IV ketamine showed promising rapid antidepressant and anti-suicidal effects in this small Indian trial, but the sample size and short follow-up limit certainty. Larger, adequately powered studies are needed to establish durability, safety, and which patients are most likely to benefit.
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This Indian pilot randomized controlled trial evaluated whether adjunctive intravenous ketamine could produce a rapid antidepressant response in severe major depressive disorder without established treatment resistance. Forty patients with severe depression, defined by a Hamilton Depression Rating Scale score of at least 19, were randomized to ketamine (0.5 mg/kg IV; n = 19) or placebo (n = 21), administered as four infusions on days 1, 3, 5, and 8. The primary outcome was a reduction of at least 50% in depression scores by day 12. The response rate was 58% with ketamine compared with 29% with placebo (P < 0.05), corresponding to a reported number needed to treat of 3.4. Significant improvement in depression scores was observed from day 2 onwards (P < 0.05). Complete resolution of suicidal ideation by day 5 was reported in the ketamine group, whereas ideation persisted in the placebo group (P < 0.001). Treatment completion was notably lower among patients with anxiety features, suggesting a potential factor affecting tolerability or treatment engagement. Benefits were reported to persist at the four-week follow-up. Conclusion: Adjunctive IV ketamine showed promising rapid antidepressant and anti-suicidal effects in this small Indian trial, but the sample size and short follow-up limit certainty. Larger, adequately powered studies are needed to establish durability, safety, and which patients are most likely to benefit.
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