Examining the Impact of Sirolimus on Ketamine’s Antidepressant Effects

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.

Topic Depression
Compound Placebo Ketamine
Country United States of America
Visit trial
Status Completed
Results Published
Start date 03 January 2016
End date 01 January 2020
Phase Phase II
Design Open
Type Interventional
Generation First
Participants 23
Sex All
Age 21- 65
Therapy No

Trial Details

This is a double blind, placebo-controlled, crossover, randomized controlled trial investigating the impact of sirolimus on ketamine's antidepressant effects in participants with antidepressant-resistant depressive symptoms. Prior to this, there was a phase 1 which included monitoring 3 subjects over the course of 7 days after a single dose of sirolimus and ketamine in order to inquire about side effects or interaction effects.

Trial Number NCT02487485

Sponsors & Collaborators

Yale University
The Yale Psychedelic Science Group was established in 2016.

Measures Used

Montgomery-Asberg Depression Rating Scale
A ten-item diagnostic questionnaire used to measure the severity of depressive symptoms in patients with mood disorders.

Quick Inventory of Depressive Symptomatology
The Quick Inventory of Depressive Symptomatology (Self-Report) (QIDS-SR16) is a self-report tool designed to screen for depression and measure changes in the severity of symptoms.

Hamilton Anxiety Scale
The Hamilton Anxiety Scale (HAM-A) was one of the first rating scales developed to measure the severity of anxiety symptoms and is still widely used today in both clinical and research settings.

Clinical-Administered Dissociative Symptoms Scale
The Clinical-Administered Dissociative Symptoms Scale (CADSS) is a scale used to measure dissociative states such as those induced by ketamine.

Data attribution

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