NCT02556606

Ketamine for Treatment Resistant Late-Life Depression

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: VA Office of Research and Development · Federal
• Sex: All
• Age: 55 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to examine the effectiveness of a single infusion of ketamine (KET), to determine which dose is optimal 7 days after infusion using Bayesian Adaptive Randomization, and to learn about how ketamine works in the body and brain in persons with late-life treatment resistant depression.

Detailed description

Primary Aim: To identify the best performing condition across a single intravenous infusion of ketamine (KET) 0.1 mg/kg, KET 0.25 mg/kg, KET 0.50 mg/kg) and midazolam (MID) 0.03 mg/kg on Montgomery-Asberg Depression Rating Scale (MADRS) treatment response (at least a 50% improvement in depression from baseline) 7 days after the infusion in up to 72 Veterans with Late-Life Treatment Resistant Depression (LL-TRD) , using a triple blind (patient, rater, anesthesiologist) Bayesian adaptive randomization design. Hypothesis 1: Single KET 0.5 mg/kg infusion is superior to KET 0.1 mg/kg, KET 0.25 mg/kg, and MID 0.03 mg/kg measured by the proportion of participants demonstrating \> 50% reduction on MADRS scores 7 days post-treatment. Secondary Aim: To evaluate the durability of day 7 treatment response across 3 sub-anesthetic doses of a single KET (0.1 mg/kg, 0.25 mg/kg, and 0.50 mg/kg) and MID (0.03 mg/kg) infusion in veterans with LL-TRD during a 4 week follow-up. Hypothesis 2: a single KET 0.5 mg/kg infusion will be superior to a single infusion of KET 0.1 mg/kg, KET 0.25 mg/kg, and MID 0.03 mg/kg as measured by the proportion of participants demonstrating \> 50% reduction on MADRS scores at 28 days post-infusion. Tertiary Aim: To evaluate the immediate and longer-term safety and tolerability of the most effective KET infusion relative to MID in vets with LL-TRD. Hypothesis 3: KET infusion at the most effective dose will be safe and well tolerated compared to MID, as assessed by psychoactive and general side effect rating scales during and up to 4 weeks post study infusion. Exploratory Aims: 1. To measure the effects of the most effective dose of KET relative to MID on neurocognitive performance. 2. To measure the effects the most effective dose of KET relative to MID on peripheral biomarkers of cellular plasticity and inflammation. 3. To measure the effects the most effective dose of KET relative to MID on resting-state quantitative electroencephalography.

Conditions

• Treatment Resistant Depressive Disorder

Interventions

Type	Name	Description
DRUG	Ketamine	randomly assigned to a single 40 min infusion of either KET 0.1mg/Kg
DRUG	Ketamine	randomly assigned to a single 40 min infusion of either KET 0.25mg/Kg
DRUG	Ketamine	randomly assigned to a single 40 min infusion of either KET 0.50mg/Kg
DRUG	Midazolam	single 40 min infusion of MID 0.03mg/Kg

Timeline

• Start date: 2015-10-01
• Primary completion: 2020-03-31
• Completion: 2020-03-31
• First posted: 2015-09-22
• Last updated: 2022-01-11
• Results posted: 2021-08-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study