Ketamine for Severe Adolescent Depression: Intermediate-term Safety and Efficacy (SAD-KIDS)
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ClinicalTrials.gov Identifier: NCT03889756 |
Recruitment Status :
Active, not recruiting
First Posted : March 26, 2019
Last Update Posted : April 15, 2022
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Sponsor:
Yale University
Information provided by (Responsible Party):
Yale University
Tracking Information | |||||||
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First Submitted Date ICMJE | March 22, 2019 | ||||||
First Posted Date ICMJE | March 26, 2019 | ||||||
Last Update Posted Date | April 15, 2022 | ||||||
Actual Study Start Date ICMJE | July 17, 2019 | ||||||
Estimated Primary Completion Date | September 2022 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||||||
Change History | |||||||
Current Secondary Outcome Measures ICMJE | Not Provided | ||||||
Original Secondary Outcome Measures ICMJE | Not Provided | ||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title ICMJE | Ketamine for Severe Adolescent Depression: Intermediate-term Safety and Efficacy | ||||||
Official Title ICMJE | Ketamine for Severe Adolescent Depression: Intermediate-term Safety and Efficacy | ||||||
Brief Summary | The purpose of this study is to evaluate the intermediate-term efficacy and tolerability of a multiple-dosing ketamine infusion paradigm for the treatment of medication-refractory major depressive disorder (MDD). We are using a two-phase design. The first phase is a 3-week double blind parallel design clinical trial comparing 6 infusions of ketamine compared to 6 infusions of midazolam in 24 adolescents with treatment resistant depression. The primary outcome of this phase will be Children's Depression Rating Scale (CDRS) score at Day 18. The second phase is a 6-month open phase in which patients who received midazolam and remain depressed with be offered open ketamine treatment (6 infusions over 3 weeks). All participants will be followed weekly for 6 months and tracked for time to relapse. | ||||||
Detailed Description | The purpose of this study is to evaluate the intermediate-term efficacy and tolerability of a multiple-dosing ketamine infusion paradigm for the treatment of medication-refractory major depressive disorder (MDD). The specific aims of the study are: To evaluate the efficacy and tolerability of a multiple-dosing ketamine infusion paradigm (2 infusions per week for 3 weeks) compared to midazolam in adolescents with treatment resistant depression (TRD), . To test these aims we have designed a two-phase trial. The first phase is a 3-week double blind parallel design clinical trial comparing 6 infusions of ketamine compared to 6 infusions of midazolam in 24 adolescents with TRD. The primary outcome of this phase will be Children's Depression Rating Scale (CDRS) score at Day 18. The second phase is a 6-month open phase in which patients who received midazolam and remain depressed with be offered open ketamine treatment (6 infusions over 3 weeks). All participants will be followed weekly for 6 months and tracked for time to relapse. In those who initially responded to ketamine, symptom triggered maintenance infusions will be offered during this 6-month time period. All participants will receive standard of care treatment in addition to experimental procedures, and will be tracked monthly with extensive neurocognitive assessments. | ||||||
Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Phase 2 Phase 3 |
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Study Design ICMJE | 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
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Condition ICMJE | Major Depressive Disorder | ||||||
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 | Active, not recruiting | ||||||
Estimated Enrollment ICMJE |
24 | ||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||
Estimated Study Completion Date ICMJE | November 2022 | ||||||
Estimated Primary Completion Date | September 2022 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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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 | NCT03889756 | ||||||
Other Study ID Numbers ICMJE | 2000023857 | ||||||
Has Data Monitoring Committee | Not Provided | ||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||||
Responsible Party | Yale University | ||||||
Study Sponsor ICMJE | Yale University | ||||||
Collaborators ICMJE | Not Provided | ||||||
Investigators ICMJE |
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PRS Account | Yale University | ||||||
Verification Date | April 2022 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |