A Phase 4 interventional study of Ketamine and Midazolam in Major Depressive Disorder and Anxiety Disorder, sponsored by Yale University. Completed at 2 sites in United States. Open to participants aged 13 Years to 17 Years. Per ClinicalTrials.gov, last updated 2020-07-14.
Sponsored by Yale University · Phase 4, Interventional, and Treatment
The purpose of this study is to determine the tolerability and short-term efficacy of a single ketamine infusion for the treatment of adolescents with 1) medication-refractory major depressive disorder (MDD) and/or 2) medication-refractory anxiety disorders (social anxiety disorder, panic disorder, generalized anxiety disorder and/or separation anxiety disorder).
We will conduct a crossover trial in which as many as 36 adolescents (18 with MDD and 18 with anxiety disorders) will be given a single infusion of ketamine (study drug) or midazolam (active control). MDD symptoms and anxiety symptoms will be monitored over a two-week period. If applicable, comorbid school refusal symptoms will also be monitored over a two-week period for both cohorts. A 2-week washout period will be required between infusion doses. Our primary outcomes will be 1) improvement in MDD symptoms (measured by Montgomery-Asberg Depression Rating Scale, revised (MADRS) score) 1 day after infusion, for the cohort of subjects enrolled in the MDD arm of this trial and 2) improvement in the anxiety symptoms (measured by the Multimodal Anxiety Scale for Children (MASC) acute physical symptoms subscale) for the cohort of subjects enrolled in the anxiety disorders arm of the trial.
8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.
This study's enrollment of 17 is below the median of 84 across 6,720 interventional studies indexed under Depression.
Browse Depression studies →Yale University is the lead sponsor of 1,724 studies on the registry; 298 are open to participants now.
Of its 210 completed or terminated interventional studies of FDA-regulated products, 126 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
MDD Cohort:
Anxiety Cohort:
Both cohorts:
Exclusion:
Participants were randomly be assigned to receive a dose of 0.5 mg/kg of Ketamine (administered intravenously over 40 minutes with a maximum total dose allowed in this study will be 50mg).
Drug: Ketamine
Participants were randomly assigned to receive a dose of 0.045mg/kg of Midazolam (administered Intravenously over 40 minutes with a the maximum total dose allowed in this study of 4.5mg),
Drug: Midazolam
A single dose of 0.5mg/kg of Ketamine will be administered Intravenously during 40 minutes in the Hospital Research Unit of YNHH. The subject will be monitored continuously during the procedure, and every hour for three hours after the infusion.
Also known as: Ketalar
A single dose of 0.045mg/kg of Midazolam will be administered intravenously during 40 minutes in the Hospital Research Unit of YNHH. The subject will be monitored continuously during the procedure, and every hour for three hours after the infusion.
Also known as: Versed
Montgomery-Asberg Depression Rating Scale Score 1 Day After Infusion
Depressive symptoms (measured by Montgomery-Asberg Depression Rating Scale, revised (MADRS) score) on 1 day after infusion, for the cohort of subjects enrolled in the MDD arm of this trial. Higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60. Usual cutoff points are: 0 to 6 - normal /symptom absent. 7 to 19 - mild depression. 20 to 34 - moderate depression. \>34 - severe depression.
Time frame: 1 day after the infusion
Adolescents (aged 13 to 17 years old) were recruited via (1) physician referral or (2) via direct inquiries from families via ClinicalTrials.gov listing. Subjects were enrolled at the Yale Child Study Center (New Haven, CT) between May 2016 and September 2018.
| Milestone | Ketamine First Then Midazolam | Midazolam First Then Ketamine |
|---|---|---|
| Started | 6 | 11 |
| Completed | 5 | 11 |
| Not completed | 1 | 0 |
| Withdrew: Withdrawal by subject | 1 | 0 |
Depressive symptoms (measured by Montgomery-Asberg Depression Rating Scale, revised (MADRS) score) on 1 day after infusion, for the cohort of subjects enrolled in the MDD arm of this trial. Higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60. Usual cutoff points are: 0 to 6 - normal /symptom absent. 7 to 19 - mild depression. 20 to 34 - moderate depression. \>34 - severe depression.
| units on a scale | Ketamine | Midazolam |
|---|---|---|
| Montgomery-Asberg Depression Rating Scale Score 1 Day After Infusion | 15.44 (10.51 to 20.37) | 24.13 (18.21 to 30.04) |
Collected over 1 hour after after infusion.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Ketamine | 0/17 (0%) | 0/17 (0%) | 15/17 (88.2%) |
| Midazolam | 0/16 (0%) | 0/16 (0%) | 13/16 (81.3%) |
| Event | Ketamine | Midazolam |
|---|---|---|
| Feeling like I am in a dreamNervous system disorders | 15/17 | 1/16 |
| Spaced outNervous system disorders | 14/17 | 13/16 |
| Disconnected from bodyNervous system disorders | 12/17 | 2/16 |
| Feeling like thigs are in slow motionNervous system disorders | 11/17 | 1/16 |
| Body parts feel large or smallNervous system disorders | 11/17 | 0/16 |
| Time is moving quicklyNervous system disorders | 11/17 | 1/16 |
| Feeling like you are in a movie or are a robotNervous system disorders | 9/17 | 1/16 |
| Objects appear differentNervous system disorders | 9/17 | 0/16 |
| Sounds changedNervous system disorders | 9/17 | 0/16 |
| World appears in a fogNervous system disorders | 7/17 | 1/16 |
| Age, Categorical(Participants) | Received Ketamine in the First Infusion | Received Midazolam in the First Infusion | Total |
|---|---|---|---|
| <=18 years | 6 | 11 | 17 |
| Between 18 and 65 years | 0 | 0 | 0 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Received Ketamine in the First Infusion | Received Midazolam in the First Infusion | Total |
|---|---|---|---|
| Mean | 15.3 (13 to 17) | 15.6 (13 to 17) | 15.4 (13 to 17) |
| Sex: Female, Male(Participants) | Received Ketamine in the First Infusion | Received Midazolam in the First Infusion | Total |
|---|---|---|---|
| Female | 5 | 8 | 13 |
| Male | 1 | 3 | 4 |
| Race (NIH/OMB)(Participants) | Received Ketamine in the First Infusion | Received Midazolam in the First Infusion | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 1 | 0 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 2 | 2 |
| White | 5 | 9 | 14 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Baseline Score for the Montgomery-Asberg Depression Rating Scale sc ore(units on a scale) | Received Ketamine in the First Infusion | Received Midazolam in the First Infusion | Total |
|---|---|---|---|
| Mean | 35.6 ± 7.1 | 31.8 ± 10.2 | 32.9 ± 9.1 |
Documents are hosted by the registry — open the source record to download them.
This study is completed, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Yale University