Ketamine Infusion for Adolescent Depression and Anxiety
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|ClinicalTrials.gov Identifier: NCT02579928|
Recruitment Status : Active, not recruiting
First Posted : October 20, 2015
Last Update Posted : November 15, 2018
|Condition or disease||Intervention/treatment||Phase|
|Major Depressive Disorder Anxiety Disorder||Drug: Ketamine Drug: Midazolam||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
|Estimated Study Completion Date :||June 2019|
A dose of 0.5 mg/kg of Ketamine will be administered intravenously over 40 minutes. The 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
Active Comparator: Midazolam
A dose of 0.045mg/kg of Midazolam will be administered Intravenously over 40 minutes. The maximum total dose allowed in this study will be 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
- Improvement in depressive symptoms [ Time Frame: 1 day after the infusion ]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
- Improvement in anxiety [ Time Frame: 1 day after the infusion ]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.
- Ketamine metabolites and D-serine [ Time Frame: 40 minutes (end of the infusion), 80 minutes, 110 minutes, and 230 minutes after each infusion ]Plasma levels
- Risk of suicidality [ Time Frame: Scored at Screening, 60 minutes before each infusion, 180 minutes after each infusion,at Day 1 /Day1+14, Day 2/Day 2 +14, Day 3/Day 3 + 14, Day5/ Day 5+14, Day 7/ Day 7+14, Day 10/ Day 10+14 and Day 14/ Day 14 + 14 ]Assessment with the Treatment-Emergent Activation and Suicidality Assessment Profile (TEASAP)
- Effect on school refusal behavior [ Time Frame: Scored at Screening, prior to each infusion, and Day 1 /Day1+14, Day 2/Day 2 +14, Day 3/Day 3 + 14, Day5/ Day 5+14, Day 7/ Day 7+14, Day 10/ Day 10+14 and Day 14/ Day 14 + 14 ]Examine ketamine's effects on school-refusal behavior (SRB) that is associated with anxiety and depression using the School Refusal Assessment Scale Child and Parent versions
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|