NCT03290963

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

Targeting mTOR/GSK3 With Lithium Augmentation to Enhance and Sustain Rapid Antidepressant Actions of Ketamine in Adults With Treatment-Resistant Depression: A Precision Medicine Approach for Psychiatry

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: William V. Bobo, M.D. · Academic / Other
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a randomized clinical trial in adults with Treatment-Resistant Depression. All participants will receive three intravenous (IV) Ketamine (KET) infusions over 7 days. Before receiving the first KET infusion, subjects will be randomized to 2 weeks of pre-KET treatment with either Lithium or matching placebo. Pre-treatment medications will then be continued in a double-blind manner during the acute phase administration of ketamine. Questionnaires will be administered at baseline, prior to each KET infusion, and at 40, 100, and 120 minutes after each infusion, and again at weekly intervals following the third (final) KET infusion for 4 weeks, using standardized rating scales. Those who achieve positive response (\>50% decrease in questionnaire total score from baseline) will be given 4 additional once-weekly KET infusions (same dose and infusion rate).

Conditions

• Treatment Resistant Depression

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2017-11-30
• Primary completion: 2018-12-01
• Completion: 2018-12-01
• First posted: 2017-09-25
• Last updated: 2018-08-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study