Ketamine for Severe Adolescent Depression: Intermediate-term Safety and Efficacy (SAD-KIDS)
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|ClinicalTrials.gov Identifier: NCT03889756|
Recruitment Status : Not yet recruiting
First Posted : March 26, 2019
Last Update Posted : July 23, 2019
|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|
|Estimated Study Start Date :||August 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03889756
|Contact: David Zakur||203 email@example.com|
|Contact: Jennifer Dwyer, MD||203 firstname.lastname@example.org|
|Principal Investigator:||Michael H. Bloch, MD||Yale University|