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NMDA Receptor Antagonist

Ketamine infusion for Depression (SAD-KIDS Trial)

Phase 2 & 3

Waitlist Available

Led By Michael H. Bloch, MD

Research Sponsored by Yale University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 18

Awards & highlights

SAD-KIDS Trial Summary

This trial is comparing ketamine infusions to midazolam infusions in adolescents with treatment-resistant depression, in order to study the efficacy and tolerability of ketamine as a treatment for major depressive disorder.

Eligible Conditions

Depression

SAD-KIDS Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 18

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 18

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 18 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Efficacy of a Multiple-dosing Ketamine Infusion Paradigm (2 Infusions Per Week for 3 Weeks) Compared to Midazolam in Adolescents With Treatment Resistant Depression Using the Children's Depression Rating Scale (CDRS)

Tolerability of a Multiple-dosing Ketamine Infusion Paradigm (2 Infusions Per Week for 3 Weeks) Compared to Midazolam in Adolescents With Treatment Resistant Depression

Side effects data

From 2015 Phase 2 trial • 15 Patients • NCT01100255

20%

Dizziness

13%

Nausea

13%

Headache

Vomiting

100%

80%

60%

40%

20%

Study treatment Arm

Ketamine Infusion

Saline Infusion

SAD-KIDS Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: KetamineExperimental Treatment1 Intervention

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.

Group II: MidazolamPlacebo Group1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ketamine infusion

2010

Completed Phase 2

~20

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