Ketamine for Severe Adolescent Depression: Intermediate-term Safety and Efficacy (SAD-KIDS)
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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 : April 15, 2022
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Condition or disease | Intervention/treatment | Phase |
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Major Depressive Disorder | Drug: Ketamine infusion Drug: Midazolam infusion | Phase 2 Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 24 participants |
Allocation: | Randomized |
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. |
Primary Purpose: | Treatment |
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 |

Arm | Intervention/treatment |
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Experimental: Ketamine
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.
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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.
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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

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Ages Eligible for Study: | 13 Years to 17 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Male or female ages 13-17 years
- Meet DSM-5 (Diagnostic and Statistical Manual 5 ) criteria for Major Depressive Disorder by structured interview (MINI-KID)
- Children's Depression Rating Scale, Revised CDRS score ≥40 at screening
- Failure to achieve remission with at least 2 antidepressant trials (e.g. SSRI, SNRI or TCA), meaning at least 6 weeks at therapeutic dosing, including at least 4 weeks of stable dosing
- Stable psychiatric medications and doses for the month prior to enrollment. Subjects may continue to engage in any ongoing psychotherapy.
- Medically and neurologically healthy on the basis of physical examination and medical history.
- Parents able to provide written informed consent and adolescents must additionally provide assent.
Exclusion Criteria:
- History of psychotic disorder, manic episode, autism spectrum disorder diagnosed by MINI-KID
- History of substance dependence diagnosis by MINI-KID (excluding tobacco) or positive urine toxicology.
- Intellectual disability (IQ<70) per medical history
- Pregnancy (urine pregnancy tests on the day of infusions for menstruating girls) or lactation
- Prior treatment with ketamine for depression or prior recreational use of ketamine.
- Inability to provide written informed consent according to the Yale Human Investigation Committee (HIC) guidelines in English.

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 |
Responsible Party: | Yale University |
ClinicalTrials.gov Identifier: | NCT03889756 |
Other Study ID Numbers: |
2000023857 |
First Posted: | March 26, 2019 Key Record Dates |
Last Update Posted: | April 15, 2022 |
Last Verified: | April 2022 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
depression, ketamine |
Depression Depressive Disorder Depressive Disorder, Major Behavioral Symptoms Mood Disorders Mental Disorders Midazolam Ketamine Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anesthetics, Dissociative Anesthetics, Intravenous |
Anesthetics, General Anesthetics Central Nervous System Depressants Excitatory Amino Acid Antagonists Excitatory Amino Acid Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Adjuvants, Anesthesia Hypnotics and Sedatives Anti-Anxiety Agents Tranquilizing Agents Psychotropic Drugs GABA Modulators GABA Agents |