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
Visit trial
Status Recruiting
Results Published No
Start date 01 January 2025
End date 01 August 2027
Phase Phase II
Design Blinded
Type Interventional
Generation First
Participants 70
Sex All
Age 18- 90
Therapy Yes

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.

Trial Number NCT06559826

Sponsors & Collaborators

Icahn School of Medicine at Mount Sinai
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Data attribution

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