Ketamine for Severe Adolescent Depression: Intermediate-term Safety and Efficacy (SAD-KIDS)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03889756|
Recruitment Status : Active, not recruiting
First Posted : March 26, 2019
Last Update Posted : February 11, 2020
|Condition or disease||Intervention/treatment||Phase|
|Major Depressive Disorder||Drug: Ketamine infusion Drug: Midazolam infusion||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||24 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Phase 1 is a double-blind, midazolam-controlled parallel design trial; Phase 2 is an open extension.|
|Masking:||Double (Participant, Outcomes Assessor)|
|Masking Description:||Participants will not be told what medication they are receiving; physicians absent from the infusion paradigm will perform blinded clinical efficacy ratings.|
|Official Title:||Ketamine for Severe Adolescent Depression: Intermediate-term Safety and Efficacy|
|Actual Study Start Date :||July 17, 2019|
|Estimated Primary Completion Date :||September 2022|
|Estimated Study Completion Date :||November 2022|
Ketamine is an FDA-approved anesthetic agent that is commonly used to induce surgical anesthesia due to its low incidence of significant respiratory depression and hypotension. It as a N-methyl-D-aspartate (NMDA) receptor antagonist and glutamatergic modulator, and has been demonstrated in multiple controlled clinical trials to have rapidly acting antidepressant and anti-suicidal effects in adults.
Drug: Ketamine infusion
The dose of ketamine established in prior research (0.5 mg/kg over 40 minutes) will be used in this study to minimize risks. The maximum total single dose allowed in this study will be 40mg, corresponding to a weight of 80kg.
Placebo Comparator: Midazolam
Midazolam, the active control in this study, is a medication that is approved by the Food and Drug Administration as a sedative for both children and adults.It is a benzodiazepine with a short half-life that was chosen so as to blind the psychotomimetic effects of Ketamine.
Drug: Midazolam infusion
The weight-based midazolam dosing established in prior ketamine trials in adults (0.045mg/kg) will be used to minimize risks, as this is considered a very low dose compared to the sedation literature. The maximum total dose allowed in this study will be 3.6mg per infusion, corresponding to a weight of 80kg.
- Evaluate the efficacy of a multiple-dosing ketamine infusion paradigm (2 infusions per week for 3 weeks) compared to midazolam in adolescents with treatment resistant depression [ Time Frame: Day 18 ]Establish if repeated ketamine will be efficacious medically and psychiatrically, as measured by a significant reduction in CDRS score in those treated with ketamine at the end of the dosing paradigm
- Evaluate the tolerability of a multiple-dosing ketamine infusion paradigm (2 infusions per week for 3 weeks) compared to midazolam in adolescents with treatment resistant depression [ Time Frame: Day 18 ]Establish if repeated ketamine will be tolerated as measured by drop-out rates
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03889756
|United States, Connecticut|
|Yale Child Study Center|
|New Haven, Connecticut, United States, 06520|
|Principal Investigator:||Michael H. Bloch, MD||Yale University|
|Study Director:||Jennifer Dwyer, MD||Yale University|