Examining the Impact of Sirolimus on Ketamine's Antidepressant Effects

Completed · Phase 2 · Has a placebo group

Conditions studied: Depression

In brief

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.

Key facts

Study ID

NCT02487485

Run by

Yale University

People needed

23

Starts

2016-03-01

Expected to finish

2020-01-01

Last updated by the study team

2020-07-16

Who can join

Age: 21 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Veterans and non-Veterans between the ages of 21-65.
• Diagnosis of Major Depressive Episode (unipolar or bipolar) as determined by the Mini International Neuropsychiatric Interview (MINI).
• Antidepressant-resistant depressive symptoms, defined by a history of failure of one or more adequate antidepressant trials.
• Stable doses of antidepressants (if prescribed) for a period of four weeks or longer at the time of randomization, except for MAOIs which are prohibited.
• Stable course of psychotherapy (if engaged in) for a period of four weeks or longer at the time of randomization.
• Females will be included if they are not pregnant or breastfeeding and agree to utilize a medically accepted birth control method (to include oral, injectable, or implant birth control, condom, diaphragm with spermicide, intrauterine device, tubal ligation, abstinence, or partner with vasectomy) or if post-menopausal for at least 1 year, or surgically sterile. For those women who are taking an oral contraceptive, we will also ask that they use (or ask their partners to use) a barrier method contraceptive.
• Able to provide written informed consent according to VA HSS guidelines.
• Ability to read and write in English.
• A score greater than or equal to 18 on the Montgomery Åsberg Depression Rating Scale (MADRS).

You may not qualify if…

• Subjects with a diagnostic history of schizophrenia or schizoaffective disorder, or currently exhibiting manic or mixed episodes or psychotic features as confirmed by the Mini International Neuropsychiatric Inventory.
• Current, ongoing serious suicidal risk as assessed by evaluating investigator or by scoring 5 or more on the item-10 of the MADRS.
• Patients with unstable or inadequately controlled medical conditions.
• Patient requiring prohibited medication.
• Patient with history of organ transplant.
• Meet criteria for a diagnosis of substance dependence (amphetamines, cocaine, hallucinogens, inhalants, opioids, sedatives/hypnotics/anxiolytics) within the three months prior to screening date.
• Positive urine drug screen for cannabis, cocaine, PCP, or barbiturates.
• Positive pregnancy test at screening at any screen given during the study.
• Known sensitivity to sirolimus or ketamine.
• History of sensitivity to heparin or heparin-induced thrombocytopenia.
• Resting blood pressure lower than 85/55 or higher than 150/95, or resting heart rate lower than 45/min or higher than 100/min.

Where it is running

• Yale New Haven Hospital — New Haven, Connecticut, United States
• West Haven Veterans Affairs — West Haven, Connecticut, United States

Full record on ClinicalTrials.gov

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