Last updated on August 2017

Ketamine for Treatment Resistant Late-Life Depression


Brief description of study

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

Detailed Study Description

Primary Aim: To identify and evaluate the durability of benefit of the best performing of 3 sub-anesthetic doses of a single ketamine (0.1 mg/kg, 0.25 mg/kg, and 0.50 mg/kg) and midazolam (MID) (0.03 mg/kg) infusion in up to 72 Veterans with Late-Life Treatment Resistant Depression (LL-TRD). Hypothesis 1: the durability of benefit of a single KET 0.5 mg/kg infusion is superior to (0.1 mg/kg, 0.25 mg/kg, and MID 0.03 mg/kg) time to relapse as measured by repeated measurements using the Montgomery-Asberg Depression Rating Scale (MADRS) during a four-week, post-infusion follow-up. Secondary Aim: To evaluate and compare the antidepressant efficacy of the best performing of 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 vets with LL-TRD, using a triple blind (patient, rater, anesthesiologist) Bayesian adaptive randomization design. 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 72-hour post-infusion. Tertiary Aim: To evaluate the immediate and longer-term safety and tolerability of the most effective KET infusion (0.5 mg/kg) relative to MID (0.03 mg/kg) in vets with LL-TRD. Hypothesis 3: KET infusion at the most effective dose (0.5 mg/kg) 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 (0.50 mg/kg) relative to MID (0.03 mg/kg) on neurocognitive performance. 2. To measure the effects the most effective dose of KET (0.50 mg/kg) relative to MID (0.03 mg/kg) on peripheral biomarkers of cellular plasticity and inflammation. 3. To measure the effects the most effective dose of KET (0.50 mg/kg) relative to MID (0.03 mg/kg) on resting-state quantitative electroencephalography.

Clinical Study Identifier: NCT02556606

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Sanjay Mathew, MD

Michael E. DeBakey VA Medical Center, Houston, TX
Houston, TX United States
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