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D-cycloserine for Relapse Prevention Following Intravenous Ketamine in Treatment-resistant Depression

Unknown statusRegisteredCTG

Two-stage trial (n=60): open-label six IV ketamine infusions (0.5 mg/kg over 40 min) followed by double-blind randomised maintenance D-cycloserine versus placebo (titrated to 1000 mg/day) in ketamine responders to prevent relapse in TRD.

Details

This study first administers six IV sub-anesthetic ketamine infusions (0.5 mg/kg over 40 minutes) over three weeks; responders (≥25% MADRS reduction) enter a randomised, triple-blind, placebo-controlled maintenance phase.

Responders are randomised to oral D-cycloserine or matched placebo, titrated 250→500→750→1000 mg/day and continued for eight weeks to evaluate relapse prevention; outcomes include MADRS, CGI, safety and vitals.

Topics:Treatment-Resistant Depression (TRD)

Registry

Registry linkNCT02772211