Conditions: Treatment Resistant Depression
Keywords: Depression Treatment Resistant Depression Ketamine Antidepressant MDD Major Depression
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 99
Healthy volunteers: no

Brief summary:
This study is looking at the efficacy, durability, safety, and tolerability of multiple single doses of Ketamine vs. active placebo for treating patients with treatment resistant depression who are taking an antidepressant that is not working for them.

Detailed description:
The primary objective is to investigate whether all doses (0.1 mg/kg, 0.2 mg/kg, 0.5 mg/kg, and 1.0 mg/kg) of ketamine are superior to active placebo (midazolam 0.045 mg/kg) therapy in the acute treatment of patients with treatment resistant depression within 72 hours (Day 3), when added to ongoing and stable antidepressant therapy.

Arms:
arm 1: Patients in this arm will receive 0.1 mg/kg of Ketamine - one single infusion arm 2: Patients in this arm will receive 0.2 mg/kg of Ketamine - one single infusion arm 3: Patients in this arm will receive 0.5 mg/kg of Ketamine - one single infusion arm 4: Patients in this arm will receive 1.0 mg/kg of Ketamine - one single infusion arm 5: Patients in this arm will receive 0.045 mg/kg of midazolam - one single infusion

Interventions: intervention 1: Ketamine intervention 2: Ketamine intervention 3: Ketamine intervention 4: Ketamine intervention 5: Placebo Midazolam
Intervention descriptions: intervention 1: Dose of Ketamine will be 0.1 mg/kg - one single infusion intervention 2: Dose of Ketamine will be 0.2 mg/kg - one single infusion intervention 3: Dose of Ketamine will be 0.5 mg/kg - one single infusion intervention 4: Dose of Ketamine will be 1.0 mg/kg - one single infusion intervention 5: Dose of Midazolam (active placebo) will be 0.045 mg/kg - one single infusion

Protocol document: