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Effect of Lithium Versus Placebo in Adults With Treatment-Resistant Depression Who Are Receiving Ketamine

NCT03290963 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2018-08-16

No results posted yet for this study

Summary

The purpose of this research study is to compare the antidepressant effect of lithium versus placebo in adults receiving ketamine. Lithium is available commercially for depression; ketamine is available commercially and can help the symptoms of depression; however, it has not been approved by the U.S. Food and Drug Administration (FDA) for this use. The FDA has allowed the use of this drug in this research study.

Conditions

Interventions

DRUG

Lithium

Lithium will be dosed in units (LI level \> or = 0.4 milliequivalents (mEq)/L)

DRUG

Placebo

Placebo tablets, dosed in units

DRUG

Ketamine

All subjects will receive 3 IV ketamine infusions of 0.5mg/kg, over 100 min. over 7 days.

Sponsors & Collaborators

  • William V. Bobo, M.D.

    lead OTHER

Principal Investigators

  • William V Bobo · Mayo Clinic

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-30
Primary Completion
2018-12-31
Completion
2018-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

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 NCT03290963 on ClinicalTrials.gov