CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 43 enrolled
Drug / intervention
Intravenous Ketamine +2 moredrug
Likely dose
Intravenous Ketamine 0.5mg/kgfrom 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/NCT05168735
NCT05168735Phase 2Completed
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Ketamine + Mindfulness for Depression

Rebecca Price·interventional·Posted Dec 23, 2021·Updated Aug 20, 2024

In Brief

A Phase 2 clinical trial evaluating Intravenous Ketamine, Brief Mindfulness Exercises, and 1 other intervention for Depression, Unipolar. Completed, enrolled 43 participants across 1 site.

Detailed Summary

In this project, the investigators will administer a single infusion of IV ketamine to depressed patients and randomize the patients to receive either a) usual/typical infusion conditions or b) mindfulness training and exercises in conjunction with the infusion. Investigators will test whether the conjunction of ketamine + mindfulness enhances the reductions in depression following a single ketamine infusion.

Study Details

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

Timeline

Phase 2CompletedFinished
20222023202420252026
First PostedDec 23, 2021
Enrollment StartFeb 1, 2022
Primary CompletionAug 1, 2023
Study CompletionSep 1, 2023
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 4.5 years ago

Interventions

Intravenous Ketaminedrug

Single infusion of intravenous racemic ketamine (0.5mg/kg over 40min)

Brief Mindfulness Exercisesbehavioral

30min guided training in mindfulness meditation immediately prior to infusion

Academic Exercisesbehavioral

30min of mental math and other academic cognitive puzzles completed silently/mentally