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
Country United States of America
Visit trial
Status
Completed
Start date
03 January 2016
End date
01 January 2020
Chance of happening
100%
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.NCT Number NCT02487485
Sponsors & Collaborators
Yale UniversityThe Yale Psychedelic Science Group was established in 2016.
Measures Used
Montgomery-Asberg Depression Rating ScaleA 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.