Pharmacologic treatment augmentation in chronic depression randomised, controlled, double-blinded, Phase II study
Randomised, double-blinded, placebo-controlled Phase II trial (n=60) testing intravenous ketamine (Ketamin Inresa) with CBASP versus placebo+CBASP and ketamine+treatment-as-usual for chronic, treatment-resistant depression in Germany.
Details
Multi-arm, randomised, double-blinded Phase II study evaluating whether adding intravenous ketamine to CBASP leads to greater reduction in depressive symptoms versus placebo plus CBASP and versus ketamine plus treatment as usual.
Primary outcome is change in MADRS from baseline to six weeks after end of combination treatment; secondary outcomes include longer-term MADRS changes and self-reported BDI scores up to three months follow-up.
Active product: Ketamin Inresa (intravenous infusion). Placebo comparator: 0.9% NaCl infusion. CBASP is delivered as structured psychotherapy for relevant arms.