CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 23 enrolled
Drug / intervention
Ketamine +2 moredrug
Likely dose
Ketamine 0.5 mg/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/NCT02487485
NCT02487485Phase 2Completed

Examining the Impact of Sirolimus on Ketamine's Antidepressant Effects

Yale University·interventional·Posted Jul 1, 2015·Updated Jul 16, 2020

In Brief

A Phase 2 clinical trial evaluating Ketamine, sirolimus, and 1 other intervention for Depression. Completed, enrolled 23 participants across 2 sites.

Detailed Summary

The aim of the study is to provide insight into the impact of the immunosuppressant drug sirolimus, on the antidepressant effects of the prototypal rapid-acting antidepressant medication, ketamine.

Study Details

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

Timeline

Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedJul 1, 2015
Enrollment StartMar 1, 2016
Primary CompletionJan 1, 2020
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 11.0 years ago

Interventions

Ketaminedrug

. Subjects will receive an infusion of ketamine (0.5 mg/kg infusion over approximately 40 minutes). All subjects will receive two ketamine infusions-once with a placebo and once with a single dose of sirolimus (6 mg, oral administration).

sirolimusdrug

Subjects will receive a single 6 mg oral dose via oral solution of sirolimus or a dose of placebo approximately two hours prior to the infusions. As above, the order of placebo and sirolimus is randomized. The sirolimus dose as well as the placebo solution will be given in 6 ounces of orange juice.

Placebodrug

Placebo oral dose