i-CBT and IV Ketamine for Suicidality in Treatment-Resistant Depression: A Randomized, Midazolam-Controlled Clinical Trial

PHASE2RecruitingINTERVENTIONAL
Enrollment

110

Participants

Timeline

Start Date

January 2, 2024

Primary Completion Date

March 31, 2026

Study Completion Date

June 30, 2026

Conditions
Major Depressive DisorderSuicideTreatment Resistant Depression
Interventions
DRUG

Ketamine hydrochloride

55 patients will receive ketamine hydrochloride, over six infusions, flexibly dosed between 0.5 mg/kg to 0.85 mg/kg.

BEHAVIORAL

i-CBT (Internet-based Cognitive Behavioural Therapy)

Each week for 13 weeks, participants will watch an online module that last approximately 45-50 mins each, with homework at the end of each module. Homework is submitted and reviewed by a therapist, who will provide personalized feedback before progression to the next module.

DRUG

Midazolam Hydrochloride

55 patients will receive midazolam hydrochloride, over six infusions, flexibly dosed between 0.02 mg/kg to 0.035 mg/kg.

Trial Locations (2)

Unknown

RECRUITING

Toronto General Hospital, Toronto

RECRUITING

Ontario Shores Centre for Mental Health Sciences, Whitby

All Listed Sponsors
collaborator

Ontario Shores Centre for Mental Health Sciences

OTHER

lead

University Health Network, Toronto

OTHER