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

This Phase II randomised, controlled clinical trial (n=70) will compare ketamine-assisted psychotherapy (KAP) to ketamine administered without psychotherapy (KET) for the treatment of major depressive disorder (MDD).

The study, conducted by the Icahn School of Medicine at Mount Sinai in New York, aims to investigate the efficacy of combining psychotherapy with ketamine treatment compared to ketamine alone. Participants, who must be adults aged 18-90 with MDD, will be randomly assigned to either the KAP or KET group in a 1:1 ratio. Both groups will receive treatment over a four-week period.

The researchers will measure depression severity, wellness, neurocognitive functioning, and other parameters at baseline, immediately after the treatment period, and during an 8-week follow-up.

This Phase II trial seeks to determine whether the addition of psychotherapy to ketamine treatment provides enhanced benefits for patients with depression. The study is expected to run from August 2024 to August 2027, potentially offering new insights into optimising ketamine-based interventions for MDD.

Trial Details

The proposed study is a single-site, randomized, controlled clinical trial (RCT) comparing ketamine-assisted psychotherapy (KAP) to a standard evidence-based regimen of ketamine administered in a medical model without psychotherapy (KET). Eligible study participants will be adults with major depressive disorder (MDD). Adults with MDD will be randomized to KAP or KET in a 1:1 allocation. Each treatment group will receive KAP or KET over a period of four weeks. Measurement of depression severity, wellness, neurocognitive functioning and other parameters will occur at baseline prior to treatment, immediately following the end of the acute treatment period, and over an 8-week (two month) treatment follow-up period.

NCT Number NCT06559826

Data attribution

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