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

PHASE2RecruitingINTERVENTIONAL
Enrollment

70

Participants

Timeline

Start Date

January 10, 2025

Primary Completion Date

August 31, 2027

Study Completion Date

August 31, 2027

Conditions
Major Depressive Disorder
Interventions
DRUG

Ketamine

Following screening and baseline assessments, individuals randomized to KAP will undergo a preparatory session prior to the first day of dosing. Participants will complete a sequence of four to five intramuscular (IM) ketamine assisted therapy sessions.

BEHAVIORAL

Psychotherapy

Each week following KAP, there will be a separate 60-minute integration session 1-6 days afterwards. Integration sessions will focus on processing experiences and material that emerged in KAP sessions (such as assimilating challenging experiences, making meaning of experiences and imagery, working through memories and emotions, and exploring emerging relational patterns) as well as strengthening insights. Within one week of the completion of all KAP sessions, there will be one additional integration session focused on consolidating the insights and improvements gained from KAP treatment.

Trial Locations (1)

10029

RECRUITING

Icahn School of Medicine at Mount Sinai, New York

All Listed Sponsors
lead

Icahn School of Medicine at Mount Sinai

OTHER