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Ketamine-Assisted Psychotherapy (KAP) Compared to Ketamine Alone for the Treatment of Depression (KAP)

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Single-site, randomised, controlled RCT (n=70) comparing ketamine-assisted psychotherapy (KAP) to standard medical ketamine (KET) for MDD over four weeks; ketamine doses personalised 0.3–1.0 mg/kg.

Details

Randomised, parallel-group, single-blind (outcomes assessor) trial enrolling adults with major depressive disorder to receive either weekly KAP sessions (IM ketamine, 0.3–1.0 mg/kg, 4–5 sessions) or a standard medical IV ketamine regimen (twice-weekly for three weeks then a single infusion in week four, up to seven infusions).

Assessments include depression severity, wellness, neurocognitive functioning and safety at baseline, end of acute treatment, and over an eight-week follow-up. Preparatory and integration psychotherapy sessions are provided in the KAP arm; matched psychoeducation provided in the KET arm.

Topics:Major Depressive Disorder (MDD)

Registry

Registry linkNCT06559826