Ketamine Infusion for Adolescent Depression and Anxiety
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|ClinicalTrials.gov Identifier: NCT02579928|
Recruitment Status : Completed
First Posted : October 20, 2015
Results First Posted : March 16, 2020
Last Update Posted : July 14, 2020
|Condition or disease||Intervention/treatment||Phase|
|Major Depressive Disorder Anxiety Disorder||Drug: Ketamine Drug: Midazolam||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||17 participants|
|Intervention Model:||Crossover Assignment|
|Intervention Model Description:||Participants were randomly assigned the treatment order, with participants receiving a single infusion of either ketamine hydrochloride (0.5 mg/kg) or midazolam (0.045 mg/kg) on Day 1, and the alternate compound 2 weeks later.|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Masking Description:||Midazolam was chosen as an active placebo in keeping with its similar pharmacokinetic profile and precedent as a reasonable comparator for nonspecific behavioral effects of ketamine|
|Official Title:||Efficacy of Rapid-Acting NMDA Antagonist for Treatment of Adolescent Depression and Anxiety Disorders|
|Study Start Date :||October 2015|
|Actual Primary Completion Date :||September 28, 2018|
|Actual Study Completion Date :||September 2019|
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).
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.
Other Name: Ketalar
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),
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.
Other Name: Versed
- Montgomery-Asberg Depression Rating Scale Score 1 Day After Infusion [ Time Frame: 1 day after the 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.
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): NCT02579928
|United States, Connecticut|
|Hospital Research Unit at the Yale New Haven Hospital|
|New Haven, Connecticut, United States, 06510|
|Yale Child Study Center|
|New Haven, Connecticut, United States, 06520|
|Principal Investigator:||Michael H. Bloch, MD MS||Yale University|