CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 34 enrolled
Drug / intervention
Lithium +2 moredrug
Likely dose
Lithium 1200mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01880593
NCT01880593Phase 2Completed

Ketamine Plus Lithium as a Novel Pharmacotherapeutic Strategy in Treatment-Resistant Depression

Icahn School of Medicine at Mount Sinai·interventional·Posted Jun 19, 2013·Updated Jul 31, 2018

In Brief

A Phase 2 clinical trial evaluating Lithium, Ketamine, and 1 other intervention for Depression. Completed, enrolled 34 participants across 1 site.

Detailed Summary

The purpose of this study is to test the antidepressant effect of ketamine when given repeatedly over a period of 1 week, as well as the use of Lithium as a relapse-prevention strategy for patients with treatment-resistant depression (TRD) who respond to an initial series of ketamine infusions. Ketamine is a Food and Drug Administration approved anesthetic (a drug used to produce loss of consciousness before and during surgery). Ketamine is not approved for the treatment of major depressive disorder and is considered experimental in this study. An additional purpose of this study is to research the effects of ketamine on brain function. You may qualify to take part in this research study because you have been diagnosed with major depressive disorder (MDD) and have not responded to past treatments.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDepression
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJun 19, 2013
Enrollment StartJul 1, 2013
Primary CompletionNov 1, 2016
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 13.0 years ago

Interventions

Lithiumdrug

Subjects in this arm take 600-1200mg of Lithium pills at night for duration of the study.

Ketaminedrug

Placebodrug

Subjects in this arm take placebo pills at night for duration of the study.