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

This single-site, randomised, controlled clinical trial (n=70) will compare ketamine-assisted psychotherapy (KAP) to standard medical ketamine administration (KET) for the treatment of major depressive disorder (MDD), using doses ranging from 21 mg/70 kg to 70 mg/70 kg.

Participants will be randomly assigned to receive either KAP or KET over a four-week period. The KAP group will undergo preparatory sessions followed by four to five intramuscular ketamine-assisted therapy sessions, with integration therapy sessions focused on processing and consolidating insights. The KET group will receive intravenous ketamine twice weekly for three weeks, followed by a single down-titration dose in the fourth week, with no formal psychotherapy.

Depression severity and neurocognitive functioning will be assessed at baseline, post-treatment, and during an eight-week follow-up period. The study is sponsored by the Icahn School of Medicine at Mount Sinai and is expected to run from January 2025 to August 2027.

Topic Depression
Compound Ketamine
Country United States of America
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Trial Details



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Sponsors & Collaborators

Icahn School of Medicine at Mount Sinai
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