Randomised, double-blind, placebo-controlled study (n=29 planned) assessing whether oral minocycline maintains antidepressant response after an open-label IV ketamine induction (0.5 mg/kg, six infusions) in patients with MDD and Bipolar II.
This parallel, randomised, double-blind trial enrolled patients with moderate to severe major depressive disorder or Bipolar Disorder Type II who completed a 12-day open-label induction of six IV ketamine infusions (0.5 mg/kg) combined with minocycline.
Responders to the induction phase were randomised to oral minocycline 100 mg twice daily or matched placebo for up to 6 weeks to assess maintenance of antidepressant response; non-responders could receive open-label minocycline.
Primary efficacy assessed by MADRS; safety and tolerability monitored throughout with weekly visits until Day 54 or relapse.
Responders randomised to oral minocycline 100 mg twice daily for up to 6 weeks (blinded phase).
Blinded phase: 100 mg twice daily from evening of Day 12 for up to 6 weeks (or until relapse).
Open-label induction schedule: Day 1 200 mg, Days 2–11 100 mg twice daily, Day 12 100 mg morning.
Responders randomised to matched placebo twice daily for up to 6 weeks (blinded phase).
Placebo twice daily from evening of Day 12 for up to 6 weeks (or until relapse).
All participants receive open-label IV ketamine 0.5 mg/kg infusions plus open-label minocycline during a 12-day induction (six infusions).
IV infusion over 40 minutes on Days 1,3,5,8,10,12.
Open-label minocycline during induction: Day 1 200 mg, Days 2–11 100 mg twice daily, Day 12 100 mg morning.