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Ketamine for Treatment Resistant Late-Life Depression

NCT02556606 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2022-01-11

Study results available
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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.

Conditions

  • Treatment Resistant Depressive Disorder

Interventions

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

Sponsors & Collaborators

  • VA Office of Research and Development

    lead FED

Principal Investigators

  • Sanjay Mathew, MD · Michael E. DeBakey VA Medical Center, Houston, TX

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-10-01
Primary Completion
2020-03-31
Completion
2020-03-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02556606 on ClinicalTrials.gov