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
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Sponsor:
Yale University
Collaborator:
American Academy of Child Adolescent Psychiatry.
Information provided by (Responsible Party):
Yale University
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Tracking Information | ||||
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First Submitted Date ICMJE | October 16, 2015 | |||
First Posted Date ICMJE | October 20, 2015 | |||
Results First Submitted Date ICMJE | December 5, 2019 | |||
Results First Posted Date ICMJE | March 16, 2020 | |||
Last Update Posted Date | July 14, 2020 | |||
Study Start Date ICMJE | October 2015 | |||
Actual Primary Completion Date | September 28, 2018 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
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.
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Original Primary Outcome Measures ICMJE |
Improvement in depressive symptoms [ Time Frame: 1 day after the infusion ] Our primary outcome will be improvement in depressive symptoms as measured by Children's Depression Rating Scale, revised (CDRS-R) score, 1 day after infusion.
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Change History | ||||
Current Secondary Outcome Measures ICMJE | Not Provided | |||
Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Ketamine Infusion for Adolescent Depression and Anxiety | |||
Official Title ICMJE | Efficacy of Rapid-Acting NMDA Antagonist for Treatment of Adolescent Depression and Anxiety Disorders | |||
Brief Summary | 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). | |||
Detailed Description | 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. | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 4 | |||
Study Design ICMJE | Allocation: Randomized 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 Primary Purpose: Treatment
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
17 | |||
Original Estimated Enrollment ICMJE |
18 | |||
Actual Study Completion Date ICMJE | September 2019 | |||
Actual Primary Completion Date | September 28, 2018 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion: MDD Cohort:
Anxiety Cohort:
Both cohorts:
Exclusion:
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Sex/Gender ICMJE |
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Ages ICMJE | 13 Years to 17 Years (Child) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT02579928 | |||
Other Study ID Numbers ICMJE | 1506016041 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Yale University | |||
Study Sponsor ICMJE | Yale University | |||
Collaborators ICMJE | American Academy of Child Adolescent Psychiatry. | |||
Investigators ICMJE |
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PRS Account | Yale University | |||
Verification Date | June 2020 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |