Pharmacologic Treatment Augmentation in Chronic Depression (Ket+CBASP)
Randomised, quadruple-blind, Phase II trial (n=60) comparing ketamine (0.5 mg/kg IV, 6 infusions over 3 weeks) plus CBASP or TAU versus placebo plus CBASP in patients with stage-2 treatment-resistant chronic depression.
Details
This parallel, randomised study enrols adults 18–64 with chronic, treatment‑resistant depression (stage 2) and randomises them to Ketamine+CBASP, Ketamine+TAU, or Placebo+CBASP. Psychotherapy (CBASP or TAU) runs alongside drug/placebo administration.
Drug treatment comprises 0.5 mg/kg ketamine infusions administered intravenously twice weekly for three weeks (six 40‑minute infusions). Placebo is isotonic saline administered with the same schedule. Outcomes include clinical scales, blood biomarkers, and fMRI at baseline, during, and at follow‑up.
Screening includes clinical interview, physical exam, ECG, urine drug screen and blood tests including pregnancy testing. Follow-up therapy is arranged after study completion; final data collection occurs three months after treatment end.