Examining the Impact of Sirolimus on Ketamine's Antidepressant Effects



Status:Active, not recruiting
Conditions:Depression
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:21 - 65
Updated:1/13/2019
Start Date:March 2016
End Date:August 2019

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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.

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.

Inclusion Criteria:

1. Veterans and non-Veterans between the ages of 21-65.

2. Diagnosis of Major Depressive Episode (unipolar or bipolar) as determined by the Mini
International Neuropsychiatric Interview (MINI).

3. Antidepressant-resistant depressive symptoms, defined by a history of failure of one
or more adequate antidepressant trials.

4. 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.

5. Stable course of psychotherapy (if engaged in) for a period of four weeks or longer at
the time of randomization.

6. 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.

7. Able to provide written informed consent according to VA HSS guidelines.

8. Ability to read and write in English.

9. A score greater than or equal to 18 on the Montgomery Åsberg Depression Rating Scale
(MADRS).

Exclusion Criteria:

1. 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.

2. Current, ongoing serious suicidal risk as assessed by evaluating investigator or by
scoring 5 or more on the item-10 of the MADRS.

3. Patients with unstable or inadequately controlled medical conditions.

4. Patient requiring prohibited medication.

5. Patient with history of organ transplant.

6. Meet criteria for a diagnosis of substance dependence (amphetamines, cocaine,
hallucinogens, inhalants, opioids, sedatives/hypnotics/anxiolytics) within the three
months prior to screening date.

7. Positive urine drug screen for cannabis, cocaine, PCP, or barbiturates.

8. Positive pregnancy test at screening at any screen given during the study.

9. Known sensitivity to sirolimus or ketamine.

10. History of sensitivity to heparin or heparin-induced thrombocytopenia.

11. 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.
We found this trial at
2
sites
West Haven, Connecticut 06515
Phone: 203-932-5711
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20 York St, N20 York St,
New Haven, Connecticut 06520
(203) 688-4242
Phone: 347-987-0717
Yale-New Haven Hospital Relying on the skill and expertise of more than 4,500 university and...
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